Current partner codePEPTIDESDE
NCT05813925·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

331

Locations

28

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Cagrilintide

Participants will receive 2.4 mg cagrilintide s.c. OW after a dose escalation period of 16 weeks for 52 weeks

DRUG

Semaglutide

Participants will receive 2.4 mg semaglutide s.c. OW after a dose escalation period of 16 weeks for 52 weeks

DRUG

Placebo Semaglutide

Participants will receive placebo matched to semaglutide

Timeline

From registration to results.

  1. First posted

    Apr 14, 2023

  2. Study start

    Apr 3, 2023

  3. Primary completion

    Jan 17, 2025

  4. Study completion

    Mar 7, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Jan 22, 2026

Outcomes

What the study measures.

Primary outcomes

Relative Change in Body Weight

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured in percentage (%)

Secondary outcomes

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured as count of participants

Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured in centimeter (cm)

Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured as percentage point

Change in VFA Measured by CT Scan in Subset of the Japanese Study Population

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured in centimeter square (cm\^2)

Number of Participants Who Achieve (Yes/No): VFA lesser than 100 cm^2 (Only for Participants with VFA greater than or equal to 100 cm^2 at Baseline)

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured as count of participants

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 25 Percent

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured as count of participants

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured as count of participants

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured as count of participants

Relative Change in Body Weight

Time frame · From baseline (week 0) to week 20

Measured in percentage (%)

Change in Body Weight

Time frame · From baseline (week 0) to end of treatment (week 68)

Measured in kilogram (kg)

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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 Exclusion Criteria: Obesity-related \- Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening Glycaemia-related for participant without T2D * 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 Diabetes-related for participant with T2D * 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 * Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness * 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

Study locations

28 registered sites.

Japan · Taiwan. Showing up to 24 locations stored in the fast local snapshot.

Seino Internal Medicine Clinic_Internal medicine

Koriyama-shi, Fukushima, Fukushima, Japan, Japan

Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

Yamato-shi, Kanagawa, Japan

Tsuruma Kaneshiro Diabetes Clinic

Yamato-shi, Kanagawa, Japan

Heiwadai Hospital_Internal Medicine

Miyazaki, Miyazaki, Japan

OCROM Clinic_Internal medicine

Suita-shi, Osaka, Japan

Yao Tokushukai General Hospital_Cardiovascular division

Yao-shi, Osaka, Japan

TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

Aichi, Japan

The University of Tokyo Hospital, Diabetes and Metabolic

Bunkyo-ku, Tokyo, Japan

Akaicho Clinic

Chiba-shi, Chiba, Japan

Suidoubashi Medical Clinic_Internal Medicine

Chiyoda-ku, Tokyo, Japan

The Institute of Medical Science, Asahi Life Foundation_Internal Medicine

Chuo-ku, Tokyo, Japan

The Institute of Medical Science, Asahi Life Foundation

Chuo-ku, Tokyo, Japan

Okabe Clinic

Chuo-ku, Tokyo, Japan

Kawada Clinic

Gunma, Japan

Naka Kinen Clinic_Internal medicine

Ibaraki, Japan

Naka Kinen Clinic

Ibaraki, Japan

Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine

Numakunai, Japan

Osaka NISHI-UMEDA Clinic_Internal Medicine

Osaka, Japan

Osaka NISHI-UMEDA Clinic

Osaka, Japan

Shinsapporo Seiryou Hospital, General Clinical Department

Sapporo-shi, Hokkaido, Japan

Shinden Higashi Clinic_Internal medicine

Sendai-shi, Miyagi, Japan

Shinden Higashi Clinic

Sendai-shi, Miyagi, Japan

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, Japan

Fukuwa Clinic_Internal Medicine

Tokyo, Japan

Related trials

More studies on Cagrilintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.