LivingGLP1
Study S000367

A Phase 3, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity Without Type 2 Diabetes

Registration

Registration
NCT06066515
Acronym
SYNCHRONIZE™-1
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
QUADRUPLE
Status
COMPLETED
Enrollment
726
Start
2023-11-25
Primary completion
2025-12-02
Lead sponsor
Boehringer Ingelheim
Conditions
Obesity
Interventions
COMBINATION_PRODUCT:survodutide; COMBINATION_PRODUCT:Placebo
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
REGISTRY:U1111-1288-9400; REGISTRY:2022-502529-17-00

Registered primary outcomes

  • Percentage change in body weight from baseline to Week 76 [Baseline and at Week 76]
  • Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76 [Baseline and at Week 76]

Linked records (4)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0008183Survodutide Once Weekly for the Treatment of Adults with Obesity.
le Roux CW, The New England journal of medicine
2026Randomized trialPMID 42253238DOIcites ClinicalTrials.gov:NCT06066515; registry reference DERIVED:42253238
R0013478Survodutide for treatment of obesity: Baseline characteristics of participants in a randomized, double-blind, placebo-controlled, phase 3 trial (SYNCHRONIZE™-1).
le Roux CW, Diabetes, obesity & metabolism
2026Randomized trialPMID 41187967DOIcites ClinicalTrials.gov:NCT06066515; registry reference DERIVED:41187967
R0056531Essai de phase 3 du survodutide administré une fois par semaine pour le traitement de l’obésité chez l’adulte : SYNCHRONIZE™-1
Emmanuel Disse, Annales d Endocrinologie
2026Other trialDOIcites ClinicalTrials.gov:NCT06066515
R0015290Survodutide for treatment of obesity: rationale and design of two randomized phase 3 clinical trials (SYNCHRONIZE™-1 and -2).
Wharton S, Obesity (Silver Spring, Md.)
2025ProtocolPMID 39495965DOIcites ClinicalTrials.gov:NCT06066515