18+ · Research use only
Tirzepatide · Phase 3 · Completed
SURMOUNT-4
In SURMOUNT-4, a phase 3 trial of tirzepatide in adults with BMI of 30 or more, or 27 or more with a weight-related complication, excluding diabetes (n=670), mean body weight changed by -5.5% on continued tirzepatide, weeks 36 to 88 over 88 weeks, against +14.0% on switched to placebo (treatment-regimen estimand; Aronne LJ et al. JAMA 2024 (SURMOUNT-4)).
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Updated 24 September 2026
Results
Side effects reported
In SURMOUNT-4, discontinuation because of adverse events was 1.8% on continued tirzepatide, weeks 36 to 88, against 0.9% on switched to placebo. The most frequently reported adverse events were diarrhoea in 10.7% on continued tirzepatide, weeks 36 to 88 against 4.8% on switched to placebo, nausea in 8.1% on continued tirzepatide, weeks 36 to 88 against 2.7% on switched to placebo and vomiting in 5.7% on continued tirzepatide, weeks 36 to 88 against 1.2% on switched to placebo.
| Event | Continued tirzepatide, weeks 36 to 88 | Switched to placebo |
|---|---|---|
| Discontinuation for adverse events | 1.8% | 0.9% |
| Diarrhoea | 10.7% | 4.8% |
| Nausea | 8.1% | 2.7% |
| Vomiting | 5.7% | 1.2% |
Design
Trial design and sources
- Compound
- Tirzepatide
- Phase
- 3
- Population
- Adults with BMI of 30 or more, or 27 or more with a weight-related complication, excluding diabetes
- Participants randomised
- 670
- Duration
- 88 weeks
- Primary endpoint
- Mean percent change in weight from week 36 (randomization) to week 88
- Estimand
- treatment-regimen
- Read out
- 1 January 2024
Withdrawal design: a 36-week open-label lead-in on tirzepatide, then randomisation to continue or switch to placebo. The switch-to-placebo arm regained weight. Adverse events shown are the double-blind period.
Questions
SURMOUNT-4, answered
What did SURMOUNT-4 find?
In SURMOUNT-4, a phase 3 trial of tirzepatide in adults with BMI of 30 or more, or 27 or more with a weight-related complication, excluding diabetes (n=670), mean body weight changed by -5.5% on continued tirzepatide, weeks 36 to 88 over 88 weeks, against +14.0% on switched to placebo (treatment-regimen estimand; Aronne LJ et al. JAMA 2024 (SURMOUNT-4)).
What side effects were reported in SURMOUNT-4?
In SURMOUNT-4, discontinuation because of adverse events was 1.8% on continued tirzepatide, weeks 36 to 88, against 0.9% on switched to placebo. The most frequently reported adverse events were diarrhoea in 10.7% on continued tirzepatide, weeks 36 to 88 against 4.8% on switched to placebo, nausea in 8.1% on continued tirzepatide, weeks 36 to 88 against 2.7% on switched to placebo and vomiting in 5.7% on continued tirzepatide, weeks 36 to 88 against 1.2% on switched to placebo.
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