A Phase 2 interventional study of NNC0174-0833 and Placebo (NNC0174-0833) in Overweight and Obesity, sponsored by Novo Nordisk A/S. Completed at 54 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment
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.
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Exclusion Criteria:
Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks.
Drug: NNC0174-0833
Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks.
Drug: NNC0174-0833
Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks.
Drug: NNC0174-0833
Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks.
Drug: NNC0174-0833
Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.
Drug: NNC0174-0833
Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
Drug: Placebo (NNC0174-0833)
Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
Drug: Placebo (NNC0174-0833)
Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
Drug: Placebo (NNC0174-0833)
Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.
Drug: Placebo (NNC0174-0833)
Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.
Drug: Placebo (NNC0174-0833)
Patients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks.
Drug: Liraglutide 3.0 mg
Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks.
Drug: Placebo (Liraglutide 3.0 mg)
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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).
| Milestone | 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 |
|---|---|---|---|---|---|---|---|
| Started | 101 | 100 | 102 | 102 | 101 | 99 | 101 |
| Full analysis set | 101 | 100 | 102 | 102 | 101 | 99 | 101 |
| Safety analysis set | 101 | 100 | 102 | 102 | 101 | 99 | 101 |
| Completed | 97 | 97 | 98 | 101 | 94 | 95 | 95 |
| Not completed | 4 | 3 | 4 | 1 | 7 | 4 | 6 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 | 0 | 3 | 0 | 2 |
| Withdrew: Lost to follow-up | 4 | 2 | 3 | 1 | 4 | 4 | 4 |
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.
| Percentage point of body weight | 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 |
|---|---|---|---|---|---|---|---|
| Change in Body Weight (%) | -6.1 ± 3.9 | -6.9 ± 5.4 | -8.5 ± 5.4 | -9.5 ± 6.2 | -10.8 ± 5.5 | -8.5 ± 5.6 | -3.0 ± 5.2 |
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 of participants | 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 |
|---|---|---|---|---|---|---|---|
| Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks | 57.47 | 61.98 | 75.84 | 74.12 | 88.74 | 76.16 | 30.90 |
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.
| Percentage of participants | 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 |
|---|---|---|---|---|---|---|---|
| Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks | 15.28 | 24.06 | 35.79 | 43.97 | 53.49 | 39.43 | 10.44 |
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.
| Kilograms (kg) | 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 |
|---|---|---|---|---|---|---|---|
| Change in Body Weight (Kg) | -6.6 ± 4.3 | -7.1 ± 5.6 | -9.0 ± 6.3 | -10.1 ± 6.7 | -11.8 ± 6.8 | -9.1 ± 6.4 | -3.2 ± 5.8 |
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.
| centimeters (cm) | 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 |
|---|---|---|---|---|---|---|---|
| Change in Waist Circumference | -6.2 ± 5.0 | -6.2 ± 5.9 | -7.7 ± 7.1 | -8.1 ± 7.1 | -9.5 ± 6.1 | -7.4 ± 5.8 | -3.4 ± 5.7 |
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.
| Milligrams per deciliter (mg/dL) | 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 |
|---|---|---|---|---|---|---|---|
| Change in Total Cholesterol | 3.9 ± 27.8 | -1.8 ± 22.1 | -3.1 ± 24.9 | -2.9 ± 26.7 | -5.4 ± 22.1 | -9.4 ± 26.4 | 0.1 ± 22.8 |
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.
| mg/dL | 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 |
|---|---|---|---|---|---|---|---|
| Change in High Density Lipoprotein (HDL) Cholesterol | 1.5 ± 6.1 | 1.9 ± 6.9 | 1.1 ± 7.3 | 1.8 ± 5.6 | 2.6 ± 6.9 | 0.8 ± 6.3 | 0.1 ± 7.0 |
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.
| mg/dL | 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 |
|---|---|---|---|---|---|---|---|
| Change in Low Density Lipoprotein (LDL) Cholesterol | 5.2 ± 24.0 | -0.3 ± 19.6 | -0.5 ± 19.8 | -0.9 ± 22.1 | -2.7 ± 19.2 | -5.4 ± 22.9 | -1.0 ± 21.5 |
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.
| mg/dL | 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 |
|---|---|---|---|---|---|---|---|
| Change in Very Low Density Lipoprotein (VLDL) Cholesterol | -2.8 ± 9.1 | -3.4 ± 11.9 | -3.6 ± 14.1 | -3.8 ± 9.4 | -5.4 ± 10.2 | -4.9 ± 8.6 | 0.9 ± 15.6 |
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.
| mg/dL | 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 |
|---|---|---|---|---|---|---|---|
| Change in Triglycerides | -13.29 ± 47.51 | -16.25 ± 67.59 | -17.98 ± 71.24 | -19.24 ± 47.30 | -30.35 ± 58.35 | -25.42 ± 45.40 | 8.17 ± 103.36 |
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.
| Percentage point of HbA1c | 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 |
|---|---|---|---|---|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) (%-Point) | 0.0 ± 0.2 | -0.1 ± 0.2 | -0.1 ± 0.3 | -0.1 ± 0.3 | -0.1 ± 0.2 | -0.3 ± 0.2 | -0.1 ± 0.2 |
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.
| mmol/mol | 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 |
|---|---|---|---|---|---|---|---|
| Change in HbA1c (mmol/Mol) | -0.5 ± 2.4 | -0.6 ± 2.2 | -0.8 ± 3.0 | -1.0 ± 2.9 | -1.2 ± 2.4 | -2.9 ± 2.7 | -0.6 ± 2.7 |
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.
| mmol/L | 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 |
|---|---|---|---|---|---|---|---|
| Change in Fasting Plasma Glucose (FPG) (mmol/L) | 0.0 ± 0.6 | 0.0 ± 0.5 | -0.2 ± 0.5 | 0.0 ± 0.7 | -0.2 ± 1.0 | -0.5 ± 0.7 | 0.0 ± 0.6 |
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.
| mg/dL | 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 |
|---|---|---|---|---|---|---|---|
| Change in FPG (mg/dL) | -0.7 ± 10.1 | -0.6 ± 8.9 | -3.2 ± 9.7 | 0.0 ± 12.0 | -3.7 ± 18.4 | -9.5 ± 12.4 | -0.5 ± 11.7 |
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.
| Picomoles per liter (pmol/L) | 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 |
|---|---|---|---|---|---|---|---|
| Week 0 | 103.88 ± 6.62 | 97.43 ± 6.73 | 96.44 ± 5.91 | 90.05 ± 4.70 | 109.99 ± 8.23 | 95.80 ± 5.73 | 105.77 ± 7.06 |
| Week 26 | 93.07 ± 6.44 | 82.98 ± 5.02 | 79.39 ± 4.53 | 71.22 ± 4.04 | 78.67 ± 5.42 | 79.00 ± 5.46 | 86.55 ± 5.59 |
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.
| Percentage change of HOMA-IR | 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 |
|---|---|---|---|---|---|---|---|
| Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | -0.05 ± 5.83 | -0.60 ± 8.42 | -1.09 ± 3.37 | -0.72 ± 1.94 | -2.12 ± 7.32 | -0.91 ± 2.38 | -0.71 ± 7.10 |
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.
| Percentage of Beta Cell Function | 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 |
|---|---|---|---|---|---|---|---|
| Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta) | -10.7 ± 94.1 | -20.0 ± 136.9 | -18.3 ± 89.8 | -29.9 ± 54.8 | -39.7 ± 101.2 | 16.3 ± 75.1 | -26.0 ± 122.6 |
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.
| Events | 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 |
|---|---|---|---|---|---|---|---|
| Number of Treatment-emergent Adverse Events (TEAEs) | 335 | 291 | 361 | 449 | 460 | 470 | 276 |
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.
| Events | 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 |
|---|---|---|---|---|---|---|---|
| Number of Treatment-emergent Serious Adverse Events (TESAEs) | 8 | 3 | 8 | 6 | 4 | 4 | 4 |
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.
| Participants | Cagrilintide 0.3 mg | Cagrilintide 0.6 mg | Cagrilintide 1.2 mg | Cagrilintide 2.4 mg | Cagrilintide 4.5 mg |
|---|---|---|---|---|---|
| Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide | 51 | 54 | 52 | 75 | 75 |
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.
| millimeter of mercury (mmHg) | Cagrilintide 0.3 mg | Cagrilintide 0.6 mg | Cagrilintide 1.2 mg | Cagrilintide 2.4 mg | Cagrilintide 4.5 mg | Pooled Placebo |
|---|---|---|---|---|---|---|
| Change in Diastolic Blood Pressure (DBP) | -2.2 ± 5.9 | 0.8 ± 5.0 | -1.3 ± 6.0 | -1.2 ± 5.5 | -1.8 ± 6.3 | -2.6 ± 5.5 |
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.
| mmHg | Cagrilintide 0.3 mg | Cagrilintide 0.6 mg | Cagrilintide 1.2 mg | Cagrilintide 2.4 mg | Cagrilintide 4.5 mg | Pooled Placebo |
|---|---|---|---|---|---|---|
| Change in Systolic Blood Pressure (SBP) | -4.9 ± 8.7 | -0.9 ± 8.1 | -4.9 ± 9.7 | -5.0 ± 8.4 | -6.2 ± 8.5 | -3.8 ± 7.1 |
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.
| beats per minute | 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 |
|---|---|---|---|---|---|---|---|
| Change in Pulse | -2.1 ± 8.4 | -0.6 ± 8.4 | -1.2 ± 9.1 | -2.0 ± 10.2 | -4.5 ± 9.2 | 1.6 ± 9.1 | -0.1 ± 8.5 |
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.
| milligrams per liter (mg/L) | 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 |
|---|---|---|---|---|---|---|---|
| Week 0 | 4.5 ± 6.7 | 4.6 ± 3.9 | 4.5 ± 5.8 | 5.8 ± 7.2 | 5.4 ± 7.5 | 4.7 ± 4.1 | 4.6 ± 6.0 |
| Week 26 | 3.5 ± 3.5 | 3.4 ± 3.0 | 4.6 ± 8.8 | 4.0 ± 5.5 | 3.4 ± 4.0 | 3.5 ± 3.4 | 3.9 ± 5.3 |
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.
No measurements were reported for this outcome.
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.
| nanograms per milliliter per hour | 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 |
|---|---|---|---|---|---|---|---|
| Change in Renin Activity | 2 ± 12 | 0 ± 4 | 1 ± 9 | 1 ± 10 | 1 ± 8 | 0 ± 5 | 0 ± 5 |
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.
| nanograms per deciliter (ng/dL) | 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 |
|---|---|---|---|---|---|---|---|
| Change in Aldosterone | 0.8 ± 5.4 | 0.8 ± 6.3 | 0.7 ± 5.2 | 2.2 ± 7.1 | 1.1 ± 5.9 | 1.0 ± 8.2 | 0.5 ± 5.1 |
Collected over From week 0 to week 32 Results are based on the safety analysis set which included all randomised participants exposed to at least one dose of randomised treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cagrilintide 0.3 mg | 0/101 (0%) | 6/101 (5.9%) | 59/101 (58.4%) |
| Cagrilintide 0.6 mg | 0/100 (0%) | 2/100 (2%) | 58/100 (58%) |
| Cagrilintide 1.2 mg | 0/102 (0%) | 7/102 (6.9%) | 72/102 (70.6%) |
| Cagrilintide 2.4 mg | 0/102 (0%) | 3/102 (2.9%) | 62/102 (60.8%) |
| Cagrilintide 4.5 mg | 0/101 (0%) | 4/101 (4%) | 76/101 (75.2%) |
| Liraglutide 3.0 mg | 0/99 (0%) | 4/99 (4%) | 65/99 (65.7%) |
| Placebo Pool | 0/101 (0%) | 3/101 (3%) | 45/101 (44.6%) |
| Event | Cagrilintide 0.3 mg | Cagrilintide 0.6 mg | Cagrilintide 1.2 mg | Cagrilintide 2.4 mg | Cagrilintide 4.5 mg | Liraglutide 3.0 mg | Placebo Pool |
|---|---|---|---|---|---|---|---|
| Non-cardiac chest painGeneral disorders | 0/101 | 0/100 | 0/102 | 0/102 | 0/101 | 0/99 | 2/101 |
| CholelithiasisHepatobiliary disorders | 0/101 | 0/100 | 0/102 | 0/102 | 1/101 | 1/99 | 0/101 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 0/101 | 0/100 | 0/102 | 0/102 | 0/101 | 1/99 | 0/101 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/101 | 0/100 | 0/102 | 0/102 | 0/101 | 1/99 | 0/101 |
| Transient ischaemic attackNervous system disorders | 0/101 | 0/100 | 0/102 | 0/102 | 0/101 | 1/99 | 0/101 |
| Ligament injuryInjury, poisoning and procedural complications | 0/101 | 1/100 | 0/102 | 0/102 | 0/101 | 0/99 | 0/101 |
| Meniscus injuryInjury, poisoning and procedural complications | 0/101 | 1/100 | 0/102 | 0/102 | 0/101 | 0/99 | 0/101 |
| Rectal adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/101 | 1/100 | 0/102 | 0/102 | 0/101 | 0/99 | 0/101 |
| Arthritis bacterialInfections and infestations | 0/101 | 0/100 | 0/102 | 0/102 | 1/101 | 0/99 | 0/101 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/101 | 0/100 | 0/102 | 0/102 | 0/101 | 0/99 | 0/101 |
| Event | Cagrilintide 0.3 mg | Cagrilintide 0.6 mg | Cagrilintide 1.2 mg | Cagrilintide 2.4 mg | Cagrilintide 4.5 mg | Liraglutide 3.0 mg | Placebo Pool |
|---|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 20/101 | 27/100 | 37/102 | 32/102 | 47/101 | 39/99 | 18/101 |
| ConstipationGastrointestinal disorders | 11/101 | 9/100 | 8/102 | 17/102 | 21/101 | 26/99 | 7/101 |
| VomitingGastrointestinal disorders | 6/101 | 6/100 | 5/102 | 9/102 | 8/101 | 20/99 | 3/101 |
| FatigueGeneral disorders | 8/101 | 5/100 | 8/102 | 10/102 | 20/101 | 8/99 | 3/101 |
| DiarrhoeaGastrointestinal disorders | 15/101 | 10/100 | 8/102 | 18/102 | 7/101 | 18/99 | 9/101 |
| Decreased appetiteMetabolism and nutrition disorders | 4/101 | 9/100 | 8/102 | 13/102 | 17/101 | 9/99 | 4/101 |
| Injection site erythemaGeneral disorders | 5/101 | 4/100 | 6/102 | 7/102 | 17/101 | 3/99 | 0/101 |
| HeadacheNervous system disorders | 10/101 | 5/100 | 11/102 | 11/102 | 7/101 | 13/99 | 12/101 |
| NasopharyngitisInfections and infestations | 6/101 | 9/100 | 13/102 | 4/102 | 3/101 | 10/99 | 10/101 |
| Injection site reactionGeneral disorders | 4/101 | 4/100 | 7/102 | 12/102 | 10/101 | 1/99 | 0/101 |
The full analysis set included all randomised participants according to the intention-to-treat principle.
| Age, Continuous(Years) | 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 |
|---|---|---|---|---|---|---|---|---|
| Mean | 53.5 ± 10.3 | 53.2 ± 11.0 | 52.1 ± 8.7 | 52.7 ± 9.8 | 51.5 ± 12.7 | 51.5 ± 9.3 | 51.4 ± 11.9 | 52.3 ± 10.6 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|---|---|---|---|
| Female | 56 | 62 | 63 | 75 | 56 | 65 | 59 | 436 |
| Male | 45 | 38 | 39 | 27 | 45 | 34 | 42 | 270 |
| Ethnicity (NIH/OMB)(Participants) | 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 |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 4 | 2 | 3 | 5 | 4 | 21 |
| Not Hispanic or Latino | 99 | 99 | 98 | 100 | 98 | 94 | 97 | 685 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | 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 |
|---|---|---|---|---|---|---|---|---|
| White | 77 | 75 | 75 | 80 | 83 | 82 | 71 | 543 |
| Asian | 13 | 14 | 15 | 11 | 9 | 13 | 17 | 92 |
| Black or African American | 9 | 5 | 8 | 9 | 5 | 0 | 9 | 45 |
| American Indian or Alaska Native | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 2 |
| Other | 1 | 5 | 4 | 2 | 4 | 4 | 4 | 24 |
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Studies of the drug tested here: Cagrilintide