LivingGLP1
Study S002304

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 and Type 2 Diabetes Mellitus

Registration

Registration
NCT06066528
Acronym
SYNCHRONIZE™-2
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
QUADRUPLE
Status
COMPLETED
Enrollment
755
Start
2023-11-27
Primary completion
2025-12-12
Lead sponsor
Boehringer Ingelheim
Conditions
Obesity; Diabetes Mellitus, Type 2
Interventions
COMBINATION_PRODUCT:Survodutide; COMBINATION_PRODUCT:Placebo
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
REGISTRY:2022-502531-18-00; REGISTRY:U1111-1289-0247

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 (3)

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
R0007237Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes.
Wharton S, The New England journal of medicine
2026Randomized trialPMID 42820639DOIcites ClinicalTrials.gov:NCT06066528; registry reference DERIVED:42820639
R0013326Baseline characteristics in the SYNCHRONIZE™-2 randomized phase 3 trial of survodutide, a glucagon receptor/GLP-1 receptor dual agonist, for obesity in people with type 2 diabetes.
Wharton S, Diabetes, obesity & metabolism
2026Randomized trialPMID 41216778DOIcites ClinicalTrials.gov:NCT06066528; registry reference DERIVED:41216778
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:NCT06066528