Retatrutide for Obesity and Cardiovascular Disease
(TRIUMPH-3 Trial)
Recruiting at203 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Eli Lilly and Company
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing a medication called retatrutide in people who have both obesity and heart disease. The study will last over two years to see if the medication is safe and effective.
Research Team
C1
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Eligibility Criteria
This trial is for adults with obesity (BMI ≥35) and a history of cardiovascular disease, such as heart attack, stroke, or arterial disease. Participants should have tried to lose weight unsuccessfully before. They can't join if they've had recent significant weight changes, certain surgeries or acute cardiovascular events, use of weight loss drugs within the last 90 days, Type 1 diabetes, or specific hereditary cancer syndromes.Inclusion Criteria
Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²)
I have heart disease, including a past heart attack, stroke, or symptoms of poor blood flow in my legs.
You have tried to lose weight through dieting before, but it didn't work.
Exclusion Criteria
I or my family have a history of MTC or MEN-2.
I have had pancreatitis.
I have had or am planning to have surgery for weight loss.
See 4 more
Treatment Details
Interventions
- Placebo (Other)
- Retatrutide (Peptide)
Trial OverviewThe study tests Retatrutide's effectiveness and safety in reducing body weight for those with obesity and CVD. It compares Retatrutide given weekly against a placebo over approximately 113 weeks to see which is better at managing these conditions.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Retatrutide Dose 2Experimental Treatment1 Intervention
Participants will receive retatrutide SC.
Group II: Retatrutide Dose 1Experimental Treatment1 Intervention
Participants will receive retatrutide subcutaneously (SC).
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University