Obesity
Conditions
Brief summary
This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms. Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.
Interventions
DRUGCagrilintide
Cagrilintide will be administered subcutaneously.
DRUGSemaglutide
Participants will recieve semaglutide subcutaneously.
Participants will receive placebo matched to cagrilintide.
Participants will receive placebo matched to semaglutide.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or female * Age above or equal to 18 years at the time of signing informed consent * Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m\^2) or b) BMI greater than or equal to 27.0 kg/m\^2 with the presence of at least one weight-related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
Exclusion criteria
\- Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening b) History of type 1 or type 2 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CagriSema versus placebo: Relative change in body weight | From baseline (week 0) to end of treatment (week 68) | Measured in percentage (%) |
| CagriSema versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction | From baseline (week 0) to end of treatment (week 68) | Measured as count of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in COEQ: Craving for Sweets Score | From baseline (week 0) to end of treatment (week 68) | Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). |
| Change in COEQ: Positive Mood score | From baseline (week 0) to end of treatment (week 68) | Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). |
| CagriSema versus placebo: Achievement of >= 20% weight reduction | From baseline (week 0) to end of treatment (week 68) | Measured as count of participant |
| CagriSema versus placebo: Achievement of >= 25% weight reduction | From baseline (week 0) to end of treatment (week 68) | Measured as count of participant |
| CagriSema versus placebo: Achievement of >= 30% weight reduction | From baseline (week 0) to end of treatment (week 68) | Measured as count of participant |
| CagriSema versus cagrilintide and CagriSema versus semaglutide: Relative change in body weight | From baseline (week 0) to end of treatment (week 68) | Measured as percentage (%) |
| CagriSema versus placebo: Relative change in body weight | From baseline (week 0) to week 8 | Measured as percentage (%) |
| CagriSema versus placebo: Change in waist circumference | From baseline (week 0) to end of treatment (week 68) | Measured in centimeters (cm) |
| CagriSema versus placebo: Change in systolic blood pressure (SBP) | From baseline (week 0) to end of treatment (week 68) | Measured in millimeters of mercury (mmHg) |
| CagriSema versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score | From baseline (week 0) to end of treatment (week 68) | Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. |
| CagriSema versus placebo: Change in SF-v2 Health Survey Acute (SF-36 v2 Acute) Physical Functioning Score | From baseline (week 0) to end of treatment (week 68) | Measured as score points. The SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. |
| CagriSema versus placebo, semaglutide and cagrilintide: Change in body weight | From baseline (week 0) to end of treatment (week 68) | Measured in kilograms (kg) |
| CagriSema versus placebo, semalutide and cagrilintide: Change in body mass index (BMI) | From baseline (week 0) to end of treatment (week 68) | Measured in kilogram per square meter (kg/m\^2) |
| CagriSema versus placebo, semaglutide and cagrilintide: Improvement in weight category | From baseline (week 0) to end of treatment (week 68) | Measured as count of participants. The categories are: BMI, underweight less than (\<) 18.5, normal weight 18.5 to \<25, overweight 25.0 to \<30, obesity class I 30 to \< 35, obesity class II 35 to \< 40, obesity class III \>40. |
| CagriSema versus placebo: Change in Glycated Haemoglobin (HbA1c) | From baseline (week 0) to end of treatment (week 68) | Measured as percentage (%) |
| CagriSema versus placebo: Change in HbA1c | From baseline (week 0) to end of treatment (week 68) | Measured as millimoles per mole (mmol/mol). |
| CagriSema versus placebo: Change in Fasting Plasma Glucose (FPG) (mmol/L). | From baseline (week 0) to end of treatment (week 68) | Measured as millimoles per liter (mmol/L). |
| CagriSema versus placebo: Change in FPG (mg/dL) | From baseline (week 0) to end of treatment (week 68) | Measured as milligrams per deciliter (mg/dL). |
| CagriSema versus placebo: Ratio to baseline in fasting serum insulin | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| CagriSema versus placebo: Change in Diastolic Blood Pressure (DBP) | From baseline (week 0) to end of treatment (week 68) | Measured in mmHg |
| CagriSema versus placebo: Ratio to baseline in total cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| CagriSema versus placebo: Ratio to baseline in High-density lipoprotein (HDL) cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| CagriSema versus placebo: Ratio to baseline in Low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| CagriSema versus placebo: Ratio to baseline in Very low-density lipoprotein (VLDL) cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| CagriSema versus placebo: Ratio to baseline in Triglycerides | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| CagriSema versus placebo: Ratio to baseline in Free fatty acids | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| CagriSema versus semaglutide and cagrilintide: Change in waist circumference | From baseline (week 0) to end of treatment (week 68) | Measured in centimeters (cm) |
| CagriSema versus semaglutide and cagrilintide: Change in SBP | From baseline (week 0) to end of treatment (week 68) | Measured in mmHg |
| CagriSema versus semaglutide and cagrilintide: Ratio to baseline in total cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| CagriSema versus semaglutide and cagrilintide: Ratio to baseline in HDL | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| CagriSema versus semaglutide and cagrilintide: Ratio to baseline in LDL | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| CagriSema versus semaglutide and cagrilintide: Ratio to baseline in VLDL | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| CagriSema versus semaglutide and cagrilintide: Ratio to baseline in Triglycerides | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| CagriSema versus semaglutide and cagrilintide: Ratio to baseline in Free fatty acids | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| CagriSema versus placebo: Relative change in body weight (Measured in kilograms (kg)) | From baseline (week 0) to end of treatment (week 68) | Measured in kilograms (kg). |
| CagriSema versus placebo: Relative change in body weight (Measured in percentage (%)) | From baseline (week 0) to end of treatment (week 68) | Measured in percentage (%). |
| CagriSema versus placebo: Absolute change in body weight (Measured in kilograms (kg)) | From baseline (week 0) to end of treatment (week 68) | Measured in kilograms (kg). |
| CagriSema versus placebo: Absolute change in body weight (Measured in percentage (%)) | From baseline (week 0) to end of treatment (week 68) | Measured in percentage (%). |
| CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as kilograms (kg)) | From baseline (week 0) to end of treatment (week 68) | Measured as kilograms (kg) |
| CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as percentage (%)) | From baseline (week 0) to end of treatment (week 68) | Measured as percentage (%) |
| CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as kilograms (kg)) | From baseline (week 0) to end of treatment (week 68) | Measured as kilograms (kg) |
| CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as percentage (%)) | From baseline (week 0) to end of treatment (week 68) | Measured as percentage (%) |
| CagriSema versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as percentage (%)) | From baseline (week 0) to end of treatment (week 68) | Measured as percentage (%) |
| CagriSema versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as %-points) | From baseline (week 0) to end of treatment (week 68) | Measured as %-points |
| CagriSema versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as percentage (%)) | From baseline (week 0) to end of treatment (week 68) | Measured as percentage (%). |
| CagriSema versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as %-points) | From baseline (week 0) to end of treatment (week 68) | Measured as %-points |
| CagriSema versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in kilograms (kg)) | From baseline (week 0) to end of treatment (week 68) | Measured in kilograms (kg) |
| CagriSema versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in percentage (%)) | From baseline (week 0) to end of treatment (week 68) | Measured in percentage (%) |
| CagriSema versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in kilograms (kg)) | From baseline (week 0) to end of treatment (week 68) | Measured in kilograms (kg) |
| CagriSema versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in percentage (%)) | From baseline (week 0) to end of treatment (week 68) | Measured in percentage (%) |
| CagriSema versus placebo: Achievement of at least 14.6- point increase (yes/no) in IWQOL-Lite-CT Physical Function score | From baseline (week 0) to end of treatment (week 68) | Measured as count of participants. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. |
| CagriSema versus placebo: Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Physical Functioning score | From baseline (week 0) to end of treatment (week 68) | Measured as count of participants. The SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. |
| CagriSema versus placebo: Change in IWQOL-Lite-CT - Physical Function Score | From baseline (week 0) to end of treatment (week 68) | Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. |
| CagriSema versus placebo: Change in IWQOL-Lite-CT - Psychosocial Score | From baseline (week 0) to end of treatment (week 68) | Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. |
| CagriSema versus placebo: Change in IWQOL-Lite-CT - Total Score | From baseline (week 0) to end of treatment (week 68) | Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. |
| Change in Control of Eating (COEQ): Craving Control Score | From baseline (week 0) to end of treatment (week 68) | Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). |
| Change in COEQ: Satiety score | From baseline (week 0) to end of treatment (week 68) | Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). |
| CagriSema versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Change in IWQOL-Lite-CT Physical Function score | From baseline (week 0) to end of treatment (week 68) | Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. |
| CagriSema versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score | From baseline (week 0) to end of treatment (week 68) | Measured as count of participants. |
| CagriSema versus placebo, semalutide and cagrilintide: Ratio to baseline C-reactive protein (CRP) | From baseline (week 0) to end of treatment (week 68) | Measured as ratio |
| Number of Treatment Emergent Adverse Events (TEAEs) | From baseline (week 0) to end of study-main part (week 75) | Measured as count of events |
| Change in COEQ: Craving for Savoury food score | From baseline (week 0) to end of treatment (week 68) | Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). |
| Number of Treatment Emergent Serious adverse events (TESAEs) | From baseline (week 0) to end of study-main part (week 75) | Measured as count of events. |
| Change in COEQ: Hunger score | From baseline (week 0) to end of treatment (week 68) | Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). |
Countries
Argentina, Australia, Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, India, Italy, Japan, Mexico, Netherlands, Poland, Serbia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed