The TRIUMPH Phase 3 Program

Eli Lilly's Phase 3 program for retatrutide is named TRIUMPH. It consists of multiple large-scale trials designed to establish safety and efficacy across different patient populations and to support regulatory approval worldwide, including Health Canada.

Phase 2 results (published June 2023)

Landmark Publication Jastreboff AM, et al. "Triple-Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial." New England Journal of Medicine 2023; 389:514-526.

The Phase 2 trial enrolled 338 adults with obesity and demonstrated:

  • Weight loss: Mean reduction up to ~24.2% at 48 weeks (12 mg dose group) vs ~2.1% for placebo
  • Responder rates: Over 90% of participants achieved at least 5% weight loss in the higher dose groups
  • ~50% of participants on 12 mg achieved ≥25% weight reduction
  • Side effects: Mostly gastrointestinal (nausea, diarrhea, vomiting), mild to moderate, improved over time
Cross-trial comparison caution: These results cannot be directly compared to other drugs' Phase 2/3 results because of differences in patient populations, trial protocols, and background therapies. Head-to-head trials are needed for valid comparisons.

TRIUMPH-1: Obesity with weight-related comorbidities

Population: Adults with obesity or overweight with at least one weight-related comorbidity (excluding diabetes).

Design: Randomized, double-blind, placebo-controlled. Testing multiple doses of retatrutide vs placebo. Primary endpoint: percent body weight change at 72 weeks.

NCT05929066 | Status: Active, not recruiting | Results: May 2026 — up to 30.3% mean weight loss

TRIUMPH-2: Type 2 diabetes with obesity/overweight

Population: Adults with type 2 diabetes and obesity or overweight.

Design: Randomized, double-blind. Retatrutide vs placebo. Primary endpoint: change in HbA1c and percent body weight change.

NCT05929079 | Status: Active, not recruiting | Expected: May 2026

TRIUMPH-3: Cardiovascular outcomes (CVOT)

Population: Adults with obesity and established cardiovascular disease.

Design: Long-term cardiovascular outcomes trial. Primary endpoint: time to first major adverse cardiovascular event (MACE).

NCT06383390 (TRIUMPH-OUTCOMES) | Status: Active, not recruiting | 22 Canadian sites | Expected: 2029

TRIUMPH-4: Knee osteoarthritis with obesity

Population: Adults with obesity and knee osteoarthritis.

Design: Retatrutide vs placebo. Primary endpoints: change in knee pain and physical function, plus percent weight change.

NCT05931367 | Status: Completed (Nov 2025) | 10 Canadian sites

TRIUMPH-5: Head-to-head vs semaglutide

Population: Adults with obesity or overweight with weight-related comorbidities.

Design: Retatrutide directly compared against semaglutide 2.4 mg (Wegovy).

NCT06260722 | Status: Active, not recruiting | 12 Canadian sites | Expected: Aug 2026

Canadian clinical trial sites

Several Canadian sites are participating in the TRIUMPH program. To find currently recruiting locations:

  1. Visit ClinicalTrials.gov — retatrutide in Canada
  2. Filter by "Recruiting" status
  3. Contact the study site directly or ask your physician for a referral

Participation in clinical trials is free. You receive the investigational medication and monitoring at no cost. Travel to study visits may be required.

Expected timeline: Phase 3 results are expected to begin reporting in 2025-2026. If positive, Eli Lilly could file for regulatory approval (including Health Canada NOC) within months of key data readouts. Actual approval timelines depend on regulatory review.