A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight (REDEFINE 6)

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

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 Overview

• Status: Recruiting
• Conditions: Obesity or Overweight
• Intervention / Treatment: Drug: Cagrilintide; Drug: Semaglutide; Drug: Placebo Semaglutide; Drug: Placebo Cagrilintide

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• China
  • Jingan/Shanghai, China, 200040
    • Not yet recruiting
    • Huashan Hospital Fudan University
  • Jingan/Shanghai, China, 200040
    • Recruiting
    • Huashan Hospital Fudan University
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese People's Liberation Army General Hospital
  • Chongqing
    • ChongQing, Chongqing, China, 404000
      • Recruiting
      • Chongqing University Three Gorges Hospital
    • ChongQing, Chongqing, China, 404000
      • Not yet recruiting
      • Chongqing University Three Gorges Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
  • Guangdong
    • Huizhou, Guangdong, China, 516001
      • Recruiting
      • Huizhou Central People's Hospital
  • Hebei
    • Hengshui, Hebei, China, 053000
      • Recruiting
      • Harrison International Peace Hospital
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The Second Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China, 050000
      • Not yet recruiting
      • The Second Hospital of Hebei Medical University
  • Henan
    • Kaifeng, Henan, China, 450000
      • Recruiting
      • Huaihe Hospital of Henan University
    • Kaifeng, Henan, China, 475000
      • Not yet recruiting
      • Huaihe Hospital of Henan University
    • Luoyang, Henan, China, 471003
      • Recruiting
      • The First Affiliated Hospital of Henan university of Science
    • Luoyang, Henan, China, 471003
      • Not yet recruiting
      • The First Affiliated Hospital of Henan university of Science
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • The Second Affiliated Hospital Of Zhengzhou University
  • Hunan
    • Changde, Hunan, China, 415003
      • Recruiting
      • The First People's Hospital of Changde City
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • Recruiting
      • Changzhou No.2 People's Hospital
    • Changzhou, Jiangsu, China, 213003
      • Recruiting
      • The First People's Hospital of Changzhou
    • Changzhou, Jiangsu, China, 213003
      • Not yet recruiting
      • The First People's Hospital of Changzhou
    • Changzhou, Jiangsu, China, 213003
      • Not yet recruiting
      • Changzhou No.2 People's Hospital
    • Nanjing, Jiangsu, China, 210011
      • Not yet recruiting
      • The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • The Second Affiliated Hospital of Nanjing Medical University
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • The First Affiliated Hospital of Soochow University
    • Suzhou, Jiangsu, China, 215002
      • Recruiting
      • Suzhou Municipal Hospital
    • Xuzhou, Jiangsu, China, 221002
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University
    • Xuzhou, Jiangsu, China, 221002
      • Not yet recruiting
      • The Affiliated Hospital of Xuzhou Medical University
    • Zhenjiang, Jiangsu, China, 212001
      • Not yet recruiting
      • The Affiliated Hospital of Jiangsu University
    • Zhenjiang, Jiangsu, China, 212001
      • Recruiting
      • The Affiliated Hospital of Jiangsu University
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130021
      • Not yet recruiting
      • The First Hospital of Jilin University
  • Shandong
    • Ji'nan, Shandong, China, 250013
      • Recruiting
      • Jinan Central Hospital
    • Jin'an, Shandong, China, 250013
      • Not yet recruiting
      • Jinan Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200336
      • Recruiting
      • Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine
    • Shanghai, Shanghai, China, 201200
      • Recruiting
      • Shanghai Pudong New Area People's Hospital
    • Shanghai, Shanghai, China, 201199
      • Recruiting
      • Central Hospital of Minhang District
    • Shanghai, Shanghai, China, 200336
      • Not yet recruiting
      • Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine
    • Shanghai, Shanghai, China, 201199
      • Not yet recruiting
      • Central Hospital of Minhang District
  • Tianjin
    • Tianjin, Tianjin, China, 300211
      • Recruiting
      • The Second Hospital of Tianjin Medical University
    • Tianjin, Tianjin, China, 300052
      • Recruiting
      • General Hospital of Tianjin Medical University
    • Tianjin, Tianjin, China, 300211
      • Not yet recruiting
      • The Second Hospital of Tianjin Medical University
    • Tianjin, Tianjin, China, 300052
      • Not yet recruiting
      • General Hospital of Tianjin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, α-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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CagriSema; Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.	Drug: Cagrilintide; Participants will receive 2.4 mg cagrilintide subcutaneously.; Drug: Semaglutide; Participants will receive 2.4 mg semaglutide subcutaneously.
Active Comparator: Semaglutide; Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.	Drug: Semaglutide; Participants will receive 2.4 mg semaglutide subcutaneously.; Drug: Placebo Semaglutide; Participants will receive placebo matched to semaglutide subcutaneously.
Placebo Comparator: Placebo; Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.	Drug: Placebo Semaglutide; Participants will receive placebo matched to semaglutide subcutaneously.; Drug: Placebo Cagrilintide; Participants will receive placebo matched to cagrilintide subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Reporting Office (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Estimated): February 18, 2025
• Study Completion (Estimated): April 8, 2025

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; Semaglutide
• Other Study ID Numbers: NN9838-4827; U1111-1267-4364 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No