LivingGLP1
Study S001365

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and Major Adverse Kidney Events in Participants With Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

ClinicalTrials.gov record

Registration

Registration
NCT06383390
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
ACTIVE_NOT_RECRUITING
Enrollment
10000
Start
2024-04-30
Primary completion
2029-02
Lead sponsor
Eli Lilly and Company
Conditions
Atherosclerotic Cardiovascular Disease (ASCVD); Chronic Kidney Disease (CKD)
Interventions
DRUG:Retatrutide; DRUG:Placebo
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
OTHER:J1I-MC-GZBO; OTHER:2023-508630-34-00; NIH:2023

Registered primary outcomes

  • Time to First Occurrence of Composite Endpoints [Randomization up to Study Completion (Approximate 248 Weeks)]
  • Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), ≥ 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death [Randomization up to Study Completion (Approximate 248 Weeks)]

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.
RecordTitleYearDesignIdentifiersLink basis
R0012093Rationale, design and baseline characteristics of the TRANSCEND-CKD trial of retatrutide in patients with chronic kidney disease.
Heerspink HJL, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
2026ProtocolPMID 41160422DOIcites ClinicalTrials.gov:NCT06383390; registry reference DERIVED:41160422