Overweight, Obesity
Conditions
Brief summary
This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and dummy medicine, from the start to the end of the study. As well as taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either take NNC0174-0833, liraglutide or dummy medicine - which treatment participants get is decided by chance. Participants will need to take one injection once a week or once a day, depending on the treatment. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 8 months. Participants will have 12 clinic visits with the study doctor.
Interventions
DRUGNNC0174-0833
Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
Participants will get one dose of liraglutide 3.0 mg once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg daily. The participants will continue on 3.0 mg of liraglutide, once daily up to 26 weeks.
DRUGPlacebo (Liraglutide 3.0 mg)
Participants will get one dose of Placebo (liraglutide 3.0 mg) once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg. The participants will continue on Placebo (liraglutide 3.0 mg), once daily up to 26 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Intervention model description
This is a twelve-armed trial comprising of five (0.3, 0.6, 1.2, 2.4 and 4.5 mg OW) of NNC0174-0833 arms and liraglutide 3.0 mg OD arm as active treatment arms and the corresponding 6 placebo arms as comparators. Participants will be randomised 6:1 between the active treatment arms and the placebo arms. The five different NNC0174-0833 placebo arms and the one liraglutide placebo arm will be pooled into one placebo group for statistical analyses of the results.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older at the time of signing the informed consent. * Female subject of non-childbearing potential or Male subject who is surgically sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial'). * BMI equal to 30.0 kg/m\^2 or greater or BMI equal to 27.0 kg/m\^2 or greater with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension or dyslipidaemia (to be assessed at the investigator's discretion).
Exclusion criteria
* HbA1c equal to 48 mmol/mol (6.5 percentage) or greater as measured by the central laboratory at screening. * A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening irrespective of medical records.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (%) | From baseline (week 0) to week 26 | Change in body weight (%) from week 0 to week 26 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period and treatment adherent period, respectively. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. Treatment-adherent: a participant is treatment adherent until the first time of non-adherence defined as: participant has not been dosed with trial product within the prior 14 days; participant has received other weight management drug or bariatric surgery; participant has not reached target dose at a pre-specified week; After the pre-specified evaluation week for the target dose, the participant has not received the target dose ±10% within the prior 14 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks | Week 26 | Percentage of participants who achieved a weight loss ≥ 10% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model. |
| Change in Body Weight (Kg) | From baseline (week 0) to week 26 | Change in body weight (Kg) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. |
| Change in Waist Circumference | From baseline (week 0) to week 26 | Change in waist circumference from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. |
| Change in Total Cholesterol | From baseline (week 0) to week 26 | Change in total cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. |
| Change in High Density Lipoprotein (HDL) Cholesterol | From baseline (week 0) to week 26 | Change in HDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. |
| Change in Low Density Lipoprotein (LDL) Cholesterol | From baseline (week 0) to week 26 | Change in LDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. |
| Change in Very Low Density Lipoprotein (VLDL) Cholesterol | From baseline (week 0) to week 26 | Change in VLDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. |
| Change in Triglycerides | From baseline (week 0) to week 26 | Change in triglycerides from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. |
| Change in Glycosylated Haemoglobin (HbA1c) (%-Point) | From baseline (week 0) to week 26 | Change in HbA1c (measured as percentage point of HbA1c) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. |
| Change in HbA1c (mmol/Mol) | From baseline (week 0) to week 26 | Change in HbA1c (measured as millimoles per mole (mmol/mol)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. |
| Change in Fasting Plasma Glucose (FPG) (mmol/L) | From baseline (week 0) to week 26 | Change in FPG (measured as mmol/L)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. |
| Change in FPG (mg/dL) | From baseline (week 0) to week 26 | Change in FPG (measured as milligrams per decilitre (mg/dL)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. |
| Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks | Week 26 | Percentage of participants who achieved a weight loss of greater than or equal to (≥) 5% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model. |
| Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | From baseline (week 0) to week 26 | Percentage change in HOMA-IR from week 0 to week 26 is presented. Insulin resistance is a condition in which cells fail to respond to normal actions of hormone in body. HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. HOMA-IR = fasting serum insulin (micro international units per milliliter (μU/ml)) × fasting plasma glucose (millimoles per liter (mmol/l)) / 22.5. HOMA-IR scores are classified as follows: less than 1.0: considered Insulin sensitive, 0.5-1.4: considered Healthy, Above 1.8: considered Early insulin resistance; Above 2.7 is considered significant insulin resistance. HOMA-IR score ranges from 0-infinity (no upper limit). Higher the score, higher the level of insulin resistance. Endpoint was evaluated based on data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in in-trial period. |
| Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta) | From baseline (week 0) to week 26 | Change between the value of HOMA-beta cell function collected at Week 26 and HOMA-beta cell function collected at Week 0 is presented. The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 \* insulin (micro international units per milliliter (µIU/mL)) / fasting plasma glucose (millimoles per liter (mmol/L)) - 3.5. HOMA-beta score ranges from minus infinity to infinity (no limits). The higher the score the better beta-cell function for HOMA-beta. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. |
| Number of Treatment-emergent Adverse Events (TEAEs) | From week 0 to week 32 | An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide. |
| Number of Treatment-emergent Serious Adverse Events (TESAEs) | From week 0 to week 32 | An AE was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. Serious AE is an AE that resulted in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. All SAEs reported in the below table are TESAEs. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide. |
| Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide | From week 0 to week 32 | Number of participants with occurrence of anti-drug antibodies towards cagrilintide from randomisation from week 0 to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. This endpoint is applicable only for the cagrilintide treatment arms. |
| Change in Diastolic Blood Pressure (DBP) | From baseline (week 0) to week 26 | Blood pressure was measured in a sitting position after 5 minutes of rest. The end point is evaluated while the subject is treatment-adherent. A participant is treatment adherent until the first time of non-adherence defined as: a) the participant has not been dosed with trial product within the prior 14 days; b) the participant has received other weight management drug or bariatric surgery c) the participant has not reached target dose at a pre-specified week d) After the pre-specified evaluation week for the target dose, the participant has not received the target dose +/- 10 % within the prior 14 days. This endpoint is applicable only for the cagrilintide treatment arms. |
| Change in Systolic Blood Pressure (SBP) | From baseline (week 0) to week 26 | Blood pressure was measured in a sitting position after 5 minutes of rest. The end point is evaluated while the subject is treatment-adherent. A participant is treatment adherent until the first time of non-adherence defined as: a) the participant has not been dosed with trial product within the prior 14 days; b) the participant has received other weight management drug or bariatric surgery c) the participant has not reached target dose at a pre-specified week d) After the pre-specified evaluation week for the target dose, the participant has not received the target dose +/- 10 % within the prior 14 days. This endpoint is applicable only for the cagrilintide treatment arms. |
| Change in Pulse | From baseline (week 0) to week 26 | Change in pulse from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide. |
| Change in High Sensitivity C-reactive Protein (hsCRP) | From baseline (week 0) to week 26 | In the below table, hsCRP data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide. |
| Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity | From baseline (week 0) to week 26 | Due to the assay development issue faced by the laboratory, the Plasminogen Activator Inhibitor-1 (PAI-1) activity (mg/L) was not performed in the study. |
| Change in Renin Activity | From baseline (week 0) to week 26 | Change in renin activity from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide. |
| Change in Aldosterone | From baseline (week 0) to week 26 | Change in aldosterone from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide. |
| Change in Fasting Insulin | From baseline (week 0) to week 26 | In the below table, fasting insulin data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. |
Countries
Canada, Denmark, Finland, Ireland, Japan, Poland, Serbia, South Africa, United Kingdom, United States
Participant flow
Recruitment details
The trial was conducted at 57 sites in 10 countries as follows: Canada (5), Denmark (2), Finland (4), Ireland (1), Japan (3), Poland (3), Serbia (5), South Africa (5), United Kingdom (7), United States of America (22).
Pre-assignment details
Participants were randomized in a 6:1 ratio between the active treatment (cagrilintide and liraglutide) arms and the placebo arms. The five different cagrilintide placebo arms and the one liraglutide placebo arm were pooled into one placebo group in the main analyses. Participants received the treatments as an adjunct to reduced-calorie diet and increased physical activity.
Participants by arm
| Arm | Count |
|---|---|
| Cagrilintide 0.3 mg Participants were to receive once weekly subcutaneous (s.c.) injection of 0.3 milligrams (mg) cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. | 101 |
| Cagrilintide 0.6 mg Participants were to receive once weekly s.c. injection of 0.6 mg cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. | 100 |
| Cagrilintide 1.2 mg Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 1.2 mg was reached: 0.6 mg (week 0) and 1.2 mg (week 2 to week 26). | 102 |
| Cagrilintide 2.4 mg Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 2.4 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4 to week 26). | 102 |
| Cagrilintide 4.5 mg Participants were to receive once weekly s.c. injection of cagrilintide for 26 weeks, using NovoPen® 4 pen-injector. Participants initially received 0.6 mg of cagrilintide and the dose was then escalated every other week until the target dose of 4.5 mg was reached: 0.6 mg (week 0), 1.2 mg (week 2), 2.4 mg (week 4), 4.5 mg (week 6 to week 26). | 101 |
| Liraglutide 3.0 mg Participants were to receive once daily s.c. injection of liraglutide for 26 weeks, using PDS290 pen-injector. Participants initially received 0.6 mg of liraglutide and the dose was then escalated every other week until the target dose of 3.0 mg was reached: 0.6 mg (week 0), 1.2 mg (week 1), 1.8 mg (week 2), 2.4 mg (week 3), 3.0 mg (week 4 to week 26). | 99 |
| Pooled Placebo Participants were to receive once weekly / once daily s.c. injection of placebo matched to cagrilintide / liraglutide (0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg / 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, 3.0 mg ) for 26 weeks respectively. | 101 |
| Total | 706 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 | 3 | 1 | 4 | 4 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 | 3 | 0 | 2 |
Baseline characteristics
| Characteristic | Cagrilintide 0.3 mg | Cagrilintide 0.6 mg | Cagrilintide 1.2 mg | Cagrilintide 2.4 mg | Cagrilintide 4.5 mg | Liraglutide 3.0 mg | Pooled Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 53.5 Years STANDARD_DEVIATION 10.3 | 53.2 Years STANDARD_DEVIATION 11 | 52.1 Years STANDARD_DEVIATION 8.7 | 52.7 Years STANDARD_DEVIATION 9.8 | 51.5 Years STANDARD_DEVIATION 12.7 | 51.5 Years STANDARD_DEVIATION 9.3 | 51.4 Years STANDARD_DEVIATION 11.9 | 52.3 Years STANDARD_DEVIATION 10.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 4 Participants | 2 Participants | 3 Participants | 5 Participants | 4 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 99 Participants | 98 Participants | 100 Participants | 98 Participants | 94 Participants | 97 Participants | 685 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants | 14 Participants | 15 Participants | 11 Participants | 9 Participants | 13 Participants | 17 Participants | 92 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants | 5 Participants | 8 Participants | 9 Participants | 5 Participants | 0 Participants | 9 Participants | 45 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 5 Participants | 4 Participants | 2 Participants | 4 Participants | 4 Participants | 4 Participants | 24 Participants |
| Race/Ethnicity, Customized White | 77 Participants | 75 Participants | 75 Participants | 80 Participants | 83 Participants | 82 Participants | 71 Participants | 543 Participants |
| Sex: Female, Male Female | 56 Participants | 62 Participants | 63 Participants | 75 Participants | 56 Participants | 65 Participants | 59 Participants | 436 Participants |
| Sex: Female, Male Male | 45 Participants | 38 Participants | 39 Participants | 27 Participants | 45 Participants | 34 Participants | 42 Participants | 270 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 100 | 0 / 102 | 0 / 102 | 0 / 101 | 0 / 99 | 0 / 101 |
| other Total, other adverse events | 59 / 101 | 58 / 100 | 72 / 102 | 62 / 102 | 76 / 101 | 65 / 99 | 45 / 101 |
| serious Total, serious adverse events | 6 / 101 | 2 / 100 | 7 / 102 | 3 / 102 | 4 / 101 | 4 / 99 | 3 / 101 |
Outcome results
Primary
Change in Body Weight (%)
Change in body weight (%) from week 0 to week 26 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period and treatment adherent period, respectively. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. Treatment-adherent: a participant is treatment adherent until the first time of non-adherence defined as: participant has not been dosed with trial product within the prior 14 days; participant has received other weight management drug or bariatric surgery; participant has not reached target dose at a pre-specified week; After the pre-specified evaluation week for the target dose, the participant has not received the target dose ±10% within the prior 14 days.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Body Weight (%) | -6.1 Percentage point of body weight | Standard Deviation 3.9 |
| Cagrilintide 0.6 mg | Change in Body Weight (%) | -6.9 Percentage point of body weight | Standard Deviation 5.4 |
| Cagrilintide 1.2 mg | Change in Body Weight (%) | -8.5 Percentage point of body weight | Standard Deviation 5.4 |
| Cagrilintide 2.4 mg | Change in Body Weight (%) | -9.5 Percentage point of body weight | Standard Deviation 6.2 |
| Cagrilintide 4.5 mg | Change in Body Weight (%) | -10.8 Percentage point of body weight | Standard Deviation 5.5 |
| Liraglutide 3.0 mg | Change in Body Weight (%) | -8.5 Percentage point of body weight | Standard Deviation 5.6 |
| Pooled Placebo | Change in Body Weight (%) | -3.0 Percentage point of body weight | Standard Deviation 5.2 |
Comparison: Week 26 responses were analysed using an analysis of covariance (ANCOVA) model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.p-value: 0.000295% CI: [-4.58, -1.4]ANCOVA
Comparison: Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.p-value: <0.000195% CI: [-5.38, -2.17]ANCOVA
Comparison: Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.p-value: <0.000195% CI: [-7.77, -4.36]ANCOVA
Comparison: Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.p-value: <0.000195% CI: [-8.28, -5.09]ANCOVA
Comparison: Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.p-value: <0.000195% CI: [-9.42, -6.16]ANCOVA
Comparison: Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.p-value: <0.000195% CI: [-7.61, -4.35]ANCOVA
Comparison: Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.p-value: 0.000395% CI: [1.38, 4.6]ANCOVA
Comparison: Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.p-value: 0.008295% CI: [0.57, 3.84]ANCOVA
Comparison: Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.p-value: 0.920995% CI: [-1.82, 1.64]ANCOVA
Comparison: Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.p-value: 0.39695% CI: [-2.33, 0.92]ANCOVA
Comparison: Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.p-value: 0.031695% CI: [-3.46, -0.16]ANCOVA
Secondary
Change in Aldosterone
Change in aldosterone from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Time frame: From baseline (week 0) to week 26
Population: The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Aldosterone | 0.8 nanograms per deciliter (ng/dL) | Standard Deviation 5.4 |
| Cagrilintide 0.6 mg | Change in Aldosterone | 0.8 nanograms per deciliter (ng/dL) | Standard Deviation 6.3 |
| Cagrilintide 1.2 mg | Change in Aldosterone | 0.7 nanograms per deciliter (ng/dL) | Standard Deviation 5.2 |
| Cagrilintide 2.4 mg | Change in Aldosterone | 2.2 nanograms per deciliter (ng/dL) | Standard Deviation 7.1 |
| Cagrilintide 4.5 mg | Change in Aldosterone | 1.1 nanograms per deciliter (ng/dL) | Standard Deviation 5.9 |
| Liraglutide 3.0 mg | Change in Aldosterone | 1.0 nanograms per deciliter (ng/dL) | Standard Deviation 8.2 |
| Pooled Placebo | Change in Aldosterone | 0.5 nanograms per deciliter (ng/dL) | Standard Deviation 5.1 |
Secondary
Change in Body Weight (Kg)
Change in body weight (Kg) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Body Weight (Kg) | -6.6 Kilograms (kg) | Standard Deviation 4.3 |
| Cagrilintide 0.6 mg | Change in Body Weight (Kg) | -7.1 Kilograms (kg) | Standard Deviation 5.6 |
| Cagrilintide 1.2 mg | Change in Body Weight (Kg) | -9.0 Kilograms (kg) | Standard Deviation 6.3 |
| Cagrilintide 2.4 mg | Change in Body Weight (Kg) | -10.1 Kilograms (kg) | Standard Deviation 6.7 |
| Cagrilintide 4.5 mg | Change in Body Weight (Kg) | -11.8 Kilograms (kg) | Standard Deviation 6.8 |
| Liraglutide 3.0 mg | Change in Body Weight (Kg) | -9.1 Kilograms (kg) | Standard Deviation 6.4 |
| Pooled Placebo | Change in Body Weight (Kg) | -3.2 Kilograms (kg) | Standard Deviation 5.8 |
Secondary
Change in Diastolic Blood Pressure (DBP)
Blood pressure was measured in a sitting position after 5 minutes of rest. The end point is evaluated while the subject is treatment-adherent. A participant is treatment adherent until the first time of non-adherence defined as: a) the participant has not been dosed with trial product within the prior 14 days; b) the participant has received other weight management drug or bariatric surgery c) the participant has not reached target dose at a pre-specified week d) After the pre-specified evaluation week for the target dose, the participant has not received the target dose +/- 10 % within the prior 14 days. This endpoint is applicable only for the cagrilintide treatment arms.
Time frame: From baseline (week 0) to week 26
Population: The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Diastolic Blood Pressure (DBP) | -2.2 millimeter of mercury (mmHg) | Standard Deviation 5.9 |
| Cagrilintide 0.6 mg | Change in Diastolic Blood Pressure (DBP) | 0.8 millimeter of mercury (mmHg) | Standard Deviation 5 |
| Cagrilintide 1.2 mg | Change in Diastolic Blood Pressure (DBP) | -1.3 millimeter of mercury (mmHg) | Standard Deviation 6 |
| Cagrilintide 2.4 mg | Change in Diastolic Blood Pressure (DBP) | -1.2 millimeter of mercury (mmHg) | Standard Deviation 5.5 |
| Cagrilintide 4.5 mg | Change in Diastolic Blood Pressure (DBP) | -1.8 millimeter of mercury (mmHg) | Standard Deviation 6.3 |
| Liraglutide 3.0 mg | Change in Diastolic Blood Pressure (DBP) | -2.6 millimeter of mercury (mmHg) | Standard Deviation 5.5 |
Secondary
Change in Fasting Insulin
In the below table, fasting insulin data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Number analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Fasting Insulin | Week 26 | 93.07 Picomoles per liter (pmol/L) | Standard Error 6.44 |
| Cagrilintide 0.3 mg | Change in Fasting Insulin | Week 0 | 103.88 Picomoles per liter (pmol/L) | Standard Error 6.62 |
| Cagrilintide 0.6 mg | Change in Fasting Insulin | Week 0 | 97.43 Picomoles per liter (pmol/L) | Standard Error 6.73 |
| Cagrilintide 0.6 mg | Change in Fasting Insulin | Week 26 | 82.98 Picomoles per liter (pmol/L) | Standard Error 5.02 |
| Cagrilintide 1.2 mg | Change in Fasting Insulin | Week 26 | 79.39 Picomoles per liter (pmol/L) | Standard Error 4.53 |
| Cagrilintide 1.2 mg | Change in Fasting Insulin | Week 0 | 96.44 Picomoles per liter (pmol/L) | Standard Error 5.91 |
| Cagrilintide 2.4 mg | Change in Fasting Insulin | Week 0 | 90.05 Picomoles per liter (pmol/L) | Standard Error 4.7 |
| Cagrilintide 2.4 mg | Change in Fasting Insulin | Week 26 | 71.22 Picomoles per liter (pmol/L) | Standard Error 4.04 |
| Cagrilintide 4.5 mg | Change in Fasting Insulin | Week 26 | 78.67 Picomoles per liter (pmol/L) | Standard Error 5.42 |
| Cagrilintide 4.5 mg | Change in Fasting Insulin | Week 0 | 109.99 Picomoles per liter (pmol/L) | Standard Error 8.23 |
| Liraglutide 3.0 mg | Change in Fasting Insulin | Week 0 | 95.80 Picomoles per liter (pmol/L) | Standard Error 5.73 |
| Liraglutide 3.0 mg | Change in Fasting Insulin | Week 26 | 79.00 Picomoles per liter (pmol/L) | Standard Error 5.46 |
| Pooled Placebo | Change in Fasting Insulin | Week 26 | 86.55 Picomoles per liter (pmol/L) | Standard Error 5.59 |
| Pooled Placebo | Change in Fasting Insulin | Week 0 | 105.77 Picomoles per liter (pmol/L) | Standard Error 7.06 |
Secondary
Change in Fasting Plasma Glucose (FPG) (mmol/L)
Change in FPG (measured as mmol/L)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Fasting Plasma Glucose (FPG) (mmol/L) | 0.0 mmol/L | Standard Deviation 0.6 |
| Cagrilintide 0.6 mg | Change in Fasting Plasma Glucose (FPG) (mmol/L) | 0.0 mmol/L | Standard Deviation 0.5 |
| Cagrilintide 1.2 mg | Change in Fasting Plasma Glucose (FPG) (mmol/L) | -0.2 mmol/L | Standard Deviation 0.5 |
| Cagrilintide 2.4 mg | Change in Fasting Plasma Glucose (FPG) (mmol/L) | 0.0 mmol/L | Standard Deviation 0.7 |
| Cagrilintide 4.5 mg | Change in Fasting Plasma Glucose (FPG) (mmol/L) | -0.2 mmol/L | Standard Deviation 1 |
| Liraglutide 3.0 mg | Change in Fasting Plasma Glucose (FPG) (mmol/L) | -0.5 mmol/L | Standard Deviation 0.7 |
| Pooled Placebo | Change in Fasting Plasma Glucose (FPG) (mmol/L) | 0.0 mmol/L | Standard Deviation 0.6 |
Secondary
Change in FPG (mg/dL)
Change in FPG (measured as milligrams per decilitre (mg/dL)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in FPG (mg/dL) | -0.7 mg/dL | Standard Deviation 10.1 |
| Cagrilintide 0.6 mg | Change in FPG (mg/dL) | -0.6 mg/dL | Standard Deviation 8.9 |
| Cagrilintide 1.2 mg | Change in FPG (mg/dL) | -3.2 mg/dL | Standard Deviation 9.7 |
| Cagrilintide 2.4 mg | Change in FPG (mg/dL) | 0.0 mg/dL | Standard Deviation 12 |
| Cagrilintide 4.5 mg | Change in FPG (mg/dL) | -3.7 mg/dL | Standard Deviation 18.4 |
| Liraglutide 3.0 mg | Change in FPG (mg/dL) | -9.5 mg/dL | Standard Deviation 12.4 |
| Pooled Placebo | Change in FPG (mg/dL) | -0.5 mg/dL | Standard Deviation 11.7 |
Secondary
Change in Glycosylated Haemoglobin (HbA1c) (%-Point)
Change in HbA1c (measured as percentage point of HbA1c) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Glycosylated Haemoglobin (HbA1c) (%-Point) | 0.0 Percentage point of HbA1c | Standard Deviation 0.2 |
| Cagrilintide 0.6 mg | Change in Glycosylated Haemoglobin (HbA1c) (%-Point) | -0.1 Percentage point of HbA1c | Standard Deviation 0.2 |
| Cagrilintide 1.2 mg | Change in Glycosylated Haemoglobin (HbA1c) (%-Point) | -0.1 Percentage point of HbA1c | Standard Deviation 0.3 |
| Cagrilintide 2.4 mg | Change in Glycosylated Haemoglobin (HbA1c) (%-Point) | -0.1 Percentage point of HbA1c | Standard Deviation 0.3 |
| Cagrilintide 4.5 mg | Change in Glycosylated Haemoglobin (HbA1c) (%-Point) | -0.1 Percentage point of HbA1c | Standard Deviation 0.2 |
| Liraglutide 3.0 mg | Change in Glycosylated Haemoglobin (HbA1c) (%-Point) | -0.3 Percentage point of HbA1c | Standard Deviation 0.2 |
| Pooled Placebo | Change in Glycosylated Haemoglobin (HbA1c) (%-Point) | -0.1 Percentage point of HbA1c | Standard Deviation 0.2 |
Secondary
Change in HbA1c (mmol/Mol)
Change in HbA1c (measured as millimoles per mole (mmol/mol)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in HbA1c (mmol/Mol) | -0.5 mmol/mol | Standard Deviation 2.4 |
| Cagrilintide 0.6 mg | Change in HbA1c (mmol/Mol) | -0.6 mmol/mol | Standard Deviation 2.2 |
| Cagrilintide 1.2 mg | Change in HbA1c (mmol/Mol) | -0.8 mmol/mol | Standard Deviation 3 |
| Cagrilintide 2.4 mg | Change in HbA1c (mmol/Mol) | -1.0 mmol/mol | Standard Deviation 2.9 |
| Cagrilintide 4.5 mg | Change in HbA1c (mmol/Mol) | -1.2 mmol/mol | Standard Deviation 2.4 |
| Liraglutide 3.0 mg | Change in HbA1c (mmol/Mol) | -2.9 mmol/mol | Standard Deviation 2.7 |
| Pooled Placebo | Change in HbA1c (mmol/Mol) | -0.6 mmol/mol | Standard Deviation 2.7 |
Secondary
Change in High Density Lipoprotein (HDL) Cholesterol
Change in HDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in High Density Lipoprotein (HDL) Cholesterol | 1.5 mg/dL | Standard Deviation 6.1 |
| Cagrilintide 0.6 mg | Change in High Density Lipoprotein (HDL) Cholesterol | 1.9 mg/dL | Standard Deviation 6.9 |
| Cagrilintide 1.2 mg | Change in High Density Lipoprotein (HDL) Cholesterol | 1.1 mg/dL | Standard Deviation 7.3 |
| Cagrilintide 2.4 mg | Change in High Density Lipoprotein (HDL) Cholesterol | 1.8 mg/dL | Standard Deviation 5.6 |
| Cagrilintide 4.5 mg | Change in High Density Lipoprotein (HDL) Cholesterol | 2.6 mg/dL | Standard Deviation 6.9 |
| Liraglutide 3.0 mg | Change in High Density Lipoprotein (HDL) Cholesterol | 0.8 mg/dL | Standard Deviation 6.3 |
| Pooled Placebo | Change in High Density Lipoprotein (HDL) Cholesterol | 0.1 mg/dL | Standard Deviation 7 |
Secondary
Change in High Sensitivity C-reactive Protein (hsCRP)
In the below table, hsCRP data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Time frame: From baseline (week 0) to week 26
Population: The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment. Number analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cagrilintide 0.3 mg | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 0 | 4.5 milligrams per liter (mg/L) | Standard Deviation 6.7 |
| Cagrilintide 0.3 mg | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 26 | 3.5 milligrams per liter (mg/L) | Standard Deviation 3.5 |
| Cagrilintide 0.6 mg | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 0 | 4.6 milligrams per liter (mg/L) | Standard Deviation 3.9 |
| Cagrilintide 0.6 mg | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 26 | 3.4 milligrams per liter (mg/L) | Standard Deviation 3 |
| Cagrilintide 1.2 mg | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 0 | 4.5 milligrams per liter (mg/L) | Standard Deviation 5.8 |
| Cagrilintide 1.2 mg | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 26 | 4.6 milligrams per liter (mg/L) | Standard Deviation 8.8 |
| Cagrilintide 2.4 mg | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 0 | 5.8 milligrams per liter (mg/L) | Standard Deviation 7.2 |
| Cagrilintide 2.4 mg | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 26 | 4.0 milligrams per liter (mg/L) | Standard Deviation 5.5 |
| Cagrilintide 4.5 mg | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 0 | 5.4 milligrams per liter (mg/L) | Standard Deviation 7.5 |
| Cagrilintide 4.5 mg | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 26 | 3.4 milligrams per liter (mg/L) | Standard Deviation 4 |
| Liraglutide 3.0 mg | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 0 | 4.7 milligrams per liter (mg/L) | Standard Deviation 4.1 |
| Liraglutide 3.0 mg | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 26 | 3.5 milligrams per liter (mg/L) | Standard Deviation 3.4 |
| Pooled Placebo | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 0 | 4.6 milligrams per liter (mg/L) | Standard Deviation 6 |
| Pooled Placebo | Change in High Sensitivity C-reactive Protein (hsCRP) | Week 26 | 3.9 milligrams per liter (mg/L) | Standard Deviation 5.3 |
Secondary
Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta)
Change between the value of HOMA-beta cell function collected at Week 26 and HOMA-beta cell function collected at Week 0 is presented. The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 \* insulin (micro international units per milliliter (µIU/mL)) / fasting plasma glucose (millimoles per liter (mmol/L)) - 3.5. HOMA-beta score ranges from minus infinity to infinity (no limits). The higher the score the better beta-cell function for HOMA-beta. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta) | -10.7 Percentage of Beta Cell Function | Standard Deviation 94.1 |
| Cagrilintide 0.6 mg | Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta) | -20.0 Percentage of Beta Cell Function | Standard Deviation 136.9 |
| Cagrilintide 1.2 mg | Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta) | -18.3 Percentage of Beta Cell Function | Standard Deviation 89.8 |
| Cagrilintide 2.4 mg | Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta) | -29.9 Percentage of Beta Cell Function | Standard Deviation 54.8 |
| Cagrilintide 4.5 mg | Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta) | -39.7 Percentage of Beta Cell Function | Standard Deviation 101.2 |
| Liraglutide 3.0 mg | Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta) | 16.3 Percentage of Beta Cell Function | Standard Deviation 75.1 |
| Pooled Placebo | Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta) | -26.0 Percentage of Beta Cell Function | Standard Deviation 122.6 |
Secondary
Change in Low Density Lipoprotein (LDL) Cholesterol
Change in LDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Low Density Lipoprotein (LDL) Cholesterol | 5.2 mg/dL | Standard Deviation 24 |
| Cagrilintide 0.6 mg | Change in Low Density Lipoprotein (LDL) Cholesterol | -0.3 mg/dL | Standard Deviation 19.6 |
| Cagrilintide 1.2 mg | Change in Low Density Lipoprotein (LDL) Cholesterol | -0.5 mg/dL | Standard Deviation 19.8 |
| Cagrilintide 2.4 mg | Change in Low Density Lipoprotein (LDL) Cholesterol | -0.9 mg/dL | Standard Deviation 22.1 |
| Cagrilintide 4.5 mg | Change in Low Density Lipoprotein (LDL) Cholesterol | -2.7 mg/dL | Standard Deviation 19.2 |
| Liraglutide 3.0 mg | Change in Low Density Lipoprotein (LDL) Cholesterol | -5.4 mg/dL | Standard Deviation 22.9 |
| Pooled Placebo | Change in Low Density Lipoprotein (LDL) Cholesterol | -1.0 mg/dL | Standard Deviation 21.5 |
Secondary
Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity
Due to the assay development issue faced by the laboratory, the Plasminogen Activator Inhibitor-1 (PAI-1) activity (mg/L) was not performed in the study.
Time frame: From baseline (week 0) to week 26
Population: The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment.
Secondary
Change in Pulse
Change in pulse from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Time frame: From baseline (week 0) to week 26
Population: The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Pulse | -2.1 beats per minute | Standard Deviation 8.4 |
| Cagrilintide 0.6 mg | Change in Pulse | -0.6 beats per minute | Standard Deviation 8.4 |
| Cagrilintide 1.2 mg | Change in Pulse | -1.2 beats per minute | Standard Deviation 9.1 |
| Cagrilintide 2.4 mg | Change in Pulse | -2.0 beats per minute | Standard Deviation 10.2 |
| Cagrilintide 4.5 mg | Change in Pulse | -4.5 beats per minute | Standard Deviation 9.2 |
| Liraglutide 3.0 mg | Change in Pulse | 1.6 beats per minute | Standard Deviation 9.1 |
| Pooled Placebo | Change in Pulse | -0.1 beats per minute | Standard Deviation 8.5 |
Secondary
Change in Renin Activity
Change in renin activity from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Time frame: From baseline (week 0) to week 26
Population: The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Renin Activity | 2 nanograms per milliliter per hour | Standard Deviation 12 |
| Cagrilintide 0.6 mg | Change in Renin Activity | 0 nanograms per milliliter per hour | Standard Deviation 4 |
| Cagrilintide 1.2 mg | Change in Renin Activity | 1 nanograms per milliliter per hour | Standard Deviation 9 |
| Cagrilintide 2.4 mg | Change in Renin Activity | 1 nanograms per milliliter per hour | Standard Deviation 10 |
| Cagrilintide 4.5 mg | Change in Renin Activity | 1 nanograms per milliliter per hour | Standard Deviation 8 |
| Liraglutide 3.0 mg | Change in Renin Activity | 0 nanograms per milliliter per hour | Standard Deviation 5 |
| Pooled Placebo | Change in Renin Activity | 0 nanograms per milliliter per hour | Standard Deviation 5 |
Secondary
Change in Systolic Blood Pressure (SBP)
Blood pressure was measured in a sitting position after 5 minutes of rest. The end point is evaluated while the subject is treatment-adherent. A participant is treatment adherent until the first time of non-adherence defined as: a) the participant has not been dosed with trial product within the prior 14 days; b) the participant has received other weight management drug or bariatric surgery c) the participant has not reached target dose at a pre-specified week d) After the pre-specified evaluation week for the target dose, the participant has not received the target dose +/- 10 % within the prior 14 days. This endpoint is applicable only for the cagrilintide treatment arms.
Time frame: From baseline (week 0) to week 26
Population: The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Systolic Blood Pressure (SBP) | -4.9 mmHg | Standard Deviation 8.7 |
| Cagrilintide 0.6 mg | Change in Systolic Blood Pressure (SBP) | -0.9 mmHg | Standard Deviation 8.1 |
| Cagrilintide 1.2 mg | Change in Systolic Blood Pressure (SBP) | -4.9 mmHg | Standard Deviation 9.7 |
| Cagrilintide 2.4 mg | Change in Systolic Blood Pressure (SBP) | -5.0 mmHg | Standard Deviation 8.4 |
| Cagrilintide 4.5 mg | Change in Systolic Blood Pressure (SBP) | -6.2 mmHg | Standard Deviation 8.5 |
| Liraglutide 3.0 mg | Change in Systolic Blood Pressure (SBP) | -3.8 mmHg | Standard Deviation 7.1 |
Secondary
Change in Total Cholesterol
Change in total cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Total Cholesterol | 3.9 Milligrams per deciliter (mg/dL) | Standard Deviation 27.8 |
| Cagrilintide 0.6 mg | Change in Total Cholesterol | -1.8 Milligrams per deciliter (mg/dL) | Standard Deviation 22.1 |
| Cagrilintide 1.2 mg | Change in Total Cholesterol | -3.1 Milligrams per deciliter (mg/dL) | Standard Deviation 24.9 |
| Cagrilintide 2.4 mg | Change in Total Cholesterol | -2.9 Milligrams per deciliter (mg/dL) | Standard Deviation 26.7 |
| Cagrilintide 4.5 mg | Change in Total Cholesterol | -5.4 Milligrams per deciliter (mg/dL) | Standard Deviation 22.1 |
| Liraglutide 3.0 mg | Change in Total Cholesterol | -9.4 Milligrams per deciliter (mg/dL) | Standard Deviation 26.4 |
| Pooled Placebo | Change in Total Cholesterol | 0.1 Milligrams per deciliter (mg/dL) | Standard Deviation 22.8 |
Secondary
Change in Triglycerides
Change in triglycerides from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Triglycerides | -13.29 mg/dL | Standard Deviation 47.51 |
| Cagrilintide 0.6 mg | Change in Triglycerides | -16.25 mg/dL | Standard Deviation 67.59 |
| Cagrilintide 1.2 mg | Change in Triglycerides | -17.98 mg/dL | Standard Deviation 71.24 |
| Cagrilintide 2.4 mg | Change in Triglycerides | -19.24 mg/dL | Standard Deviation 47.3 |
| Cagrilintide 4.5 mg | Change in Triglycerides | -30.35 mg/dL | Standard Deviation 58.35 |
| Liraglutide 3.0 mg | Change in Triglycerides | -25.42 mg/dL | Standard Deviation 45.4 |
| Pooled Placebo | Change in Triglycerides | 8.17 mg/dL | Standard Deviation 103.36 |
Secondary
Change in Very Low Density Lipoprotein (VLDL) Cholesterol
Change in VLDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Very Low Density Lipoprotein (VLDL) Cholesterol | -2.8 mg/dL | Standard Deviation 9.1 |
| Cagrilintide 0.6 mg | Change in Very Low Density Lipoprotein (VLDL) Cholesterol | -3.4 mg/dL | Standard Deviation 11.9 |
| Cagrilintide 1.2 mg | Change in Very Low Density Lipoprotein (VLDL) Cholesterol | -3.6 mg/dL | Standard Deviation 14.1 |
| Cagrilintide 2.4 mg | Change in Very Low Density Lipoprotein (VLDL) Cholesterol | -3.8 mg/dL | Standard Deviation 9.4 |
| Cagrilintide 4.5 mg | Change in Very Low Density Lipoprotein (VLDL) Cholesterol | -5.4 mg/dL | Standard Deviation 10.2 |
| Liraglutide 3.0 mg | Change in Very Low Density Lipoprotein (VLDL) Cholesterol | -4.9 mg/dL | Standard Deviation 8.6 |
| Pooled Placebo | Change in Very Low Density Lipoprotein (VLDL) Cholesterol | 0.9 mg/dL | Standard Deviation 15.6 |
Secondary
Change in Waist Circumference
Change in waist circumference from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Change in Waist Circumference | -6.2 centimeters (cm) | Standard Deviation 5 |
| Cagrilintide 0.6 mg | Change in Waist Circumference | -6.2 centimeters (cm) | Standard Deviation 5.9 |
| Cagrilintide 1.2 mg | Change in Waist Circumference | -7.7 centimeters (cm) | Standard Deviation 7.1 |
| Cagrilintide 2.4 mg | Change in Waist Circumference | -8.1 centimeters (cm) | Standard Deviation 7.1 |
| Cagrilintide 4.5 mg | Change in Waist Circumference | -9.5 centimeters (cm) | Standard Deviation 6.1 |
| Liraglutide 3.0 mg | Change in Waist Circumference | -7.4 centimeters (cm) | Standard Deviation 5.8 |
| Pooled Placebo | Change in Waist Circumference | -3.4 centimeters (cm) | Standard Deviation 5.7 |
Secondary
Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide
Number of participants with occurrence of anti-drug antibodies towards cagrilintide from randomisation from week 0 to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. This endpoint is applicable only for the cagrilintide treatment arms.
Time frame: From week 0 to week 32
Population: The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cagrilintide 0.3 mg | Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide | 51 Participants |
| Cagrilintide 0.6 mg | Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide | 54 Participants |
| Cagrilintide 1.2 mg | Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide | 52 Participants |
| Cagrilintide 2.4 mg | Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide | 75 Participants |
| Cagrilintide 4.5 mg | Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide | 75 Participants |
Secondary
Number of Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Time frame: From week 0 to week 32
Population: The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cagrilintide 0.3 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 335 Events |
| Cagrilintide 0.6 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 291 Events |
| Cagrilintide 1.2 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 361 Events |
| Cagrilintide 2.4 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 449 Events |
| Cagrilintide 4.5 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 460 Events |
| Liraglutide 3.0 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 470 Events |
| Pooled Placebo | Number of Treatment-emergent Adverse Events (TEAEs) | 276 Events |
Secondary
Number of Treatment-emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. Serious AE is an AE that resulted in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. All SAEs reported in the below table are TESAEs. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Time frame: From week 0 to week 32
Population: The safety analysis set included all randomised participants exposed to at least one dose of randomised treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cagrilintide 0.3 mg | Number of Treatment-emergent Serious Adverse Events (TESAEs) | 8 Events |
| Cagrilintide 0.6 mg | Number of Treatment-emergent Serious Adverse Events (TESAEs) | 3 Events |
| Cagrilintide 1.2 mg | Number of Treatment-emergent Serious Adverse Events (TESAEs) | 8 Events |
| Cagrilintide 2.4 mg | Number of Treatment-emergent Serious Adverse Events (TESAEs) | 6 Events |
| Cagrilintide 4.5 mg | Number of Treatment-emergent Serious Adverse Events (TESAEs) | 4 Events |
| Liraglutide 3.0 mg | Number of Treatment-emergent Serious Adverse Events (TESAEs) | 4 Events |
| Pooled Placebo | Number of Treatment-emergent Serious Adverse Events (TESAEs) | 4 Events |
Secondary
Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Percentage change in HOMA-IR from week 0 to week 26 is presented. Insulin resistance is a condition in which cells fail to respond to normal actions of hormone in body. HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. HOMA-IR = fasting serum insulin (micro international units per milliliter (μU/ml)) × fasting plasma glucose (millimoles per liter (mmol/l)) / 22.5. HOMA-IR scores are classified as follows: less than 1.0: considered Insulin sensitive, 0.5-1.4: considered Healthy, Above 1.8: considered Early insulin resistance; Above 2.7 is considered significant insulin resistance. HOMA-IR score ranges from 0-infinity (no upper limit). Higher the score, higher the level of insulin resistance. Endpoint was evaluated based on data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in in-trial period.
Time frame: From baseline (week 0) to week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cagrilintide 0.3 mg | Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | -0.05 Percentage change of HOMA-IR | Standard Deviation 5.83 |
| Cagrilintide 0.6 mg | Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | -0.60 Percentage change of HOMA-IR | Standard Deviation 8.42 |
| Cagrilintide 1.2 mg | Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | -1.09 Percentage change of HOMA-IR | Standard Deviation 3.37 |
| Cagrilintide 2.4 mg | Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | -0.72 Percentage change of HOMA-IR | Standard Deviation 1.94 |
| Cagrilintide 4.5 mg | Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | -2.12 Percentage change of HOMA-IR | Standard Deviation 7.32 |
| Liraglutide 3.0 mg | Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | -0.91 Percentage change of HOMA-IR | Standard Deviation 2.38 |
| Pooled Placebo | Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | -0.71 Percentage change of HOMA-IR | Standard Deviation 7.1 |
Secondary
Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks
Percentage of participants who achieved a weight loss ≥ 10% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model.
Time frame: Week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cagrilintide 0.3 mg | Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks | 15.28 Percentage of participants |
| Cagrilintide 0.6 mg | Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks | 24.06 Percentage of participants |
| Cagrilintide 1.2 mg | Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks | 35.79 Percentage of participants |
| Cagrilintide 2.4 mg | Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks | 43.97 Percentage of participants |
| Cagrilintide 4.5 mg | Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks | 53.49 Percentage of participants |
| Liraglutide 3.0 mg | Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks | 39.43 Percentage of participants |
| Pooled Placebo | Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks | 10.44 Percentage of participants |
Secondary
Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks
Percentage of participants who achieved a weight loss of greater than or equal to (≥) 5% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model.
Time frame: Week 26
Population: The full analysis set included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cagrilintide 0.3 mg | Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks | 57.47 Percentage of participants |
| Cagrilintide 0.6 mg | Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks | 61.98 Percentage of participants |
| Cagrilintide 1.2 mg | Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks | 75.84 Percentage of participants |
| Cagrilintide 2.4 mg | Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks | 74.12 Percentage of participants |
| Cagrilintide 4.5 mg | Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks | 88.74 Percentage of participants |
| Liraglutide 3.0 mg | Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks | 76.16 Percentage of participants |
| Pooled Placebo | Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks | 30.90 Percentage of participants |