Trial Outcomes & Findings for Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (NCT NCT03548987)
NCT ID: NCT03548987
Last Updated: 2022-01-19
Results Overview
Change in body weight from baseline (week 20) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
902 participants
Primary outcome timeframe
Randomisation (week 20) to week 68
Results posted on
2022-01-19
Participant Flow
The trial was conducted in 73 sites in Denmark (2), Israel (6), Netherlands (3), Portugal (6), South Africa (6), Spain (7), Sweden (4), Switzerland (6), Ukraine (5) and United States (28).
The trial included 20-week run-in period and 48-week maintenance period. During the run-in period, participant started with a semaglutide dose of 0.25 mg and the dose was increased every fourth week until the target dose, 2.4 mg was reached. Out of 902 participants, 803 have completed the run-in period. Thus, these were randomised in 2:1 ratio either to receive semaglutide 2.4 mg or placebo. The treatment is an adjunct to reduced-calorie diet and increased physical activity.
Participant milestones
| Measure |
Semaglutide 2.4 mg
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Run-in Period (Week 0 to Week 20)
STARTED
|
902
|
0
|
|
Run-in Period (Week 0 to Week 20)
Safety Analysis Set (SAS)
|
902
|
0
|
|
Run-in Period (Week 0 to Week 20)
COMPLETED
|
803
|
0
|
|
Run-in Period (Week 0 to Week 20)
NOT COMPLETED
|
99
|
0
|
|
Maintenance Period (Week 20 to Week 68)
STARTED
|
535
|
268
|
|
Maintenance Period (Week 20 to Week 68)
Full Analysis Set (FAS)
|
535
|
268
|
|
Maintenance Period (Week 20 to Week 68)
COMPLETED
|
504
|
237
|
|
Maintenance Period (Week 20 to Week 68)
NOT COMPLETED
|
31
|
31
|
Reasons for withdrawal
| Measure |
Semaglutide 2.4 mg
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Run-in Period (Week 0 to Week 20)
Other
|
9
|
0
|
|
Run-in Period (Week 0 to Week 20)
Lost to Follow-up
|
8
|
0
|
|
Run-in Period (Week 0 to Week 20)
Withdrawal by Subject
|
11
|
0
|
|
Run-in Period (Week 0 to Week 20)
Safety concern as judged by investigator
|
2
|
0
|
|
Run-in Period (Week 0 to Week 20)
Run-in failure
|
19
|
0
|
|
Run-in Period (Week 0 to Week 20)
Pregnancy
|
1
|
0
|
|
Run-in Period (Week 0 to Week 20)
Protocol Violation
|
1
|
0
|
|
Run-in Period (Week 0 to Week 20)
Adverse Event
|
48
|
0
|
|
Maintenance Period (Week 20 to Week 68)
other
|
12
|
23
|
|
Maintenance Period (Week 20 to Week 68)
Lost to Follow-up
|
2
|
1
|
|
Maintenance Period (Week 20 to Week 68)
Withdrawal by Subject
|
1
|
1
|
|
Maintenance Period (Week 20 to Week 68)
Pregnancy
|
2
|
0
|
|
Maintenance Period (Week 20 to Week 68)
Protocol Violation
|
1
|
0
|
|
Maintenance Period (Week 20 to Week 68)
Adverse Event
|
13
|
6
|
Baseline Characteristics
Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Baseline characteristics by cohort
| Measure |
Semaglutide 2.4 mg
n=535 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=268 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
Total
n=803 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 Years
STANDARD_DEVIATION 12 • n=93 Participants
|
46 Years
STANDARD_DEVIATION 12 • n=4 Participants
|
46 Years
STANDARD_DEVIATION 12 • n=27 Participants
|
|
Sex: Female, Male
Female
|
429 Participants
n=93 Participants
|
205 Participants
n=4 Participants
|
634 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
169 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
493 Participants
n=93 Participants
|
247 Participants
n=4 Participants
|
740 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
69 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
104 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
446 Participants
n=93 Participants
|
226 Participants
n=4 Participants
|
672 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Randomisation (week 20) to week 68Population: Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = participants with available data.
Change in body weight from baseline (week 20) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=535 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=268 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change From Randomisation to Week 68 in Body Weight (%)
In-trial
|
-8.3 Percentage point
Standard Deviation 8.1
|
6.5 Percentage point
Standard Deviation 7.7
|
|
Change From Randomisation to Week 68 in Body Weight (%)
On-treatment
|
-8.8 Percentage point
Standard Deviation 7.8
|
6.1 Percentage point
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in waist circumference from baseline (week 20) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=518 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=248 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Waist Circumference
|
-6.9 Centimeter (cm)
Standard Deviation 7.5
|
3.2 Centimeter (cm)
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in systolic blood pressure from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=518 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=248 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
0 Millimeters of mercury (mmHg)
Standard Deviation 14
|
5 Millimeters of mercury (mmHg)
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in diastolic blood pressure from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=518 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=248 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
0 mmHg
Standard Deviation 9
|
1 mmHg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The 0-100 scale scores from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. Change from week 20 in the domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on the data from in-trial observation period which is the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=515 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=245 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Physical Functioning Score (Short Form 36 [SF-36])
Change in physical functioning score (SF-36)
|
1.0 Scores on a scale
Standard Deviation 3.8
|
-1.2 Scores on a scale
Standard Deviation 4.5
|
|
Change in Physical Functioning Score (Short Form 36 [SF-36])
Change in SF-36 role-physical score
|
0.3 Scores on a scale
Standard Deviation 5.0
|
-0.9 Scores on a scale
Standard Deviation 5.3
|
|
Change in Physical Functioning Score (Short Form 36 [SF-36])
Change in SF-36 bodily pain score
|
0.5 Scores on a scale
Standard Deviation 7.0
|
-1.5 Scores on a scale
Standard Deviation 7.7
|
|
Change in Physical Functioning Score (Short Form 36 [SF-36])
Change in SF-36 general health score
|
0.3 Scores on a scale
Standard Deviation 5.2
|
-1.8 Scores on a scale
Standard Deviation 5.8
|
|
Change in Physical Functioning Score (Short Form 36 [SF-36])
Change in SF-36 vitality score
|
1.1 Scores on a scale
Standard Deviation 7.1
|
-2.1 Scores on a scale
Standard Deviation 7.6
|
|
Change in Physical Functioning Score (Short Form 36 [SF-36])
Change in SF-36 social functioning score
|
0.1 Scores on a scale
Standard Deviation 6.2
|
-1.8 Scores on a scale
Standard Deviation 6.9
|
|
Change in Physical Functioning Score (Short Form 36 [SF-36])
Change in SF-36 mental health score
|
0.2 Scores on a scale
Standard Deviation 6.2
|
-2.2 Scores on a scale
Standard Deviation 7.6
|
|
Change in Physical Functioning Score (Short Form 36 [SF-36])
Change in SF-36 physical component summary
|
0.8 Scores on a scale
Standard Deviation 4.9
|
-0.9 Scores on a scale
Standard Deviation 5.6
|
|
Change in Physical Functioning Score (Short Form 36 [SF-36])
Change in SF-36 mental component summary
|
0.0 Scores on a scale
Standard Deviation 6.2
|
-2.4 Scores on a scale
Standard Deviation 8.5
|
|
Change in Physical Functioning Score (Short Form 36 [SF-36])
Change in SF-36 role-emotional score
|
0.0 Scores on a scale
Standard Deviation 5.5
|
-2.2 Scores on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Randomisation (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in body weight from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=520 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=250 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Body Weight [Kilogram (Kg)]
|
-7.5 Kg
Standard Deviation 7.6
|
5.7 Kg
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in BMI from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=520 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=250 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
-2.7 Kilogram per square meter (kg/sqm)
Standard Deviation 2.7
|
2.0 Kilogram per square meter (kg/sqm)
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in HbA1c from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=515 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=246 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Haemoglobin A1c (HbA1c) [%]
|
-0.2 Percentage point of HbA1c
Standard Deviation 0.3
|
0.1 Percentage point of HbA1c
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in HbA1c from week 20 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=515 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=246 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in HbA1c [Millimoles Per Mole (mmol/Mol)]
|
-1.7 mmol/mol
Standard Deviation 2.8
|
1.2 mmol/mol
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in fasting plasma glucose from week 20 to week 68 is presented.The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=511 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=242 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Fasting Plasma Glucose [Milligrams Per Deciliter (mg/dL)]
|
-1.1 mg/dL
Standard Deviation 8.6
|
7.6 mg/dL
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in fasting plasma glucose from week 20 to week 68 is presented.The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=511 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=242 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Fasting Plasma Glucose [Millimoles Per Litre (mmol/L)]
|
-0.1 mmol/L
Standard Deviation 0.5
|
0.4 mmol/L
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in fasting serum insulin from baseline (week 20) to week 68 \[measured as milli-international units per milliliter (mIU/mL)\] is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=498 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=240 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Fasting Serum Insulin
|
0.81 Ratio of fasting serum insulin
Geometric Coefficient of Variation 60.9
|
1.03 Ratio of fasting serum insulin
Geometric Coefficient of Variation 64.6
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in fasting total cholesterol from baseline (week 20) to week 68 (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=517 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=245 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Total Cholesterol
|
1.05 Ratio of fasting total cholesterol
Geometric Coefficient of Variation 13.5
|
1.11 Ratio of fasting total cholesterol
Geometric Coefficient of Variation 14.4
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in fasting HDL from baseline (week 20) to week 68 (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=515 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=245 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in High-density Lipoproteins (HDL)
|
1.18 Ratio of fasting HDL cholesterol
Geometric Coefficient of Variation 13.2
|
1.18 Ratio of fasting HDL cholesterol
Geometric Coefficient of Variation 16.3
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in fasting LDL from baseline (week 20) to week 68 (measured as mmol/L) is presented as ratio to baseline.The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=517 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=245 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Low-density Lipoproteins (LDL)
|
1.01 Ratio of fasting LDL cholesterol
Geometric Coefficient of Variation 19.8
|
1.07 Ratio of fasting LDL cholesterol
Geometric Coefficient of Variation 21.3
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in fasting VLDL from baseline (week 20) to week 68 (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=517 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=245 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Very Low-density Lipoproteins (VLDL)
|
0.94 Ratio of fasting VLDL
Geometric Coefficient of Variation 33.6
|
1.12 Ratio of fasting VLDL
Geometric Coefficient of Variation 39.0
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in fasting free fatty acids from baseline (week 20) to week 68 (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=498 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=240 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Free Fatty Acids
|
0.78 Ratio of fasting free fatty acids
Geometric Coefficient of Variation 79.4
|
0.89 Ratio of fasting free fatty acids
Geometric Coefficient of Variation 73.1
|
SECONDARY outcome
Timeframe: Randomization (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
Change in fasting triglycerides from baseline (week 20) to week 68 (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=517 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=245 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Triglycerides
|
0.94 Ratio of fasting triglycerides
Geometric Coefficient of Variation 33.9
|
1.12 Ratio of fasting triglycerides
Geometric Coefficient of Variation 39.4
|
SECONDARY outcome
Timeframe: Randomisation (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
The number of participants achieving at least a 4.3-point increase in SF-36 physical functioning score from baseline (week 20) to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved 4.3 points of increase of the score and 'No' infers number of participants who have not achieved 4.3 points of increase of the score. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=515 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=245 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Subjects Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score
Yes
|
58 Participants
|
11 Participants
|
|
Subjects Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score
No
|
457 Participants
|
234 Participants
|
SECONDARY outcome
Timeframe: Randomisation (week 20) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
The number of participants with weight gain from the start of the randomised period (week 20) to week 68 is presented. In the reported data, 'Yes' infers number of participants who have gained weight and 'No' infers number of participants who have not gained weight. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=520 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=250 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Subjects Who Gain Weight (Yes/no)
Yes
|
79 Participants
|
206 Participants
|
|
Subjects Who Gain Weight (Yes/no)
No
|
441 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Run-in (week 0) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
The body weight change (%) from week 0 to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=520 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=250 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Body Weight
|
-17.7 Percentage point
Standard Deviation 9.8
|
-5.4 Percentage point
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Run-in (week 0) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
The number of participants who achieved less than (\<) 0% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved \<0% weight loss whereas 'No' infers number of participants who have not achieved \<0% weight loss.The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=520 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=250 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Subjects Who Achieve (Yes/no): Body Weight Reduction < 0%
Yes
|
22 Participants
|
51 Participants
|
|
Subjects Who Achieve (Yes/no): Body Weight Reduction < 0%
No
|
498 Participants
|
199 Participants
|
SECONDARY outcome
Timeframe: Run-in (week 0) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
The number of participants who achieved greater than or equal to (≥) 5% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 5% weight loss whereas 'No' infers number of participants who have not achieved ≥ 5% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=520 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=250 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 5%
Yes
|
461 Participants
|
119 Participants
|
|
Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 5%
No
|
59 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: Run-in (week 0) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
The number of participants who achieved ≥ 10% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 10% weight loss whereas 'No' infers number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=520 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=250 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 10%
Yes
|
411 Participants
|
51 Participants
|
|
Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 10%
No
|
109 Participants
|
199 Participants
|
SECONDARY outcome
Timeframe: Run-in (week 0) to week 68Population: FAS included all randomised participants. 'Overall Number of Participants Analyzed' = participants with available data.
The number of participants who achieved ≥ 15% weight loss from week 0 to week 68 is presented. In the reported data, 'Yes' infers number of participants who have achieved ≥ 15% weight loss whereas 'No' infers number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=520 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=250 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 15%
No
|
189 Participants
|
227 Participants
|
|
Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 15%
Yes
|
331 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Run-in (week 0) to randomisation (week 20)Population: SAS included all participants who received at least one dose of trial product.
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment (week 0-20 run-in period). The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=902 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Number of Treatment-emergent Adverse Events (AEs)
|
3775 Events
|
—
|
SECONDARY outcome
Timeframe: Randomisation (week 20) to week 75Population: SAS included all participants who received at least one dose of trial product. Only randomised subjects in the safety analysis set contribute.
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment (week 20-75). The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=535 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=268 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Number of Treatment-emergent AEs
|
1885 Events
|
779 Events
|
SECONDARY outcome
Timeframe: Run-in (week 0) to randomisation (week 20)Population: SAS included all participants who received at least one dose of trial product.
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred during run-in period from week 0 to week 20 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=902 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Number of Serious Adverse Events (SAEs)
|
23 Events
|
—
|
SECONDARY outcome
Timeframe: Randomisation (week 20) to week 75Population: SAS included all participants who received at least one dose of trial product. Only randomised subjects in the safety analysis set contribute.
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred during run-in period from week 0 to week 20 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68), including 7 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 7 consecutive missed doses (off-treatment period).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=535 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=268 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Number of Serious Adverse Events (SAEs)
|
51 Events
|
19 Events
|
SECONDARY outcome
Timeframe: Run-in (week 0) to randomisation (week 20)Population: SAS included all participants who received at least one dose of trial product. Only randomised subjects in the safety analysis set contribute.
Change in pulse rate from week 0 week to week 20 is presented. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=535 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=268 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Pulse
|
5 beats per minute (bpm)
Standard Deviation 9
|
5 beats per minute (bpm)
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Randomisation (week 20) to week 68Population: SAS included all participants who received at least one dose of trial product. Only randomised subjects in the safety analysis set contribute. 'Overall Number of Participants Analyzed' = participants with available data.
Change in pulse from week 20 and 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period.On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=495 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=234 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Pulse
|
-2 bpm
Standard Deviation 9
|
-5 bpm
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Run-in (week) 0 to randomization (week 20)Population: SAS included all participants who received at least one dose of trial product. Only randomised subjects in the safety analysis set contribute.
Change in amylase (measured as units per liter \[U/L\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=535 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=268 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Amylase
|
1.06 Ratio of amylase
Geometric Coefficient of Variation 18.7
|
1.02 Ratio of amylase
Geometric Coefficient of Variation 26.2
|
SECONDARY outcome
Timeframe: Randomisation (week 20) to week 68Population: SAS included all participants who received at least one dose of trial product. Only randomised subjects in the safety analysis set contribute. 'Overall Number of Participants Analyzed' = participants with available data.
Change in amylase (measured as U/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=494 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=233 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Amylase
|
1.06 Ratio of amylase
Geometric Coefficient of Variation 19.9
|
1.00 Ratio of amylase
Geometric Coefficient of Variation 24.9
|
SECONDARY outcome
Timeframe: Run-in (week 0) to randomization (week 20)Population: SAS included all participants who received at least one dose of trial product. Only randomised subjects in the safety analysis set contribute.
Change in lipase (measured as U/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=535 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=268 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Lipase
|
1.44 Ratio of lipase
Geometric Coefficient of Variation 40.2
|
1.39 Ratio of lipase
Geometric Coefficient of Variation 53.5
|
SECONDARY outcome
Timeframe: Randomisation (week 20) to week 68Population: SAS included all participants who received at least one dose of trial product. Only randomised subjects in the safety analysis set contribute. 'Overall Number of Participants Analyzed' = participants with available data.
Change in lipase (measured as U/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=494 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=233 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Lipase
|
0.94 ratio of lipase
Geometric Coefficient of Variation 37.8
|
0.68 ratio of lipase
Geometric Coefficient of Variation 51.7
|
SECONDARY outcome
Timeframe: Run-in (week 0) to randomization (week 20)Population: SAS included all participants who received at least one dose of trial product. Only randomised subjects in the safety analysis set contribute.
Change in calcitonin (measured as nanogram per liter (ng/L)\]) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=535 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=268 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Calcitonin
|
0.98 Ratio of Calcitonin
Geometric Coefficient of Variation 28.4
|
0.96 Ratio of Calcitonin
Geometric Coefficient of Variation 28.1
|
SECONDARY outcome
Timeframe: Randomisation (week 20) to week 68Population: SAS included all participants who received at least one dose of trial product. Only randomised subjects in the safety analysis set contribute. 'Overall Number of Participants Analyzed' = participants with available data.
Change in calcitonin (measured as ng/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Outcome measures
| Measure |
Semaglutide 2.4 mg
n=491 Participants
Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo
n=233 Participants
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20, to receive once weekly placebo until week 68.
|
|---|---|---|
|
Change in Calcitonin
|
1.00 Ratio of Calcitonin
Geometric Coefficient of Variation 24.8
|
0.95 Ratio of Calcitonin
Geometric Coefficient of Variation 25.5
|
Adverse Events
Semaglutide: Run-in Period
Serious events: 21 serious events
Other events: 670 other events
Deaths: 0 deaths
Semaglutide 2.4: Treatment Period
Serious events: 41 serious events
Other events: 295 other events
Deaths: 1 deaths
Placebo: Treatment Period
Serious events: 15 serious events
Other events: 114 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Semaglutide: Run-in Period
n=902 participants at risk
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in run-in period (week 0 to week 20) with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached.
|
Semaglutide 2.4: Treatment Period
n=535 participants at risk
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20. Thus, out of 803, 535 participants were continued to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo: Treatment Period
n=268 participants at risk
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20. Thus, out of 803, 268 participants were switched to receive once weekly placebo until week 68.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.22%
2/902 • Number of events 2 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Infections and infestations
Abscess neck
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.22%
2/902 • Number of events 2 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Surgical and medical procedures
Arthroscopic surgery
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.75%
2/268 • Number of events 2 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Hepatobiliary disorders
Biliary cyst
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Infections and infestations
Cellulitis
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.93%
5/535 • Number of events 5 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.75%
2/268 • Number of events 2 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
General disorders
Death
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage II
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
2/535 • Number of events 2 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Nervous system disorders
Hemiparaesthesia
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Vascular disorders
Hypertension
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Vascular disorders
Hypotension
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Infections and infestations
Induced abortion infection
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Product Issues
Lead dislodgement
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal zone lymphoma
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Nervous system disorders
Migraine
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
2/535 • Number of events 2 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Pregnancy, puerperium and perinatal conditions
Morning sickness
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.22%
2/902 • Number of events 2 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Surgical and medical procedures
Orthognathic surgery
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.33%
3/902 • Number of events 3 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 2 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Infections and infestations
Pertussis
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Nervous system disorders
Quadriplegia
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Nervous system disorders
Syncope
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/535 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
0.11%
1/902 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/902 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.19%
1/535 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
Other adverse events
| Measure |
Semaglutide: Run-in Period
n=902 participants at risk
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in run-in period (week 0 to week 20) with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached.
|
Semaglutide 2.4: Treatment Period
n=535 participants at risk
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20. Thus, out of 803, 535 participants were continued to receive once weekly semaglutide s.c 2.4 mg until week 68.
|
Placebo: Treatment Period
n=268 participants at risk
Participants were to receive once-weekly s.c injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL in 20 week run-in period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. The participants with target dose reached were randomised in 2:1 at week 20. Thus, out of 803, 268 participants were switched to receive once weekly placebo until week 68.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
5.5%
50/902 • Number of events 53 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
1.5%
8/535 • Number of events 10 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.75%
2/268 • Number of events 2 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
67/902 • Number of events 82 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
6.4%
34/535 • Number of events 45 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
3.0%
8/268 • Number of events 9 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.4%
49/902 • Number of events 64 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
3.7%
20/535 • Number of events 22 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
1.1%
3/268 • Number of events 3 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
21/902 • Number of events 23 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
4.7%
25/535 • Number of events 28 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
5.2%
14/268 • Number of events 16 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
26/902 • Number of events 28 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
5.2%
28/535 • Number of events 32 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
6.7%
18/268 • Number of events 19 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
200/902 • Number of events 232 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
11.6%
62/535 • Number of events 75 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
6.0%
16/268 • Number of events 18 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.3%
102/902 • Number of events 115 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
1.3%
7/535 • Number of events 7 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.00%
0/268 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.5%
212/902 • Number of events 309 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
14.4%
77/535 • Number of events 114 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
7.1%
19/268 • Number of events 26 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.4%
103/902 • Number of events 127 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
1.7%
9/535 • Number of events 9 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.75%
2/268 • Number of events 2 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Eructation
|
7.9%
71/902 • Number of events 88 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
2.6%
14/535 • Number of events 15 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
General disorders
Fatigue
|
7.4%
67/902 • Number of events 69 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
4.9%
26/535 • Number of events 29 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
2.2%
6/268 • Number of events 6 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Flatulence
|
5.5%
50/902 • Number of events 73 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
2.6%
14/535 • Number of events 44 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
1.1%
3/268 • Number of events 4 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.4%
58/902 • Number of events 60 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.93%
5/535 • Number of events 6 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
0.37%
1/268 • Number of events 1 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Nervous system disorders
Headache
|
10.6%
96/902 • Number of events 119 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
7.7%
41/535 • Number of events 48 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
3.7%
10/268 • Number of events 10 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Infections and infestations
Influenza
|
3.1%
28/902 • Number of events 28 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
7.3%
39/535 • Number of events 45 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
7.1%
19/268 • Number of events 23 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
92/902 • Number of events 102 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
10.8%
58/535 • Number of events 77 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
14.6%
39/268 • Number of events 54 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Nausea
|
46.8%
422/902 • Number of events 629 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
14.0%
75/535 • Number of events 104 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
4.9%
13/268 • Number of events 13 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
15.5%
140/902 • Number of events 239 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
10.1%
54/535 • Number of events 87 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
3.0%
8/268 • Number of events 13 • week 0 to week 75 Results are based on the SAS which included all participants who received at least one dose of semaglutide or placebo.
All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than the date of last dose + 7 weeks.
|
Additional Information
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Phone: (+1) 866-867-7178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER