DRUG
Cagrilintide
Participants will receive 2.4 mg cagrilintide subcutaneously.
A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight
Status
Completed
Phase
Phase 3
Enrollment
300
Locations
37
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Semaglutide
Participants will receive 2.4 mg semaglutide subcutaneously.
DRUG
Placebo Semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.
DRUG
Placebo Cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.
Timeline
From registration to results.
First posted
Aug 18, 2023
Study start
Aug 15, 2023
Primary completion
Jan 6, 2025
Study completion
Feb 22, 2025
Results posted
Not reported
Registry updated
Jan 9, 2026
Outcomes
What the study measures.
Primary outcomes
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 44)
Measured in percentage (%)
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%
Time frame · From baseline (week 0) to end of treatment (week 44)
Measured as count of participants
Secondary outcomes
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%
Time frame · From baseline (week 0) to end of treatment (week 44)
Measured as count of participants
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 44)
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 44)
Measured in centimeter (cm)
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%
Time frame · From baseline (week 0) to end of treatment (week 44)
Measured as count of participants
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%
Time frame · From baseline (week 0) to end of treatment (week 44)
Measured as count of participants
CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 44)
Measured in centimeter (cm)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Glycated Haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 44)
Measured in percentage points
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Fasting Plasma Glucose (FPG)
Time frame · From baseline (week 0) to end of treatment (week 44)
Measured as millimole per liter (mmol/L)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in fasting serum insulin
Time frame · From baseline (week 0) to end of treatment (week 44)
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Systolic Blood Pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 44)
Measured in millimeter of mercury (mmHg)
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
37 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital-Endocrinology
Fuzhou, Fujian, China
Huizhou Central People's Hospital-Endocrinology
Huizhou, Guangdong, China
Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
Hengshui, Hebei, China
The Second Hospital of Hebei Medical University-Endocrinology
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Huaihe Hospital of Henan University-Endocrinology
Kaifeng, Henan, China
Huaihe Hospital of Henan University
Kaifeng, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
Luoyang, Henan, China
The First Affiliated Hospital of Henan university of Science
Luoyang, Henan, China
The Second Affiliated Hospital of Zhengzhou University-Endocrinology
Zhengzhou, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The First People's Hospital of Changde City-Endocrinology
Changde, Hunan, 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
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Suzhou Municipal Hospital-Endocrinology
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University-Endocrinology
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The first hospital of Jilin University
Changchun, Jilin, China
The First Bethune hospital of Jilin University-Endocrinology
Changchun, Jilin, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Cagrilintide.
NCT IDStudyPhase / statusEnrollmentUpdated
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