Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New obesity drug shows promise in japanese trial

NCT ID NCT06176365

Disease control Sponsor: Boehringer Ingelheim 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new medicine called survodutide for weight loss in 274 Japanese adults with obesity and related health problems like diabetes or high blood pressure. Participants received weekly injections of survodutide or a placebo for about 1.5 years, along with diet and exercise advice. The main goals were to see how much weight they lost and if at least 5% of body weight was reduced.

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

274 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2025

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 years and older

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: 1. Male or female, age ≥18 years at the time of signing informed consent 2. Body Mass Index (BMI) * ≥35 kg/m² at screening with the presence of at least one obesity-related comorbidities (treated or untreated) according to the Japan Society for the Study of Obesity (JASSO) guideline OR * BMI ≥27 kg/m² at screening with the presence of at least two obesity-related comorbidities (treated or untreated) according to the JASSO guideline For all trial patients, at least one co-morbidity should be the following (i)-(iii). i. Type 2 diabetes mellitus (T2DM) * Diagnosed with T2DM (defined as Glycosylated haemoglobin A1c (HbA1c) ≥6.5% \[≥48 mmol/mol\]) at least 180 days prior to screening * HbA1c ≥6.5% (48 mmol/mol) and \<10% (86 mmol/mol) as measured by the central laboratory at screening * Currently treated with either: diet and exercise alone or stable treatment (for at least 3 months prior to screening) with metformin, SGLT-2i, acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 antihyperglycaemia medications (metformin, SGLT-2i, acarbose, sulfonylurea, or glitazone) according to local label ii. Hypertension iii. Dyslipidaemia 3. History of at least one self-reported unsuccessful dietary effort to lose body weight 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 5. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use will be provided in the patient information. 6. In the investigator's opinion, patients are well-motivated, capable, and willing to: * Learn how to self-inject the Investigational medicinal product (IMP), as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP) OR * Inject the IMP or accept injection from a designated person * Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise and exercise plan), maintain a diary, and complete required questionnaires, and handle the IMP as described in the instructions for use (IFU) Exclusion criteria: Obesity: 1. Body weight change (self-reported) \>5% within 3 months before screening 2. Treatment with any medication for the indication obesity within 3 months before screening 3. Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, or prior surgery of the gastrointestinal (GI) tract that could interfere with body weight The following are allowed: (1) liposuction and/or abdominoplasty, if performed \>1 year before screening, (2) lap banding, if the band has been removed \>1 year before screening, (3) intragastric balloon, if the balloon has been removed \>1 year before screening, (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \>1 year before screening, (5) appendectomy, (6) simple hernia repair, or (7) cholecystectomy. 4. Have obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (i.e. melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome) Glycaemia: For trial patients without T2DM: 5. History of T1DM or T2DM or treatment with glucose lowering agent started within 3 months before screening For trial patients with T2DM: 6. History of T1DM 7. Treatment with any medication for the indication of T2DM other than stated in the inclusion criteria within 3 months before screening (i.e. insulin, amylin analogues, GLP-1R agonists, GLP-1R agonist/insulin/GIP combinations, and DPP-4i) 8. New initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial Further exclusion criteria apply.

Get updates

Get notified about this study

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

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

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

Obesity

Contacts and locations

Locations

  • Chiba University Hospital

    Chiba, Chiba, 260-8677, Japan

  • Clinical Research Hospital Tokyo

    Tokyo, Shinjuku-ku, 160-0004, Japan

  • Dojinkinenkai Meiwa Hospital

    Tokyo, Chiyoda-ku, 101-0041, Japan

  • Fukuwa Clinic

    Tokyo, Chuo-ku, 104-0031, Japan

  • Gifu University Hospital

    Gifu, Gifu, 501-1194, Japan

  • HS Clinic

    Tokyo, Shinjuku-ku, 169-0072, Japan

  • Hosokawa Surgery Clinic

    Aichi, Nagoya, 453-0812, Japan

  • Ijinkai Takeda General Hospital

    Kyoto, Kyoto, 601-1495, Japan

  • Ikebukuro Metropolitan Clinic

    Tokyo, Toshima-ku, 171-0021, Japan

  • Jiyugaoka Yamada Clinic

    Hokkaido, Obihiro, 080-0848, Japan

  • Kobe University Hospital

    Hyogo, Kobe, 650-0017, Japan

  • Medical Corporation KEISEIKAI Kajiyama Clinic

    Kyoto, Kyoto, 600-8898, Japan

  • Morinagaueno Clinic

    Kumamoto, Kumamoto, 860-0863, Japan

  • Motomachi Takatsuka Naika Clinic

    Kanagawa, Yokohama, 231-0023, Japan

  • Nagoya City University Hospital

    Aichi, Nagoya, 467-8602, Japan

  • New Medical Research System Clinic

    Tokyo, Hachioji, 192-0046, Japan

  • OCROM Clinic

    Osaka, Suita, 565-0853, Japan

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586, Japan

  • Saino Clinic

    Saitama, Tokorozawa, 359-1141, Japan

  • Shimamura Kinen Hospital

    Tokyo, Nerima-ku, 177-0051, Japan

  • Shinei Medical Healthcare Clinic

    Tokyo, Suginami-ku, 166-0003, Japan

  • Suidoubashi Medical Clinic

    Tokyo, Chiyoda-ku, 101-0065, Japan

  • ToCROM Clinic

    Tokyo, Shinjyuku-ku, 160-0008, Japan

  • Tokyo Asbo Clinic

    Tokyo, Chuo-ku, 104-0031, Japan

  • Tokyo Center Clinic

    Tokyo, Chuo-ku, 103-0028, Japan

  • Tokyo-Eki Center-building Clinic

    Tokyo, Chuo-ku, 103-0027, Japan

  • Yamasaki Family Clinic

    Hyogo, Amagasaki, 660-0861, Japan

  • Yoshimura Clinic

    Kumamoto, Kumamoto, 861-8039, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.