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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

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
Coordinator of this site? Confirm its status
AichiJapanUnknown status
The University of Tokyo Hospital, Diabetes and Metabolic
Coordinator of this site? Confirm its status
Bunkyo-ku, TokyoJapanUnknown status
Akaicho Clinic
Coordinator of this site? Confirm its status
Chiba-shi, ChibaJapanUnknown status
Suidoubashi Medical Clinic_Internal Medicine
Coordinator of this site? Confirm its status
Chiyoda-ku, TokyoJapanUnknown status
Okabe Clinic
Coordinator of this site? Confirm its status
Chuo-ku, TokyoJapanUnknown status
The Institute of Medical Science, Asahi Life Foundation
Coordinator of this site? Confirm its status
Chuo-ku, TokyoJapanUnknown status
The Institute of Medical Science, Asahi Life Foundation_Internal Medicine
Coordinator of this site? Confirm its status
Chuo-ku, TokyoJapanUnknown status
Kawada Clinic
Coordinator of this site? Confirm its status
GunmaJapanUnknown status
Naka Kinen Clinic_Internal medicine
Coordinator of this site? Confirm its status
IbarakiJapanUnknown status
Naka Kinen Clinic
Coordinator of this site? Confirm its status
IbarakiJapanUnknown status
Seino Internal Medicine Clinic_Internal medicine
Coordinator of this site? Confirm its status
Koriyama-shi, FukushimaJapanUnknown status
Heiwadai Hospital_Internal Medicine
Coordinator of this site? Confirm its status
MiyazakiJapanUnknown status
Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine
Coordinator of this site? Confirm its status
NumakunaiJapanUnknown status
Osaka NISHI-UMEDA Clinic_Internal Medicine
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Osaka NISHI-UMEDA Clinic
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Shinsapporo Seiryou Hospital, General Clinical Department
Coordinator of this site? Confirm its status
Sapporo-shi, HokkaidoJapanUnknown status
Shinden Higashi Clinic
Coordinator of this site? Confirm its status
Sendai-shi, MiyagiJapanUnknown status
Shinden Higashi Clinic_Internal medicine
Coordinator of this site? Confirm its status
Sendai-shi, MiyagiJapanUnknown status
OCROM Clinic_Internal medicine
Coordinator of this site? Confirm its status
Suita-shiJapanUnknown status
Fukuwa Clinic_Internal Medicine
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
Minamino Cardiovascular Hospital_Cardiovascular medicine
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
Fukuwa Clinic
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
ToCROM Clinic_Internal Medicine
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
Tokyo-Eki Center-building Clinic_Internal Medicine
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
Tsuruma Kaneshiro Diabetes Clinic
Coordinator of this site? Confirm its status
Yamato-shiJapanUnknown status
Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
Coordinator of this site? Confirm its status
Yamato-shiJapanUnknown status
Yao Tokushukai General Hospital_Cardiovascular division
Coordinator of this site? Confirm its status
Yao-shiJapanUnknown status
National Taiwan University Hospital_main
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.