A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease

NCT06176365 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 1404-0053
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 28

Brief Summary

This study is open to adults who are at least 18 years old and have

• a body mass index (BMI) of 35 kg/m² or more and at least one health problem related to their weight, or
• a BMI of 27 kg/m² or more and at least two health problems related to their weight. People who have either type 2 diabetes, high blood pressure, or increased blood lipids can take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with obesity disease to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. The results are compared between the groups to see whether the treatment works.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Percentage change in body weight from baseline to Week 76

  at baseline, at week 76

• Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76

  at baseline, at week 76

Secondary Outcomes (34)

• Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76

  at baseline, at week 76

• Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76

  at baseline, at week 76

• Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76

  at baseline, at week 76

• Absolute change from baseline to Week 76 in body weight (kg)

  at baseline, at week 76

• Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m²)

  at baseline, at week 76

Study Arms (3)

Survodutide - 3.6 mg

EXPERIMENTAL

Drug: Survodutide

Survodutide - 6.0 mg

EXPERIMENTAL

Drug: Survodutide

Placebo group

PLACEBO COMPARATOR

Drug: Placebo matching survodutide

Interventions

Survodutide DRUG

once weekly subcutaneous injection

Also known as: BI 456906

Survodutide - 3.6 mg; Survodutide - 6.0 mg

Placebo matching survodutide DRUG

once weekly subcutaneous injection

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥18 years at the time of signing informed consent
• 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
• History of at least one self-reported unsuccessful dietary effort to lose body weight
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
• 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.
• 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)

You may not qualify if:

• Obesity:
• Body weight change (self-reported) \>5% within 3 months before screening
• Treatment with any medication for the indication obesity within 3 months before screening
• 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.
• 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:
• History of T1DM or T2DM or treatment with glucose lowering agent started within 3 months before screening
• For trial patients with T2DM:
• History of T1DM
• New initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (28)

Hosokawa Surgery Clinic

Aichi, Nagoya, 453-0812, Japan

Location

Nagoya City University Hospital

Aichi, Nagoya, 467-8602, Japan

Location

Chiba University Hospital

Chiba, Chiba, 260-8677, Japan

Location

Gifu University Hospital

Gifu, Gifu, 501-1194, Japan

Location

Jiyugaoka Yamada Clinic

Hokkaido, Obihiro, 080-0848, Japan

Location

Yamasaki Family Clinic

Hyogo, Amagasaki, 660-0861, Japan

Location

Kobe University Hospital

Hyogo, Kobe, 650-0017, Japan

Location

Motomachi Takatsuka Naika Clinic

Kanagawa, Yokohama, 231-0023, Japan

Location

Morinagaueno Clinic

Kumamoto, Kumamoto, 860-0863, Japan

Location

Yoshimura Clinic

Kumamoto, Kumamoto, 861-8039, Japan

Location

Medical Corporation KEISEIKAI Kajiyama Clinic

Kyoto, Kyoto, 600-8898, Japan

Location

Ijinkai Takeda General Hospital

Kyoto, Kyoto, 601-1495, Japan

Location

Osaka Metropolitan University Hospital

Osaka, Osaka, 545-8586, Japan

Location

OCROM Clinic

Osaka, Suita, 565-0853, Japan

Location

Saino Clinic

Saitama, Tokorozawa, 359-1141, Japan

Location

Dojinkinenkai Meiwa Hospital

Tokyo, Chiyoda-ku, 101-0041, Japan

Location

Suidoubashi Medical Clinic

Tokyo, Chiyoda-ku, 101-0065, Japan

Location

Tokyo-Eki Center-building Clinic

Tokyo, Chuo-ku, 103-0027, Japan

Location

Tokyo Center Clinic

Tokyo, Chuo-ku, 103-0028, Japan

Location

Fukuwa Clinic

Tokyo, Chuo-ku, 104-0031, Japan

Location

Tokyo Asbo Clinic

Tokyo, Chuo-ku, 104-0031, Japan

Location

New Medical Research System Clinic

Tokyo, Hachioji, 192-0046, Japan

Location

Shimamura Kinen Hospital

Tokyo, Nerima-ku, 177-0051, Japan

Location

Clinical Research Hospital Tokyo

Tokyo, Shinjuku-ku, 160-0004, Japan

Location

HS Clinic

Tokyo, Shinjuku-ku, 169-0072, Japan

Location

ToCROM Clinic

Tokyo, Shinjyuku-ku, 160-0008, Japan

Location

Shinei Medical Healthcare Clinic

Tokyo, Suginami-ku, 166-0003, Japan

Location

Ikebukuro Metropolitan Clinic

Tokyo, Toshima-ku, 171-0021, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Obesity

Interventions

BI 456906

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 19, 2023
• Study Start: January 16, 2024
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

JP (28)