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NCT06176365: SYNCHRONIZE™JP

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

Completed Phase 3 Last updated 12 December 2025
What this trial tests

Phase 3 trial testing Survodutide in Obesity in 274 participants. Completed in 3 December 2025.

Timeline
16 January 2024
Primary endpoint
3 December 2025
3 December 2025

Quick facts

Lead sponsorBoehringer Ingelheim
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment274
Start date16 January 2024
Primary completion3 December 2025
Estimated completion3 December 2025
Sites28 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2024.
    Tamargo J, Agewall S, Ambrosio G, Borghi C, et al · · 2025 · cited 6× · PMID 40058879 · DOI 10.1093/ehjcvp/pvaf012
  2. An Overview of Existing and Emerging Weight-Loss Drugs to Target Obesity-Related Complications: Insights from Clinical Trials.
    Kim MK, Kim HS. · · 2025 · cited 4× · PMID 39696983 · DOI 10.4062/biomolther.2024.228
  3. Review: Special Issue: <i>Real-world evidence on the use of GLP1 receptor agonists</i>: Emerging concepts in obesity management: focus on glucagon receptor agonist combinations.
    Anderson SL. · · 2025 · cited 2× · PMID 40734920 · DOI 10.7573/dic.2025-4-8
  4. Current Trends and Perspectives on Obesity and Metabolic Dysfunction-Associated Steatohepatitis in East Asia.
    Lim S, Zhou H, Ogawa W. · · 2026 · cited 1× · PMID 41771545 · DOI 10.7570/jomes25083
  5. Survodutide for the Treatment of Obesity Disease in Japanese Participants: Rationale, Design and Baseline Characteristics of the Phase 3 SYNCHRONIZE-JP Trial.
    Yokote K, Yamauchi T, Fukushima Y, Takatsuka Y, et al · · 2026 · PMID 42219222 · DOI 10.1111/dom.70862

Verify or expand the search:

Other trials of Survodutide

Trials testing the same drug.

Other recruiting trials for Obesity

Currently open trials in the same condition.

Other Boehringer Ingelheim trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06176365.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing