Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight |
Measured in percentage (%) |
From baseline (week 0) to end of treatment (week 68) |
|
| Primary |
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction |
Measured as count of participants |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 20% weight reduction |
Measured as count of participant |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 25% weight reduction |
Measured as count of participant |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Achievement of >= 30% weight reduction |
Measured as count of participant |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg; and CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight |
Measured as percentage (%) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 0.5 mg/0.5 mg versus placebo: Relative change in body weight |
Measured as percentage (%) |
From baseline (week 0) to week 8 |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight |
Measured as percentage (%) |
From baseline (week 0) to week 20 |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference |
Measured in centimeters (cm) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Change in systolic blood pressure (SBP) |
Measured in millimeters of mercury (mmHg) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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. |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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. |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo, semaglutide 2.4 mg and cagrilintide 2.4 mg: Change in body weight |
Measured in kilograms (kg) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo, semalutide 2.4 mg and cagrilintide 2.4 mg: Change in body mass index (BMI) |
Measured in kilogram per square meter (kg/m^2) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo, semaglutide 2.4 mg and cagrilintide 2.4 mg: 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. |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Glycated Haemoglobin (HbA1c) |
Measured as percentage (%) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Change in HbA1c |
Measured as millimoles per mole (mmol/mol). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Fasting Plasma Glucose (FPG) |
Measured as millimoles per liter (mmol/L). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Change in FPG |
Measured as milligrams per deciliter (mg/dL). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in fasting serum insulin |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Diastolic Blood Pressure (DBP) |
Measured in mmHg |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in total cholesterol |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in High-density lipoprotein (HDL) cholesterol |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in Low-density lipoprotein (LDL) cholesterol |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in Very low-density lipoprotein (VLDL) cholesterol |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in Triglycerides |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Ratio to baseline in Free fatty acids |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Change in waist circumference |
Measured in centimeters (cm) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Change in SBP |
Measured in mmHg |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in total cholesterol |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in HDL |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in LDL |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in VLDL |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in Triglycerides |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline in Free fatty acids |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight (Measured in kilograms (kg)) |
Measured in kilograms (kg). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight (Measured in percentage (%)) |
Measured in percentage (%). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Absolute change in body weight (Measured in kilograms (kg)) |
Measured in kilograms (kg). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Absolute change in body weight (Measured in percentage (%)) |
Measured in percentage (%). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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 (%) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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 (%) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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 (%) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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 |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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 (%). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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 |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in kilograms (kg)) |
Measured in kilograms (kg) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in percentage (%)) |
Measured in percentage (%) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in kilograms (kg)) |
Measured in kilograms (kg) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in percentage (%)) |
Measured in percentage (%) |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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. |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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. |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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. |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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. |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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. |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
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). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
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). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
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). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
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). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
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). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
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). |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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. |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg 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. |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
CagriSema 2.4 mg/2.4 mg versus placebo, semalutide 2.4 mg and cagrilintide 2.4 mg: Ratio to baseline C-reactive protein (CRP) |
Measured as ratio |
From baseline (week 0) to end of treatment (week 68) |
|
| Secondary |
Number of Treatment Emergent Adverse Events (TEAEs) |
Measured as count of events |
From baseline (week 0) to end of study-main part (week 75) |
|
| Secondary |
Number of Treatment Emergent Serious adverse events (TESAEs) |
Measured as count of events. |
From baseline (week 0) to end of study-main part (week 75) |
|
