A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight

Obesity or Overweight Clinical Trial

— REDEFINE 6  

Official title:

Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-Weekly in Chinese Participants With Overweight or Obesity

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
• 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
• 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

Related Conditions & MeSH terms

• Obesity
• Obesity or Overweight
• Overweight

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)