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
2 other identifiers
interventional
300
1 country
37
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2023
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2023
CompletedStudy Start
First participant enrolled
August 15, 2023
CompletedFirst Posted
Study publicly available on registry
August 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2025
CompletedJanuary 9, 2026
January 1, 2026
1.4 years
August 10, 2023
January 4, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (26)
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%
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
From baseline (week 0) to end of treatment (week 44)
CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference
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%
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%
From baseline (week 0) to end of treatment (week 44)
- +21 more secondary outcomes
Study Arms (3)
CagriSema
EXPERIMENTALParticipants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.
Semaglutide
ACTIVE COMPARATORParticipants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.
Placebo
PLACEBO COMPARATORParticipants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.
Interventions
Participants will receive placebo matched to semaglutide subcutaneously.
Participants will receive placebo matched to cagrilintide subcutaneously.
Eligibility Criteria
You may qualify if:
- Male or female
- Age above or equal to 18 years at the time of signing informed consent
- Body Mass Index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m\^2) or
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (37)
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing Municipality, 100853, China
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Reporting Office (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2023
First Posted
August 18, 2023
Study Start
August 15, 2023
Primary Completion
January 6, 2025
Study Completion
February 22, 2025
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com