A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight
NCT ID: NCT05996848
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2023-08-15
2025-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CagriSema
Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.
Cagrilintide
Participants will receive 2.4 mg cagrilintide subcutaneously.
Semaglutide
Participants will receive 2.4 mg semaglutide subcutaneously.
Semaglutide
Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.
Semaglutide
Participants will receive 2.4 mg semaglutide subcutaneously.
Placebo Semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.
Placebo
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.
Placebo Semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.
Placebo Cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Office (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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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
Jinan Central Hospital
Ji'nan, Shandong, China
Jinan Central Hospital
Jin'an, Shandong, China
Jinan Central Hospital
Jinan, Shandong, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine
Shanghai, Shanghai Municipality, China
Tongren Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Central Hospital of Minhang District, Shanghai-Endocrinology
Shanghai, Shanghai Municipality, China
Central Hospital of Minhang District-Endocrinology
Shanghai, Shanghai Municipality, China
Shanghai Pudong New Area People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, China
General Hospital of Tianjin Medical University-Endocrinology
Tianjin, Tianjin Municipality, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Huashan Hospital Fudan University
Jingan/Shanghai, , China
Countries
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Other Identifiers
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U1111-1267-4364
Identifier Type: OTHER
Identifier Source: secondary_id
NN9838-4827
Identifier Type: -
Identifier Source: org_study_id
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