Study S000475

A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD

ClinicalTrials.gov record

Registration

Registration: NCT06077864
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 5531
Start: 2023-11-20
Primary completion: 2026-06-01
Lead sponsor: Boehringer Ingelheim
Conditions: Obesity
Interventions: COMBINATION_PRODUCT:survodutide; COMBINATION_PRODUCT:Placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: REGISTRY:2022-502442-27-00; REGISTRY:U1111-1289-0174

Registered primary outcomes

Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority) [up to Week 114]

Linked records (1)

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.

Record	Title	Year	Design	Identifiers	Link basis
R0007859	Survodutide for the Treatment of Obesity: Rationale and Design of the SYNCHRONIZE Cardiovascular Outcomes Trial. Kosiborod MN, JACC. Heart failure	2024	Protocol	PMID 39453356 DOI	cites ClinicalTrials.gov:NCT06077864; registry reference DERIVED:39453356