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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3,400
Cagrilintide will be administered subcutaneously.
Participants will recieve semaglutide subcutaneously.
Participants will receive placebo matched to cagrilintide.
Participants will receive placebo matched to semaglutide.
Univ of Alabama Birmingham
Birmingham, Alabama, United States
Velocity Clin Res Los Angeles
Los Angeles, California, United States
Velocity Clin Res Wstlke
Los Angeles, California, United States
Univ of Colorado at Denver
Aurora, Colorado, United States
OptumCare Clinical Trials LLC
Golden, Colorado, United States
CagriSema versus placebo: Relative change in body weight
Measured in percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction
Measured as count of participants
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Achievement of >= 20% weight reduction
Measured as count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Achievement of >= 25% weight reduction
Measured as count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Achievement of >= 30% weight reduction
Measured as count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus cagrilintide and CagriSema versus semaglutide: Relative change in body weight
Measured as percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Relative change in body weight
Measured as percentage (%)
Time frame: From baseline (week 0) to week 8
CagriSema versus placebo: Relative change in body weight
Measured as percentage (%)
Time frame: From baseline (week 0) to week 20
CagriSema versus placebo: Change in waist circumference
Measured in centimeters (cm)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in systolic blood pressure (SBP)
Measured in millimeters of mercury (mmHg)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score
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.
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in SF-v2 Health Survey Acute (SF-36 v2 Acute) Physical Functioning Score
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.
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo, semaglutide and cagrilintide: Change in body weight
Measured in kilograms (kg)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo, semalutide and cagrilintide: Change in body mass index (BMI)
Measured in kilogram per square meter (kg/m\^2)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo, semaglutide and cagrilintide: Improvement in weight category
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.
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in Glycated Haemoglobin (HbA1c)
Measured as percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in HbA1c
Measured as millimoles per mole (mmol/mol).
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in Fasting Plasma Glucose (FPG) (mmol/L).
Measured as millimoles per liter (mmol/L).
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in FPG (mg/dL)
Measured as milligrams per deciliter (mg/dL).
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Ratio to baseline in fasting serum insulin
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in Diastolic Blood Pressure (DBP)
Measured in mmHg
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Ratio to baseline in total cholesterol
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Ratio to baseline in High-density lipoprotein (HDL) cholesterol
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Ratio to baseline in Low-density lipoprotein (LDL) cholesterol
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Ratio to baseline in Very low-density lipoprotein (VLDL) cholesterol
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Ratio to baseline in Triglycerides
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Ratio to baseline in Free fatty acids
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide and cagrilintide: Change in waist circumference
Measured in centimeters (cm)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide and cagrilintide: Change in SBP
Measured in mmHg
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide and cagrilintide: Ratio to baseline in total cholesterol
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide and cagrilintide: Ratio to baseline in HDL
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide and cagrilintide: Ratio to baseline in LDL
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide and cagrilintide: Ratio to baseline in VLDL
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide and cagrilintide: Ratio to baseline in Triglycerides
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide and cagrilintide: Ratio to baseline in Free fatty acids
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Relative change in body weight (Measured in kilograms (kg))
Measured in kilograms (kg).
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Relative change in body weight (Measured in percentage (%))
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Absolute change in body weight (Measured in kilograms (kg))
Measured in kilograms (kg).
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Absolute change in body weight (Measured in percentage (%))
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 68)
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))
Measured as kilograms (kg)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as percentage (%))
Measured as percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 68)
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))
Measured as kilograms (kg)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as percentage (%))
Measured as percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as percentage (%))
Measured as percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as %-points)
Measured as %-points
Time frame: From baseline (week 0) to end of treatment (week 68)
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 (%))
Measured as percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 68)
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)
Measured as %-points
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in kilograms (kg))
Measured in kilograms (kg)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in percentage (%))
Measured in percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in kilograms (kg))
Measured in kilograms (kg)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in percentage (%))
Measured in percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Achievement of at least 14.6- point increase (yes/no) in IWQOL-Lite-CT Physical Function score
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.
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Physical Functioning score
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.
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in IWQOL-Lite-CT - Physical Function Score
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.
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in IWQOL-Lite-CT - Psychosocial Score
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.
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Change in IWQOL-Lite-CT - Total Score
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.
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in Control of Eating (COEQ): Craving Control Score
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).
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in COEQ: Craving for Savoury food score
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).
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in COEQ: Hunger score
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).
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in COEQ: Craving for Sweets Score
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).
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in COEQ: Positive Mood score
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).
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in COEQ: Satiety score
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).
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Change in IWQOL-Lite-CT Physical Function score
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.
Time frame: From baseline (week 0) to end of treatment (week 68)
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
Measured as count of participants.
Time frame: From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo, semalutide and cagrilintide: Ratio to baseline C-reactive protein (CRP)
Measured as ratio
Time frame: From baseline (week 0) to end of treatment (week 68)
Number of Treatment Emergent Adverse Events (TEAEs)
Measured as count of events
Time frame: From baseline (week 0) to end of study-main part (week 75)
Number of Treatment Emergent Serious adverse events (TESAEs)
Measured as count of events.
Time frame: From baseline (week 0) to end of study-main part (week 75)
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