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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1267-4364 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CagriSema | Experimental | Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks. |
|
| Semaglutide | Active Comparator | Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks. |
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| Placebo | Placebo Comparator | Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide | Drug | Participants will receive 2.4 mg cagrilintide subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 | From baseline (week 0) to end of treatment (week 44) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Male or female
Age above or equal to 18 years at the time of signing informed consent
For participants with Type 2 diabetes (T2D) at screening the following criteria also apply:
Exclusion Criteria:
For participants without T2D at screening:
For participants with T2D at screening:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Office (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese People's Liberation Army General Hospital-Endocrinology | Beijing | Beijing Municipality | 100853 | China | ||
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Semaglutide |
| Drug |
Participants will receive 2.4 mg semaglutide subcutaneously. |
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| Placebo Semaglutide | Drug | Participants will receive placebo matched to semaglutide subcutaneously. |
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| Placebo Cagrilintide | Drug | Participants will receive placebo matched to cagrilintide subcutaneously. |
|
Measured in percentage (%) |
| 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) | 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 | 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 | 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) | 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 | 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) | 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 (%) | 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) | 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) | 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 (%) | 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 (%) | 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 (%) | 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 (%) | 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 (%) | 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 (%) | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | From baseline (week 0) to end of study (week 51) |
| Chongqing University Three Gorges Hospital |
| Chongqing |
| Chongqing Municipality |
| 404000 |
| China |
| Fujian Medical University Union Hospital-Endocrinology | Fuzhou | Fujian | 350001 | China |
| Huizhou Central People's Hospital-Endocrinology | Huizhou | Guangdong | 516001 | China |
| Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology | Hengshui | Hebei | 053000 | China |
| The Second Hospital of Hebei Medical University-Endocrinology | Shijiazhuang | Hebei | 050000 | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| Huaihe Hospital of Henan University-Endocrinology | Kaifeng | Henan | 475000 | China |
| Huaihe Hospital of Henan University | Kaifeng | Henan | 475000 | China |
| The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology | Luoyang | Henan | 471003 | China |
| The First Affiliated Hospital of Henan university of Science | Luoyang | Henan | 471003 | China |
| The Second Affiliated Hospital of Zhengzhou University-Endocrinology | Zhengzhou | Henan | 450003 | China |
| The Second Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450003 | China |
| The First People's Hospital of Changde City-Endocrinology | Changde | Hunan | 415003 | China |
| Changzhou No.2 People's Hospital | Changzhou | Jiangsu | 213003 | China |
| The First People's Hospital of Changzhou | Changzhou | Jiangsu | 213003 | China |
| The First People's Hospital of Changzhou | Changzhou | Jiangsu | 213004 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
| Suzhou Municipal Hospital-Endocrinology | Suzhou | Jiangsu | 215002 | China |
| The First Affiliated Hospital of Soochow University-Endocrinology | Suzhou | Jiangsu | 215006 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221002 | China |
| The Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212001 | China |
| The first hospital of Jilin University | Changchun | Jilin | 130021 | China |
| The First Bethune hospital of Jilin University-Endocrinology | Changchun | Jilin | 130061 | China |
| Jinan Central Hospital | Ji'nan | Shandong | 250013 | China |
| Jinan Central Hospital | Jin'an | Shandong | 250013 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine | Shanghai | Shanghai Municipality | 200336 | China |
| Tongren Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200336 | China |
| Central Hospital of Minhang District, Shanghai-Endocrinology | Shanghai | Shanghai Municipality | 201199 | China |
| Central Hospital of Minhang District-Endocrinology | Shanghai | Shanghai Municipality | 201199 | China |
| Shanghai Pudong New Area People's Hospital-Endocrinology | Shanghai | Shanghai Municipality | 201200 | China |
| General Hospital of Tianjin Medical University-Endocrinology | Tianjin | Tianjin Municipality | 300052 | China |
| General Hospital of Tianjin Medical University | Tianjin | Tianjin Municipality | 300052 | China |
| The Second Hospital of Tianjin Medical University | Tianjin | Tianjin Municipality | 300211 | China |
| Huashan Hospital Fudan University | Jingan/Shanghai | 200040 | China |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000717792 | cagrilintide |
| C000591245 | semaglutide |
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