Phase 3 · NCT06383390
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
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
What this means
A verified peer-reviewed Phase 3 trial publication is linked. A registry record describes the study; it does not establish reported results.
Figure / record sourceLast verified 23 Oct 2026
Peer-reviewed publicationLast verified 13 Oct 2026
Registry record
Trial details
- Trial
- The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
- ClinicalTrials.gov ID
- NCT06383390
- Indication
- Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Eli Lilly and Company
- Enrolment
- 10,000
- Status
- Active, not recruiting
- Interventions
- Drug: Retatrutide; Drug: Placebo
- Comparator
- Placebo
- Eligible ages
- 45 Years – No maximum
- Locations
- 742 sites · Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Romania, Slovakia, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States
- Study start
- 30 Apr 2024
- Primary completion
- 1 Feb 2029
- Study completion
- 1 Feb 2029
Verification
- Last verified
- 23 Oct 2026
- Source
- ClinicalTrials.gov
- Registry last updated
- 8 Oct 2026
Endpoints
Primary
Time to First Occurrence of Composite Endpoints; 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
Secondary
Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3); Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF; Time to Occurrence of All-Cause Death; Time to First Occurrence of composite endpoint of ≥ 40% Sustained Decline in eGFR, End-Stage Renal Disease (ESRD), or Renal Death; Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR ≥30 mg/g (0.03 mg/mg) at baseline
Registry monitoring
Latest Trial Changes
| Field | Change | Detected | Source |
|---|---|---|---|
| Locations | 743 sites · Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Romania, Slovakia, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States→742 sites · Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Romania, Slovakia, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States | 25 Sept 2026 | ClinicalTrials.gov |
| Primary completion date | 2029-12-31→2029-02-01 | 4 Sept 2026 | ClinicalTrials.gov |
| Study completion date | Not yet confirmed→2029-02-01 | 4 Sept 2026 | ClinicalTrials.gov |
| Primary endpoints | Not yet confirmed→Time to First Occurrence of Composite Endpoints; 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 | 4 Sept 2026 | ClinicalTrials.gov |
| Recruitment status | Recruiting→Active, not recruiting | 4 Sept 2026 | ClinicalTrials.gov |