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TRIUMPH-9: Retatrutide in Obesity or Overweight
NCT07357415Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Jan 2026
- Primary completion
- Oct 2028
- Countries
- 3
- Sponsor
- Eli Lilly and Company
- Modality
- Peptides, Small Molecules
- Drugs
- retatrutide
- Conditions
- obesity
01
Overview
Phase 3, randomised, double-blind trial of retatrutide in obesity (3 arms), sponsored by Eli Lilly and Company. Primary endpoint: Percent Change from Baseline in Body Weight at 104 weeks. Started Jan 2026; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Retatrutide Dose Escalation 1
Participants will receive retatrutide subcutaneously (SC) following dose escalation scheme 1.
Retatrutide Dose Escalation 2
Participants will receive retatrutide subcutaneously (SC) following dose escalation scheme 2.
Retatrutide Dose Escalation 3
Participants will receive retatrutide subcutaneously (SC) following dose escalation scheme 3.
03
Who it enrols
Participants must have a BMI >= 30, or >= 27 with at least one weight-related condition, and at least one unsuccessful diet attempt. Excludes patients with type 1 or 2 diabetes, recent significant weight change, prior/planned obesity surgery, history of MTC/MEN-2, recent cardiovascular events, NYHA Class IV heart failure, or history of pancreatitis.
04
Endpoints
Primary
Percent Change from Baseline in Body Weight
Secondary
Change from Baseline in Waist Circumference
Percent Change from Baseline in Triglycerides
Change from Baseline in Systolic Blood Pressure
Percent Change from Baseline in High Sensitivity C-Reactive Protein
Change from Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Total Score
Overall Treatment Satisfaction with Medication for Obesity Scores
Steady state Average Trough PK Concentration
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