18+ · Research Use Only · Not for Human Consumption
Retatrutide · Phase 3 · Completed
TRIUMPH-4
In TRIUMPH-4, a phase 3 trial of retatrutide in adults with obesity or overweight and knee osteoarthritis, without diabetes (n=445), mean body weight fell 26.4% on 9 mg and 28.7% on 12 mg over 68 weeks, against 2.1% on placebo (efficacy estimand; Eli Lilly topline release, 11 December 2025).
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Results
WOMAC pain fell 4.5 and 4.4 points from a baseline of 6.0 on 9 and 12 mg, against 2.4 on placebo.
Side effects reported
In TRIUMPH-4, discontinuation because of adverse events was 12.2% on 9 mg and 18.2% on 12 mg, against 4.0% on placebo. The most frequently reported adverse events were nausea in 38.1% on 9 mg and 43.2% on 12 mg against 10.7% on placebo, diarrhoea in 34.7% on 9 mg and 33.1% on 12 mg against 13.4% on placebo, constipation in 21.8% on 9 mg and 25.0% on 12 mg against 8.7% on placebo and vomiting in 20.4% on 9 mg and 20.9% on 12 mg against 0.0% on placebo.
| Event | 9 mg | 12 mg | Placebo |
|---|---|---|---|
| Discontinuation for adverse events | 12.2% | 18.2% | 4.0% |
| Nausea | 38.1% | 43.2% | 10.7% |
| Diarrhoea | 34.7% | 33.1% | 13.4% |
| Constipation | 21.8% | 25.0% | 8.7% |
| Vomiting | 20.4% | 20.9% | 0.0% |
| Decreased appetite | 19.0% | 18.2% | 9.4% |
| Dysesthesia | 8.8% | 20.9% | 0.7% |
Design
Trial design and sources
- Compound
- Retatrutide
- Phase
- 3
- Population
- Adults with obesity or overweight and knee osteoarthritis, without diabetes
- Participants randomised
- 445
- Duration
- 68 weeks
- Primary endpoint
- Co-primary: percent change in body weight and change in WOMAC pain score at 68 weeks
- Estimand
- efficacy
- Read out
- 11 December 2025
Questions
TRIUMPH-4, answered
What did TRIUMPH-4 find?
In TRIUMPH-4, a phase 3 trial of retatrutide in adults with obesity or overweight and knee osteoarthritis, without diabetes (n=445), mean body weight fell 26.4% on 9 mg and 28.7% on 12 mg over 68 weeks, against 2.1% on placebo (efficacy estimand; Eli Lilly topline release, 11 December 2025).
What side effects were reported in TRIUMPH-4?
In TRIUMPH-4, discontinuation because of adverse events was 12.2% on 9 mg and 18.2% on 12 mg, against 4.0% on placebo. The most frequently reported adverse events were nausea in 38.1% on 9 mg and 43.2% on 12 mg against 10.7% on placebo, diarrhoea in 34.7% on 9 mg and 33.1% on 12 mg against 13.4% on placebo, constipation in 21.8% on 9 mg and 25.0% on 12 mg against 8.7% on placebo and vomiting in 20.4% on 9 mg and 20.9% on 12 mg against 0.0% on placebo.