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

Last updated: March 5, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Prevention

Obesity

Hypertriglyceridemia

Treatment

Cagrilintide

Semaglutide

Placebo Semaglutide

Clinical Study ID

NCT05996848
NN9838-4827
U1111-1267-4364
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 oneweight-related comorbidity including, but not limited to, type 2 diabetesmellitus, hypertension, dyslipidaemia, obstructive sleep apnoea orcardiovascular 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 beforescreening

  • Treatment with either lifestyle intervention, or treatment with 1-3 marketed oralantidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides,sodium-glucose cotransporter 2 inhibitor (SGLT2i)), thiazolidinediones, orsulphonylureas (SUs) as a single agent or in combination) according to local label

  • Treatment with oral antidiabetic drugs should be stable (same drug(s), dose anddosing 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

Exclusion Criteria:

For participants without T2D at screening:

  • HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the centrallaboratory 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 orhistory of hypoglycaemia unawareness

  • Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30milli liter per min/1.73 meter square (mL/min/1.73 m^2), as measured by the centrallaboratory at screening

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby a fundus examination performed within 90 days before screening or in the periodbetween screening and randomisation. Pharmacological pupil-dilation is a requirementunless using a digital fundus photography camera specified for non-dilatedexamination

Study Design

Total Participants: 300
Treatment Group(s): 4
Primary Treatment: Cagrilintide
Phase: 3
Study Start date:
August 15, 2023
Estimated Completion Date:
February 22, 2025

Connect with a study center

  • Chinese People's Liberation Army General Hospital

    Beijing, Beijing 100853
    China

    Site Not Available

  • Chinese People's Liberation Army General Hospital-Endocrinology

    Beijing, Beijing 100853
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Beijing, Beijing 100853
    China

    Active - Recruiting

  • Chongqing University Three Gorges Hospital

    ChongQing, Chongqing 404000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    ChongQing, Chongqing 404000
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Fujian Medical University Union Hospital-Endocrinology

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • Huizhou Central People's Hospital

    Huizhou, Guangdong 516001
    China

    Site Not Available

  • Huizhou Central People's Hospital-Endocrinology

    Huizhou, Guangdong 516001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Huizhou, Guangdong 516001
    China

    Active - Recruiting

  • Harrison International Peace Hospital

    Hengshui, Hebei 053000
    China

    Site Not Available

  • Harrison International Peace Hospital-Endocrinology

    Hengshui, Hebei 053000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Hengshui, Hebei 053000
    China

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Shijiazhuang, Hebei 050000
    China

    Active - Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University-Endocrinology

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • Huaihe Hospital of Henan University

    Kaifeng, Henan 475000
    China

    Site Not Available

  • Huaihe Hospital of Henan University-Endocrinology

    Kaifeng, Henan 475000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Kaifeng, Henan 450000
    China

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Luoyang, Henan 471003
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology

    Luoyang, Henan 471003
    China

    Site Not Available

  • The First Affiliated Hospital of Henan university of Science

    Luoyang, Henan 471003
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhengzhou University-Endocrinology

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Changde, Hunan 415003
    China

    Active - Recruiting

  • The First People's Hospital of Changde City

    Changde, Hunan 415003
    China

    Site Not Available

  • The First People's Hospital of Changde City-Endocrinology

    Changde, Hunan 415003
    China

    Site Not Available

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu 213003
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Changzhou, Jiangsu 213003
    China

    Site Not Available

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu 213003
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu 215002
    China

    Site Not Available

  • Suzhou Municipal Hospital-Endocrinology

    Suzhou, Jiangsu 215002
    China

    Site Not Available

  • The First Affiliated Hospital Of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University-Endocrinology

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Xuzhou, Jiangsu 221002
    China

    Active - Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221002
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • The Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • The First Bethune hospital of Jilin University-Endocrinology

    Changchun, Jilin 130061
    China

    Site Not Available

  • The first hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Jinan Central Hospital

    Ji'nan, Shandong 250013
    China

    Site Not Available

  • Jinan Central Hospital

    Jin'an, Shandong 250013
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Jin'an, Shandong 250013
    China

    Site Not Available

  • Central Hospital of Minhang District

    Shanghai, Shanghai 201199
    China

    Site Not Available

  • Central Hospital of Minhang District-Endocrinology

    Shanghai, Shanghai 201199
    China

    Site Not Available

  • Huashan Hospital Fudan University

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Shanghai, Shanghai 200336
    China

    Site Not Available

  • Shanghai Pudong New Area People's Hospital

    Shanghai, Shanghai 201200
    China

    Site Not Available

  • Shanghai Pudong New Area People's Hospital-Endocrinology

    Shanghai, Shanghai 201200
    China

    Site Not Available

  • Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine

    Shanghai, Shanghai 200336
    China

    Site Not Available

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • General Hospital of Tianjin Medical University-Endocrinology

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin 300211
    China

    Site Not Available

  • Huashan Hospital Fudan University

    Jingan/Shanghai, 200040
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Jingan/Shanghai, 200040
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.