Current partner codePEPTIDESDE
NCT06987695·Phase 3·INTERVENTIONAL

Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease

Status

Active, not recruiting

Phase

Phase 3

Enrollment

279

Locations

30

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight and proportion of participants with ≥ 5% reduction in body weight.

Interventions

Treatment arms and agents.

DRUG

Maridebart cafraglutide

Maridebart cafraglutide will be administered SC.

DRUG

Placebo

Placebo will be administered SC.

Timeline

From registration to results.

  1. First posted

    May 23, 2025

  2. Study start

    Jun 13, 2025

  3. Primary completion

    Apr 27, 2027

  4. Study completion

    Jul 21, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Dec 17, 2025

Outcomes

What the study measures.

Primary outcomes

Percent Change From Baseline in Body Weight at Week 72

Time frame · Baseline and Week 72

Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 72

Time frame · Baseline and Week 72

Secondary outcomes

Change From Baseline in Waist Circumference at Week 72

Time frame · Baseline and Week 72

Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 72

Time frame · Baseline and Week 72

Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 72

Time frame · Baseline and Week 72

Change From Baseline in Body Weight at Week 72

Time frame · Baseline and Week 72

Percent Change From Baseline in Body Weight in Participants Without Type 2 Diabetes Mellitus (T2DM) at Week 72

Time frame · Baseline and Week 72

Percent Change From Baseline in Body Weight in Participants With T2DM at Week 72

Time frame · Baseline and Week 72

Change From Baseline in Body Mass Index (BMI) at Week 72

Time frame · Baseline and Week 72

Participants Achieving ≥ 20% Reduction in Body Weight from Baseline at Week 72

Time frame · Baseline and Week 72

Change From Baseline in Visceral Fat Area (VFA) at Week 72

Time frame · Baseline and Week 72

Participants Achieving VFA < 100 cm^2 in VFA at Week 72

Time frame · Week 72

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
99 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Age ≥ 18 years. * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. * Body mass index (BMI) ≥ 35 kg/m\^2 at screening with a current diagnosis of at least 1 of the weigh-related comorbidities specified in the Japan Society for the Study of Obesity (JASSO) guideline OR BMI ≥ 27 kg/m\^2 to \< 35 kg/m\^2 at screening, with a current diagnosis of at least 2 of the weight-related comorbidities specified in the JASSO guideline. * For both BMI categories, at least 1 of the weight-related comorbidities must be hypertension, dyslipidemia, or T2DM according to the definitions below: 1. hypertension: treated, or with SBP ≥ 140 mmHg, or DBP ≥ 90 mmHg at screening. 2. dyslipidemia: treated, or with LDL \> 140 mg/dL (3.6 mmol/L), or triglycerides ≥ 150 mg/dL (1.7 mmol/L), or non-HDL cholesterol \> 170 mg/dL (4.4 mmol/L) or HDL \< 40 mg/dL (1.0 mmol/L) at screening. 3. T2DM: diagnosed ≥ 180 days before screening, and treated with diet and exercise alone and/or a stable treatment for at least 90 days before screening with up to 3 oral glucose-lowering medications (as per local labeling) (except for glucagon-like peptide-1 receptor agonists \[GLP-1RA\] and dipeptidyl peptidase-4 \[DPP-4\] inhibitors), and have a HbA1c ≥ 7% and ≤ 10% (53-86 mmol/mol) at screening. * In the opinion of the investigator, well-motivated and willing to: 1. Follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice, maintain a study log(s)/diary(ies), and complete required study visits and questionnaires. 2. Perform self-monitoring blood glucose (SMBG) per protocol (only for participants with T2DM). Exclusion Criteria: * Obesity induced by other endocrinological disorders or monogenetic or syndromic forms of obesity. * Self-reported change in body weight \> 5 kg within 90 days before screening. * Previous or planned (during the study) surgical, endoscopic, or device-based treatment for obesity. * For participants without diabetes at screening, type 1 or 2 diabetes mellitus or any other types of diabetes mellitus (except history of gestational diabetes). * For participants with T2DM at screening, any other type(s) of diabetes mellitus except T2DM. * History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening. * Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2). * History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening. * Lifetime history of suicide attempt.

Study locations

30 registered sites.

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

Meitetsu Hospital

Nagoya, Aichi-ken, Japan

Hosokawa Surgical Clinic

Nagoya, Aichi-ken, Japan

Social Medical Corporation Kojunkai Daido Clinic

Nagoya, Aichi-ken, Japan

Wellness Tenjin Clinic

Fukuoka, Fukuoka, Japan

Medical Corporation Boocs Boocs Clinic Fukuoka

Fukuoka, Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Tashiro Endocrinology Clinic

Fukuoka, Fukuoka, Japan

Fukuoka Shinmizumaki Hospital

Onga-gun, Fukuoka, Japan

Matsunami Health Promotion Clinic

Hashima-gun, Gifu, Japan

Manda Memorial Hospital

Sapporo, Hokkaido, Japan

Yamasaki Family Clinic

Amagasaki-shi, Hyōgo, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Deguchi Clinic

Kobe, Hyōgo, Japan

Nishiyamado Keiwa Hospital

Naka, Ibaraki, Japan

Aira Diabetes Thyroid Internal Medicine Clinic

Aira-shi, Kagoshima-ken, Japan

Matsuba Clinic

Kawasaki-shi, Kanagawa, Japan

Medical Corporation Keiseikai Kajiyama Clinic

Kyoto, Kyoto, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

Midori Clinic

Nagasaki, Nagasaki, Japan

Urasoe General Hospital

Urasoe-shi, Okinawa, Japan

Joh Medical Clinic

Osaka, Osaka, Japan

Adachi Kyosai Hospital

Adachi-ku, Tokyo, Japan

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, Japan

Medical Corporation Chiseikai Tokyo Center Clinic

Chuo-ku, Tokyo, Japan

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Maridebart cafraglutide.

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.