Cure My Disease

Don't miss your cure!

 Log in / Sign up

New obesity drug shows promise in major japanese trial

NCT ID NCT06987695

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called maridebart cafraglutide to help adults in Japan with obesity lose weight. About 279 participants will receive either the drug or a placebo for 72 weeks. The main goals are to see how much weight they lose and if at least 5% of body weight is lost. This is a phase 3 trial, meaning it is in the final stage before possible approval.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

279 people

The number who actually took part.

Started

Jun 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Obesity disease are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Body Weight obesity disorder Overweight type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity disease

Contacts and locations

Locations

  • Adachi Kyosai Hospital

    Adachi-ku, Tokyo, 120-0022, Japan

  • Aira Diabetes Thyroid Internal Medicine Clinic

    Aira-shi, Kagoshima-ken, 899-5421, Japan

  • Deguchi Clinic

    Kobe, Hyōgo, 652-0803, Japan

  • Fukuoka Shinmizumaki Hospital

    Onga-gun, Fukuoka, 807-0051, Japan

  • Hosokawa Surgical Clinic

    Nagoya, Aichi-ken, 453-0812, Japan

  • Ikebukuro Metropolitan Clinic

    Toshima-ku, Tokyo, 171-0021, Japan

  • Joh Medical Clinic

    Osaka, Osaka, 530-0002, Japan

  • Kobe University Hospital

    Kobe, Hyōgo, 650-0017, Japan

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507, Japan

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582, Japan

  • MIH Clinic Yoyogi

    Shibuya-ku, Tokyo, 151-0051, Japan

  • Manda Memorial Hospital

    Sapporo, Hokkaido, 060-0062, Japan

  • Matsuba Clinic

    Kawasaki-shi, Kanagawa, 212-0024, Japan

  • Matsunami Health Promotion Clinic

    Hashima-gun, Gifu, 501-6061, Japan

  • Medical Corporation Boocs Boocs Clinic Fukuoka

    Fukuoka, Fukuoka, 812-0025, Japan

  • Medical Corporation Chiseikai Tokyo Center Clinic

    Chuo-ku, Tokyo, 103-0027, Japan

  • Medical Corporation Keiseikai Kajiyama Clinic

    Kyoto, Kyoto, 600-8898, Japan

  • Medical Corporation Kenshinkai Minamino Cardiovascular Hospital

    Hachioji-shi, Tokyo, 192-0918, Japan

  • Meitetsu Hospital

    Nagoya, Aichi-ken, 451-8511, Japan

  • Midori Clinic

    Nagasaki, Nagasaki, 852-8034, Japan

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo, 103-0025, Japan

  • Nishiyamado Keiwa Hospital

    Naka, Ibaraki, 311-0133, Japan

  • Shimamura Memorial Hospital

    Nerima-ku, Tokyo, 177-0051, Japan

  • Shinjuku Southern Clinic

    Shinjuku-ku, Tokyo, 160-0023, Japan

  • Social Medical Corporation Kojunkai Daido Clinic

    Nagoya, Aichi-ken, 457-8511, Japan

  • Tashiro Endocrinology Clinic

    Fukuoka, Fukuoka, 814-0153, Japan

  • Tokyo Saiseikai Central Hospital

    Minato-ku, Tokyo, 108-0073, Japan

  • Urasoe General Hospital

    Urasoe-shi, Okinawa, 901-2102, Japan

  • Wellness Tenjin Clinic

    Fukuoka, Fukuoka, 810-0001, Japan

  • Yamasaki Family Clinic

    Amagasaki-shi, Hyōgo, 660-0861, Japan