Trial Outcomes & Findings for Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes (NCT NCT04982575)
NCT ID: NCT04982575
Last Updated: 2025-12-23
Results Overview
Change in HbA1c from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. The on-treatment without rescue medication period is a subset of the 'on-treatment' observation period and represents the time period where subjects are considered exposed to trial product but have not initiated any rescue medications.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
Week 0, Week 32
Results posted on
2025-12-23
Participant Flow
The trial was conducted at 17 sites in the United States.
After randomisation, participants were to continue their pre-trial metformin and sodium-glucose co-transporter-2 (SGLT2) inhibitor background medication throughout the entire trial. The background metformin and SGLT2 inhibitor were to be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period unless glycaemic rescue treatment was needed or adjustment was required due to safety concerns.
Participant milestones
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Cagrilintide 2.4 mg + Placebo (Semaglutide)
Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
31
|
|
Overall Study
COMPLETED
|
29
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Cagrilintide 2.4 mg + Placebo (Semaglutide)
Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
2
|
Baseline Characteristics
Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
n=31 Participants
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Cagrilintide 2.4 mg + Placebo (Semaglutide)
n=30 Participants
Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=31 Participants
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56 Years
STANDARD_DEVIATION 10 • n=68 Participants
|
62 Years
STANDARD_DEVIATION 7 • n=4 Participants
|
57 Years
STANDARD_DEVIATION 10 • n=219 Participants
|
58 Years
STANDARD_DEVIATION 9 • n=219 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=68 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=219 Participants
|
33 Participants
n=219 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=68 Participants
|
23 Participants
n=4 Participants
|
18 Participants
n=219 Participants
|
59 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=68 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=219 Participants
|
29 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=68 Participants
|
24 Participants
n=4 Participants
|
18 Participants
n=219 Participants
|
63 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=219 Participants
|
4 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=219 Participants
|
1 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=68 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=219 Participants
|
15 Participants
n=219 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=68 Participants
|
22 Participants
n=4 Participants
|
24 Participants
n=219 Participants
|
72 Participants
n=219 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 32Population: Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Change in HbA1c from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. The on-treatment without rescue medication period is a subset of the 'on-treatment' observation period and represents the time period where subjects are considered exposed to trial product but have not initiated any rescue medications.
Outcome measures
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
n=30 Participants
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=30 Participants
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
Change from Baseline - in-trial
|
-2.2 Percentage of HbA1c
Standard Deviation 0.9
|
-1.9 Percentage of HbA1c
Standard Deviation 1.0
|
—
|
|
Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
Change from Baseline - on treatment without rescue
|
-2.2 Percentage of HbA1c
Standard Deviation 0.9
|
-2.0 Percentage of HbA1c
Standard Deviation 1.0
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 32Population: Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Change in HbA1c from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.
Outcome measures
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
n=30 Participants
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=30 Participants
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
|
-2.2 Percentage point of HbA1c
Standard Deviation 0.9
|
-0.8 Percentage point of HbA1c
Standard Deviation 0.9
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 32Population: Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Percenatge change in body weight from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.
Outcome measures
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
n=30 Participants
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=30 Participants
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
Percentage Change in Body Weight: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
|
-14.7 Percentage of body weight
Standard Deviation 9.3
|
-5.0 Percentage of body weight
Standard Deviation 4.0
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 32Population: Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Change in body weight from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.
Outcome measures
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
n=30 Participants
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=30 Participants
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
Change in Body Weight (Kilogram): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
|
-15.4 Kilogram
Standard Deviation 10.1
|
-5.3 Kilogram
Standard Deviation 4.2
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 32Population: Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Change in FPG from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.
Outcome measures
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
n=30 Participants
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=30 Participants
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide)
|
-3.4 Millimoles per liter (mmol/L)
Standard Deviation 3.1
|
-2.7 Millimoles per liter (mmol/L)
Standard Deviation 2.3
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 32Population: Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Change in mean glucose from baslline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.
Outcome measures
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
n=26 Participants
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=28 Participants
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
CGM: Change in Mean Glucose: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
|
-3.5 Millimoles per liter (mmol/l)
Standard Deviation 2.3
|
-1.0 Millimoles per liter (mmol/l)
Standard Deviation 2.2
|
—
|
SECONDARY outcome
Timeframe: At week 32Population: Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Percentage of TAR greater than 10.0 mmol/L (greater than 180 mg/dL) at week 32 is presented. The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range greater than 10.0 mmol/L (greater than 180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.
Outcome measures
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
n=26 Participants
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=28 Participants
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
Percentage of Time Above Range (TAR) Greater Than 10.0 mmol/L (Greater Than 180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
|
10.3 Percentage of time
Standard Deviation 15.7
|
30.9 Percentage of time
Standard Deviation 25.2
|
—
|
SECONDARY outcome
Timeframe: At week 32Population: Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Percentage of TIR 3.9-10.0 mmol/L (70-180 mg/dL) at week 32 is presented. The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site.
Outcome measures
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
n=26 Participants
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=28 Participants
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
Percentage of Time in Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide)
|
88.9 Percentage of time
Standard Deviation 15.3
|
68.9 Percentage of time
Standard Deviation 25.1
|
—
|
SECONDARY outcome
Timeframe: From baseline (week 0) to week 37Population: Safety analysis set included all randomised participants and who take at least 1 dose of trial product.
An adverse event (AE) is any untoward medical occurrence in a clinical trial participants administered or using a medicinal product, whether or not considered related to the medicinal product or usage. A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. On treatment observation period starts at the date of first dose of trial product and ends at the first date of any of the following; the date of last dose of trial product +35 days for AEs and hypoglycaemic episodes/+ 14 days for other endpoints; the end-date for the 'in-trial' observation period.
Outcome measures
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
n=31 Participants
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=30 Participants
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=31 Participants
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs)
|
21 Events
|
24 Events
|
22 Events
|
SECONDARY outcome
Timeframe: From baseline (week 0) to week 37Population: Safety analysis set included all randomised participants and who take at least 1 dose of trial product.
Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG) meter or severe hypoglycaemic episodes (level 3) that occurred from week 0 to week 37 are presented. On treatment observation period starts at the date of first dose of trial product and ends at the first date of any of the following; the date of last dose of trial product +35 days for AEs and hypoglycaemic episodes/+ 14 days for other endpoints; the end-date for the 'in-trial' observation period.
Outcome measures
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
n=31 Participants
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=30 Participants
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=31 Participants
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0mmol/L (54mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
Adverse Events
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Cagrilintide 2.4 mg + Placebo (Semaglutide)
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Semaglutide 2.4 mg + Placebo (Cagrilintide)
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
n=31 participants at risk
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Cagrilintide 2.4 mg + Placebo (Semaglutide)
n=30 participants at risk
Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=31 participants at risk
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.3%
1/30 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
General disorders
Chest pain
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.3%
1/30 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.3%
1/30 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.3%
1/30 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Vascular disorders
Hypotension
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/30 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.2%
1/31 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/30 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.2%
1/31 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.3%
1/30 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
Other adverse events
| Measure |
Cagrilintide 2.4 mg + Semaglutide 2.4 mg
n=31 participants at risk
Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Cagrilintide 2.4 mg + Placebo (Semaglutide)
n=30 participants at risk
Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
Semaglutide 2.4 mg + Placebo (Cagrilintide)
n=31 participants at risk
Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32).
|
|---|---|---|---|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.7%
2/30 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
1/31 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.3%
1/30 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.5%
2/31 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
2/31 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.3%
1/30 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.2%
1/31 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/30 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.5%
2/31 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Infections and infestations
COVID-19
|
16.1%
5/31 • Number of events 5 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
16.7%
5/30 • Number of events 5 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
9.7%
3/31 • Number of events 3 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/30 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
9.7%
3/31 • Number of events 3 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Constipation
|
16.1%
5/31 • Number of events 5 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
13.3%
4/30 • Number of events 4 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
12.9%
4/31 • Number of events 5 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.7%
2/30 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.3%
1/30 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.5%
2/31 • Number of events 3 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.7%
2/30 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.1%
5/31 • Number of events 7 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.7%
2/30 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.5%
2/31 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.7%
2/30 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.5%
2/31 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/30 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.5%
2/31 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Eructation
|
6.5%
2/31 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/30 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/30 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.5%
2/31 • Number of events 3 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
General disorders
Fatigue
|
9.7%
3/31 • Number of events 3 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.3%
1/30 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Infections and infestations
Gastroenteritis
|
6.5%
2/31 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.3%
1/30 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
9.7%
3/31 • Number of events 3 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.7%
3/31 • Number of events 3 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.3%
1/30 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Nervous system disorders
Headache
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
10.0%
3/30 • Number of events 3 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
9.7%
3/31 • Number of events 3 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.5%
2/31 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/30 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
General disorders
Injection site reaction
|
3.2%
1/31 • Number of events 4 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.7%
2/30 • Number of events 21 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Nausea
|
29.0%
9/31 • Number of events 10 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
13.3%
4/30 • Number of events 5 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
16.1%
5/31 • Number of events 7 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.3%
1/30 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.5%
2/31 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.7%
2/30 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Infections and infestations
Sinusitis
|
6.5%
2/31 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/30 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
2/31 • Number of events 3 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
6.7%
2/30 • Number of events 2 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
9.7%
3/31 • Number of events 3 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/31 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/30 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
9.7%
3/31 • Number of events 3 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
3/31 • Number of events 3 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
0.00%
0/30 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
3.2%
1/31 • Number of events 1 • From baseline (week 0) to week 37
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period starts at date of first dose of trial product \& ends at first date of any of following; date of last dose of trial product +35 days for AEs \& hypoglycaemic episodes/+ 14 days for other endpoints; end-date for in-trial observation period. SAS included all randomised participants and who take at least 1 dose of trial product.
|
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