18+ · Research Use Only · Not for Human Consumption

Retatrutide · Phase 3 · Completed

TRIUMPH-3

In TRIUMPH-3, a phase 3 trial of retatrutide in adults with severe obesity (BMI of 35 or more) and established cardiovascular disease, with or without type 2 diabetes (n=1,949), mean body weight fell 21.6% on 9 mg and 22.6% on 12 mg over 80 weeks, against 3.2% on placebo (efficacy estimand; Eli Lilly topline release, 23 July 2026).

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Results

TRIUMPH-3: mean percent change in body weight by armTRIUMPH-3 efficacy estimand9 mg-21.6%12 mg-22.6%Placebo-3.2%
Mean percent change in body weight by arm, as each source reports it. Bars from different trials are not a head-to-head comparison: populations, durations and estimands differ.

In a pre-specified in-study analysis of time to first MACE-5 event, pooled retatrutide against placebo had a hazard ratio of 0.82 (95% CI 0.55 to 1.22).

Side effects reported

In TRIUMPH-3, discontinuation because of adverse events was 9.8% on 9 mg and 13.5% on 12 mg, against 4.8% on placebo. The most frequently reported adverse events were diarrhoea in 30.1% on 9 mg and 24.4% on 12 mg against 8.7% on placebo, nausea in 21.7% on 9 mg and 22.4% on 12 mg against 5.8% on placebo, constipation in 18.0% on 9 mg and 15.7% on 12 mg against 7.1% on placebo and decreased appetite in 13.5% on 9 mg and 14.5% on 12 mg against 3.0% on placebo.

Event9 mg12 mgPlacebo
Discontinuation for adverse events9.8%13.5%4.8%
Diarrhoea30.1%24.4%8.7%
Nausea21.7%22.4%5.8%
Constipation18.0%15.7%7.1%
Decreased appetite13.5%14.5%3.0%
Dysesthesia6.4%6.4%1.3%
Urinary tract infection6.1%7.0%5.3%

Design

Trial design and sources

Compound
Retatrutide
Phase
3
Population
Adults with severe obesity (BMI of 35 or more) and established cardiovascular disease, with or without type 2 diabetes
Participants randomised
1,949
Duration
80 weeks
Primary endpoint
Percent change in body weight from baseline at 80 weeks
Estimand
efficacy
Read out
23 July 2026
  • Eli Lilly topline release, 23 July 2026 open · checked 23 September 2026
  • ClinicalTrials.gov NCT05882045 open · checked 23 September 2026
  • Registry: NCT05882045

Questions

TRIUMPH-3, answered

What did TRIUMPH-3 find?

In TRIUMPH-3, a phase 3 trial of retatrutide in adults with severe obesity (BMI of 35 or more) and established cardiovascular disease, with or without type 2 diabetes (n=1,949), mean body weight fell 21.6% on 9 mg and 22.6% on 12 mg over 80 weeks, against 3.2% on placebo (efficacy estimand; Eli Lilly topline release, 23 July 2026).

What side effects were reported in TRIUMPH-3?

In TRIUMPH-3, discontinuation because of adverse events was 9.8% on 9 mg and 13.5% on 12 mg, against 4.8% on placebo. The most frequently reported adverse events were diarrhoea in 30.1% on 9 mg and 24.4% on 12 mg against 8.7% on placebo, nausea in 21.7% on 9 mg and 22.4% on 12 mg against 5.8% on placebo, constipation in 18.0% on 9 mg and 15.7% on 12 mg against 7.1% on placebo and decreased appetite in 13.5% on 9 mg and 14.5% on 12 mg against 3.0% on placebo.