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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05996848
Other study ID # NN9838-4827
Secondary ID U1111-1267-4364
Status Recruiting
Phase Phase 3
First received
Last updated
Start date August 15, 2023
Est. completion date April 8, 2025

Study information

Verified date April 2024
Source Novo Nordisk A/S
Contact Novo Nordisk
Phone (+1) 866-867-7178
Email clinicaltrials@novonordisk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date April 8, 2025
Est. primary completion date February 18, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female - Age above or equal to 18 years at the time of signing informed consent 1. Body Mass Index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m^2) or 2. 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, type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease For participants with Type 2 diabetes (T2D) at screening the following criteria also apply: - Diagnosed with type 2 diabetes mellitus greater than equal to 180 days before screening - Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OADs) (metformin, a-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i)), thiazolidinediones, or sulphonylureas (SUs) as a single agent or in combination) according to local label - Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 60 days before screening - Glycated Haemoglobin (HbA1c) 7 percent-10 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by the central laboratory at screening Exclusion Criteria: For participants without T2D at screening: - HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening - History of type 1 or type 2 diabetes mellitus For participants with T2D at screening: - Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness - Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m^2), as measured by the central laboratory at screening - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cagrilintide
Participants will receive 2.4 mg cagrilintide subcutaneously.
Semaglutide
Participants will receive 2.4 mg semaglutide subcutaneously.
Placebo Semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.
Placebo Cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.

Locations

Country Name City State
China Chinese People's Liberation Army General Hospital Beijing Beijing
China The first hospital of Jilin University Changchun Jilin
China The first hospital of Jilin University Changchun Jilin
China The First People's Hospital of Changde City Changde Hunan
China Changzhou No.2 People's Hospital Changzhou Jiangsu
China Changzhou No.2 People's Hospital Changzhou Jiangsu
China The First People's Hospital of Changzhou Changzhou Jiangsu
China The First People's Hospital of Changzhou Changzhou Jiangsu
China Chongqing University Three Gorges Hospital ChongQing Chongqing
China Chongqing University Three Gorges Hospital ChongQing Chongqing
China Fujian Medical University Union Hospital Fuzhou Fujian
China Harrison International Peace Hospital Hengshui Hebei
China Huizhou Central People's Hospital Huizhou Guangdong
China Jinan Central Hospital Ji'nan Shandong
China Jinan Central Hospital Jin'an Shandong
China Huashan Hospital Fudan University Jingan/Shanghai
China Huashan Hospital Fudan University Jingan/Shanghai
China Huaihe Hospital of Henan University Kaifeng Henan
China Huaihe Hospital of Henan University Kaifeng Henan
China The First Affiliated Hospital of Henan university of Science Luoyang Henan
China The First Affiliated Hospital of Henan university of Science Luoyang Henan
China The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
China The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
China Central Hospital of Minhang District Shanghai Shanghai
China Central Hospital of Minhang District Shanghai Shanghai
China Shanghai Pudong New Area People's Hospital Shanghai Shanghai
China Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine Shanghai Shanghai
China Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine Shanghai Shanghai
China The Second Hospital of Hebei Medical University Shijiazhuang Hebei
China The Second Hospital of Hebei Medical University Shijiazhuang Hebei
China Suzhou Municipal Hospital Suzhou Jiangsu
China The First Affiliated Hospital Of Soochow University Suzhou Jiangsu
China General Hospital of Tianjin Medical University Tianjin Tianjin
China General Hospital of Tianjin Medical University Tianjin Tianjin
China The Second Hospital of Tianjin Medical University Tianjin Tianjin
China The Second Hospital of Tianjin Medical University Tianjin Tianjin
China The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
China The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
China The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan
China The Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu
China The Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

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 44)
Primary 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)
Secondary 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)
Secondary CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight Measured in percentage (%) From baseline (week 0) to end of treatment (week 44)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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