This study will look at how well the new medicine CagriSema helps people with excess body weight losing weight compared to a "dummy" medicine and a medicine called semaglutide. Participants will either get CagriSema, a dummy medicine or semaglutide. Which treatment participants get is decided by chance. Participants will take one injection once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
Participants will receive 2.4 mg cagrilintide subcutaneously.
Participants will receive 2.4 mg semaglutide subcutaneously.
Participants will receive placebo matched to semaglutide subcutaneously.
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
Measured in percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 5%
Measured as count of participants
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 20%
Measured as count of participants
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight
Measured in percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference
Measured in centimeter (cm)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 10%
Measured as count of participants
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 15%
Measured as count of participants
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Participants will receive placebo matched to cagrilintide subcutaneously.
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital-Endocrinology
Fuzhou, Fujian, China
Huizhou Central People's Hospital-Endocrinology
Huizhou, Guangdong, China
Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
Hengshui, Hebei, China
The Second Hospital of Hebei Medical University-Endocrinology
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Huaihe Hospital of Henan University-Endocrinology
Kaifeng, Henan, China
Huaihe Hospital of Henan University
Kaifeng, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
Luoyang, Henan, China
...and 27 more locations
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Change in waist circumference
Measured in centimeter (cm)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Glycated Haemoglobin (HbA1c)
Measured in percentage points
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Fasting Plasma Glucose (FPG)
Measured as millimole per liter (mmol/L)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in fasting serum insulin
Measured in percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Systolic Blood Pressure (SBP)
Measured in millimeter of mercury (mmHg)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Diastolic Blood Pressure (DBP)
Measured in millimeter of mercury (mmHg)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in total cholesterol
Measured in percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in high-density lipoprotein (HDL) cholesterol
Measured in percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in low-density lipoprotein (LDL) cholesterol
Measured in percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in very low-density lipoprotein (VLDL) cholesterol
Measured in percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in triglycerides
Measured in percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in free fatty acids
Measured in percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Short Form-36 Version 2.0 (SF- 36v2) Physical Functioning score
Measured as score points. The SF-36v2.0 is a 36-item commonly used generic clinical outcome assessment (COA) instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'physical functioning domain'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 correspond to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Physical Component Summary Score
Measured as score points. The SF-36v2.0 is a 36-item commonly used generic COA instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'physical component summary'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Mental Component Summary score
Measured as score points. The SF-36v2.0 is a 36-item commonly used generic COA instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'mental component summary'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOLLite- 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 patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. This endpoint assess the 'physical function score'. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline.
Time frame: From baseline (week 0) to end of treatment (week 44)
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 patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. This endpoint assess the 'total score'. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline.
Time frame: From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Adverse Events (TEAEs)
Measured as count of events
Time frame: From baseline (week 0) to end of study (week 51)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Serious Adverse Events (TESAEs)
Measured as count of events
Time frame: From baseline (week 0) to end of study (week 51)
Number of clinically significant hypoglycaemic episodes (level 2) (lesser than 3.0 mmol/L (54 milligrams per deciliter[mg/dL]), confirmed by BG meter) (only for participants with Type 2 diabetes (T2D) at screening)
Measured as count of episodes
Time frame: From baseline (week 0) to end of study (week 51)
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold (only for participants with T2D at screening)
Measured as count of episodes
Time frame: From baseline (week 0) to end of study (week 51)