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

Status: Completed
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing
The First Bethune hospital of Jilin University-Endocrinology
Changchun
The first hospital of Jilin University
Changchun
The First People's Hospital of Changde City-Endocrinology
Changde
Changzhou No.2 People's Hospital
Changzhou
The First People's Hospital of Changzhou
Changzhou
Chongqing University Three Gorges Hospital
Chongqing
Fujian Medical University Union Hospital-Endocrinology
Fuzhou
Harrison International Peace Hospital-Endocrinology
Hengshui
Huizhou Central People's Hospital-Endocrinology
Huizhou
Jinan Central Hospital
Ji'nan
Jinan Central Hospital
Jin'an
Huashan Hospital Fudan University
Jingan/shanghai
Huaihe Hospital of Henan University
Kaifeng
Huaihe Hospital of Henan University-Endocrinology
Kaifeng
The First Affiliated Hospital of Henan university of Science
Luoyang
The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
Luoyang
The Second Affiliated Hospital of Nanjing Medical University
Nanjing
Central Hospital of Minhang District-Endocrinology
Shanghai
Huashan Hospital Fudan University
Shanghai
Shanghai Pudong New Area People's Hospital-Endocrinology
Shanghai
Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine
Shanghai
The Second Hospital of Hebei Medical University
Shijiazhuang
The Second Hospital of Hebei Medical University-Endocrinology
Shijiazhuang
Suzhou Municipal Hospital-Endocrinology
Suzhou
The First Affiliated Hospital of Soochow University-Endocrinology
Suzhou
General Hospital of Tianjin Medical University
Tianjin
General Hospital of Tianjin Medical University-Endocrinology
Tianjin
The Second Hospital of Tianjin Medical University
Tianjin
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou
The Second Affiliated Hospital of Zhengzhou University-Endocrinology
Zhengzhou
The Affiliated Hospital of Jiangsu University
Zhenjiang
Time Frame
Start Date: 2023-08-15
Completion Date: 2025-02-22
Participants
Target number of participants: 300
Treatments
Experimental: CagriSema
Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.
Active_comparator: Semaglutide
Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.
Placebo_comparator: Placebo
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov

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