NCT05813925CompletedPhase 3
A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight
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 East Asian Participants With Overweight or Obesity
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
This study will look at how well the new medicine CagriSema helps people with excess body weight lose weight compared to another medicine, semaglutide. The participants will receive one injection once a week. The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1½ years.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 331 (actual)
- First submitted
- 3 Apr 2023
- Start date
- 3 Apr 2023
- Primary completion date
- 17 Jan 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity
- NCT number
- NCT05813925
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 331
- From 3 Apr 2023 to the primary completion date, 17 Jan 2025
- 28 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before 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
Other illness
- History of type 1 or type 2 diabetes
- Diabetes-related for participant with T2D
- Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness
Lab values
- HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
- 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 central laboratory at screening
Other
- Obesity-related
- Glycaemia-related for participant without T2D
Who the study is looking for
- Male or female
- Age greater than to or equal 18 years at the time of signing informed consent
- a) Body mass index (BMI) greater than or equal to 27.0 kilograms per square meter (kg/m\^2) with greater than or equal to 2 obesity-related complications or b) BMI greater than or equal to 35.0 kg/m\^2 with greater than or equal to 1 obesity-related complication. At least one complication should be hypertension, dyslipidaemia or T2D
- Diabetes-related for participant with T2D
- Diagnosed with T2D greater than or equal to 180 days before screening
- HbA1c 7.0-10.0 percent (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as measured by central laboratory at screening
- Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors \[AGI\], glinides, sodium-glucose cotransporter 2 inhibitor \[SGLT2i\]), thiazolidinediones, or sulphonylureas \[SU\] 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 90 days before screening
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology Coordinator of this site? Confirm its status | Aichi | Japan | Unknown status |
| The University of Tokyo Hospital, Diabetes and Metabolic Coordinator of this site? Confirm its status | Bunkyo-ku, Tokyo | Japan | Unknown status |
| Akaicho Clinic Coordinator of this site? Confirm its status | Chiba-shi, Chiba | Japan | Unknown status |
| Suidoubashi Medical Clinic_Internal Medicine Coordinator of this site? Confirm its status | Chiyoda-ku, Tokyo | Japan | Unknown status |
| Okabe Clinic Coordinator of this site? Confirm its status | Chuo-ku, Tokyo | Japan | Unknown status |
| The Institute of Medical Science, Asahi Life Foundation Coordinator of this site? Confirm its status | Chuo-ku, Tokyo | Japan | Unknown status |
| The Institute of Medical Science, Asahi Life Foundation_Internal Medicine Coordinator of this site? Confirm its status | Chuo-ku, Tokyo | Japan | Unknown status |
| Kawada Clinic Coordinator of this site? Confirm its status | Gunma | Japan | Unknown status |
| Naka Kinen Clinic_Internal medicine Coordinator of this site? Confirm its status | Ibaraki | Japan | Unknown status |
| Naka Kinen Clinic Coordinator of this site? Confirm its status | Ibaraki | Japan | Unknown status |
| Seino Internal Medicine Clinic_Internal medicine Coordinator of this site? Confirm its status | Koriyama-shi, Fukushima | Japan | Unknown status |
| Heiwadai Hospital_Internal Medicine Coordinator of this site? Confirm its status | Miyazaki | Japan | Unknown status |
| Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine Coordinator of this site? Confirm its status | Numakunai | Japan | Unknown status |
| Osaka NISHI-UMEDA Clinic_Internal Medicine Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Osaka NISHI-UMEDA Clinic Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Shinsapporo Seiryou Hospital, General Clinical Department Coordinator of this site? Confirm its status | Sapporo-shi, Hokkaido | Japan | Unknown status |
| Shinden Higashi Clinic Coordinator of this site? Confirm its status | Sendai-shi, Miyagi | Japan | Unknown status |
| Shinden Higashi Clinic_Internal medicine Coordinator of this site? Confirm its status | Sendai-shi, Miyagi | Japan | Unknown status |
| OCROM Clinic_Internal medicine Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| Fukuwa Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Minamino Cardiovascular Hospital_Cardiovascular medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Fukuwa Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| ToCROM Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Tokyo-Eki Center-building Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Tsuruma Kaneshiro Diabetes Clinic Coordinator of this site? Confirm its status | Yamato-shi | Japan | Unknown status |
| Tsuruma Kaneshiro Diabetes Clinic_Internal medicine Coordinator of this site? Confirm its status | Yamato-shi | Japan | Unknown status |
| Yao Tokushukai General Hospital_Cardiovascular division Coordinator of this site? Confirm its status | Yao-shi | Japan | Unknown status |
| National Taiwan University Hospital_main Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
Related publications
- Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial.Lancet Diabetes Endocrinol · 2026 · PMID 42009015
This page is information, not medical advice. Discuss any trial with your doctor.