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NCT06176365: SYNCHRONIZE™JP
A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease
Phase 3 trial testing Survodutide in Obesity in 274 participants. Completed in 3 December 2025.
3 December 2025
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 274 |
| Start date | 16 January 2024 |
| Primary completion | 3 December 2025 |
| Estimated completion | 3 December 2025 |
| Sites | 28 locations across Japan |
Drugs / interventions tested
- Survodutide — full drug profile →
- Placebo matching survodutide — full drug profile →
Conditions studied
- Obesity — all drugs for Obesity →
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):
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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 -
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 -
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 -
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 -
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:
- PubMed search for NCT06176365
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Survodutide
Trials testing the same drug.
- NCT06745284 — A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity · Phase 1 · active not recruiting
- NCT06632457 — LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have C · Phase 3 · recruiting
- NCT06564441 — A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood · Phase 1 · completed
- NCT06632444 — LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or A · Phase 3 · recruiting
- NCT06309992 — A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Live · Phase 3 · completed
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Currently open trials in the same condition.
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Other Boehringer Ingelheim trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06176365 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
- Last refreshed: 12 December 2025
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