Trial Outcomes & Findings for Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity (NCT NCT04998136)
NCT ID: NCT04998136
Last Updated: 2025-12-30
Results Overview
Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
Baseline (week 0), end of treatment (week 44)
Results posted on
2025-12-30
Participant Flow
The trial was conducted at 13 sites in Republic of Korea and Thailand.
The trial included an initial 16 weeks of dose escalation period and a 28 weeks of maintenance period. 150 eligible participants were randomized in a 2:1 manner to receive either Semaglutide or placebo once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Participant milestones
| Measure |
Semaglutide
Participants received 2.4 milligram (mg) semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
49
|
|
Overall Study
Full Analysis Set
|
101
|
49
|
|
Overall Study
Safety Analysis Set
|
101
|
49
|
|
Overall Study
COMPLETED
|
101
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity
Baseline characteristics by cohort
| Measure |
Semaglutide
n=101 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=49 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 Years
STANDARD_DEVIATION 10 • n=174 Participants
|
37 Years
STANDARD_DEVIATION 11 • n=166 Participants
|
39 Years
STANDARD_DEVIATION 11 • n=167 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=174 Participants
|
33 Participants
n=166 Participants
|
111 Participants
n=167 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=174 Participants
|
16 Participants
n=166 Participants
|
39 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=174 Participants
|
49 Participants
n=166 Participants
|
150 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Asian
|
101 Participants
n=174 Participants
|
49 Participants
n=166 Participants
|
150 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Body Weight (%) : In-trial Observation Period
|
-16.4 Percentage of body weight
Standard Deviation 7.3
|
-2.6 Percentage of body weight
Standard Deviation 5.8
|
PRIMARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: The time period where participants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.
Outcome measures
| Measure |
Semaglutide
n=96 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=47 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Body Weight (%) : On-treatment Observation Period
|
-16.4 Percentage of body weight
Standard Deviation 7.4
|
-2.7 Percentage of body weight
Standard Deviation 5.8
|
PRIMARY outcome
Timeframe: At week 44Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period
Yes
|
96 Participants
|
12 Participants
|
|
Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period
No
|
4 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: At week 44Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: the time period where partici-pants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.
Outcome measures
| Measure |
Semaglutide
n=96 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=47 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period
Yes
|
92 Participants
|
12 Participants
|
|
Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period
No
|
4 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: At week 44Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Number of participants who achieved body weight reduction more than or equal to 10 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no)
Yes
|
78 Participants
|
5 Participants
|
|
Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no)
No
|
22 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: At week 44Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Number of participants who achieved body weight reduction more than or equal to 15 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no)
Yes
|
53 Participants
|
2 Participants
|
|
Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no)
No
|
47 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: At week 44Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Number of participants who achieved body weight reduction more than or equal to 20 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no)
Yes
|
30 Participants
|
0 Participants
|
|
Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no)
No
|
70 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in waist circumference from baseline (week 0) to the end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Waist Circumference
|
-12.0 Centimeter (cm)
Standard Deviation 7.5
|
-3.0 Centimeter (cm)
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in body weight in kilogram (kg) is presented from baseline (week 0) to the end of treatment (week 44) and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Body Weight (kg)
|
-13.0 Kg
Standard Deviation 5.5
|
-2.0 Kg
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Body Mass Index
|
-4.9 Kilogram per square meter (kg/m^2)
Standard Deviation 2.1
|
-0.8 Kilogram per square meter (kg/m^2)
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Systolic Blood Pressure (mmHg)
|
-11 Millimeter of mercury (mmHg)
Standard Deviation 14
|
-1 Millimeter of mercury (mmHg)
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in diastolic blood pressure from baseline (week 0) to end of the treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
-4 MmHg
Standard Deviation 11
|
0 MmHg
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in total cholesterol in milligram per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Total Cholesterol (mg/dL) - Ratio to Baseline
|
0.91 Ratio of total cholesterol
Geometric Coefficient of Variation 15.7
|
1.03 Ratio of total cholesterol
Geometric Coefficient of Variation 12.3
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in total cholesterol in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Total Cholesterol (mmol/L) - Ratio to Baseline
|
0.91 Ratio of total cholesterol
Geometric Coefficient of Variation 15.7
|
1.03 Ratio of total cholesterol
Geometric Coefficient of Variation 12.3
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in HDL cholesterol in mg/dL from (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=99 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline
|
1.00 Ratio of HDL cholesterol
Geometric Coefficient of Variation 15.3
|
1.04 Ratio of HDL cholesterol
Geometric Coefficient of Variation 13.7
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=99 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
|
1.00 Ratio of HDL cholesterol
Geometric Coefficient of Variation 15.3
|
1.04 Ratio of HDL cholesterol
Geometric Coefficient of Variation 13.7
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=99 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline
|
0.93 Ratio of LDL cholesterol
Geometric Coefficient of Variation 25.6
|
1.04 Ratio of LDL cholesterol
Geometric Coefficient of Variation 21.6
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=99 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
|
0.93 Ratio of LDL cholesterol
Geometric Coefficient of Variation 25.6
|
1.04 Ratio of LDL cholesterol
Geometric Coefficient of Variation 21.6
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Triglycerides (mg/dL) - Ratio to Baseline
|
0.72 Ratio of triglycerides
Geometric Coefficient of Variation 40.9
|
0.96 Ratio of triglycerides
Geometric Coefficient of Variation 42.1
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in Triglycerides (mmol/L) - Ratio to Baseline
|
0.72 Ratio of triglycerides
Geometric Coefficient of Variation 40.9
|
0.96 Ratio of triglycerides
Geometric Coefficient of Variation 42.1
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in hsCRP in milligram per liter (mg/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=48 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline
|
0.54 Ratio of hsCRP
Geometric Coefficient of Variation 170.0
|
0.89 Ratio of hsCRP
Geometric Coefficient of Variation 73.7
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=47 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in HbA1c (%)
|
-0.4 Percentage of HbA1c
Standard Deviation 0.3
|
0.0 Percentage of HbA1c
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline (week 0), end of treatment (week 44)Population: FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure.
Change in glycosylated heamoglobin (HbA1c) in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Outcome measures
| Measure |
Semaglutide
n=100 Participants
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=47 Participants
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Change in HbA1c (mmol/Mol)
|
-4.5 Mmol/mol
Standard Deviation 3.2
|
-0.1 Mmol/mol
Standard Deviation 2.3
|
Adverse Events
Semaglutide
Serious events: 13 serious events
Other events: 80 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Semaglutide
n=101 participants at risk
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=49 participants at risk
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/101 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
2.0%
1/49 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Infections and infestations
Chikungunya virus infection
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic cyst
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/101 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
2.0%
1/49 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
2/101 • Number of events 2 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
2.0%
1/49 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/101 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
2.0%
1/49 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/101 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
2.0%
1/49 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Psychiatric disorders
Major depression
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Injury, poisoning and procedural complications
Nasal injury
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Infections and infestations
Pneumonia
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.99%
1/101 • Number of events 1 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
Other adverse events
| Measure |
Semaglutide
n=101 participants at risk
Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
Placebo
n=49 participants at risk
Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.9%
7/101 • Number of events 7 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
0.00%
0/49 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
4/101 • Number of events 4 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
10.2%
5/49 • Number of events 5 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Infections and infestations
COVID-19
|
14.9%
15/101 • Number of events 17 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
32.7%
16/49 • Number of events 16 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Gastrointestinal disorders
Constipation
|
21.8%
22/101 • Number of events 24 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
16.3%
8/49 • Number of events 10 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.9%
13/101 • Number of events 14 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
4.1%
2/49 • Number of events 2 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.7%
28/101 • Number of events 43 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
6.1%
3/49 • Number of events 3 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Nervous system disorders
Dizziness
|
10.9%
11/101 • Number of events 13 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
6.1%
3/49 • Number of events 4 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.9%
12/101 • Number of events 18 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
10.2%
5/49 • Number of events 5 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Infections and infestations
Gastroenteritis
|
5.0%
5/101 • Number of events 5 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
6.1%
3/49 • Number of events 3 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Nervous system disorders
Headache
|
12.9%
13/101 • Number of events 20 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
6.1%
3/49 • Number of events 7 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
11.9%
12/101 • Number of events 16 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
24.5%
12/49 • Number of events 17 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Gastrointestinal disorders
Nausea
|
37.6%
38/101 • Number of events 57 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
14.3%
7/49 • Number of events 8 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.9%
8/101 • Number of events 9 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
14.3%
7/49 • Number of events 10 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
11/101 • Number of events 13 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
4.1%
2/49 • Number of events 3 • From (week 0) to (week 49).
All presented AEs are TEAEs (treatment emergent adverse events). Adverse events will be defined as "treatment-emergent" (TEAE), if the onset of the event occurs in the on-treatment period. Safety analysis set (SAS): All participants who were exposed to at least one dose of randomised IMP. Participants were included in the analyses according to the intervention they actually received.
|
Additional Information
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