18+ · Research Use Only · Not for Human Consumption
Tirzepatide · Phase 3 · Completed
SURMOUNT-3
In SURMOUNT-3, a phase 3 trial of tirzepatide in adults with BMI of 30 or more, or 27 or more with at least one obesity-related complication (excluding diabetes), who achieved 5.0% or more weight reduction after a 12-week intensive lifestyle intervention (n=579), mean body weight changed by -18.4% on maximum tolerated dose (10 or 15 mg) over 72 weeks, against +2.5% on placebo (treatment-regimen estimand; Wadden TA et al. Nat Med 2023 (SURMOUNT-3)).
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Results
Side effects reported
In SURMOUNT-3, discontinuation because of adverse events was 10.5% on maximum tolerated dose (10 or 15 mg), against 2.1% on placebo. The most frequently reported adverse events were nausea in 39.7% on maximum tolerated dose (10 or 15 mg) against 14.0% on placebo, diarrhoea in 31.0% on maximum tolerated dose (10 or 15 mg) against 9.2% on placebo, constipation in 23.0% on maximum tolerated dose (10 or 15 mg) against 6.8% on placebo and vomiting in 18.1% on maximum tolerated dose (10 or 15 mg) against 1.4% on placebo.
| Event | Maximum tolerated dose (10 or 15 mg) | Placebo |
|---|---|---|
| Discontinuation for adverse events | 10.5% | 2.1% |
| Nausea | 39.7% | 14.0% |
| Diarrhoea | 31.0% | 9.2% |
| Constipation | 23.0% | 6.8% |
| Vomiting | 18.1% | 1.4% |
Design
Trial design and sources
- Compound
- Tirzepatide
- Phase
- 3
- Population
- Adults with BMI of 30 or more, or 27 or more with at least one obesity-related complication (excluding diabetes), who achieved 5.0% or more weight reduction after a 12-week intensive lifestyle intervention
- Participants randomised
- 579
- Duration
- 72 weeks
- Primary endpoint
- Coprimary: additional mean percent weight change from randomization to week 72, and percentage achieving additional weight reduction of 5% or more
- Estimand
- treatment-regimen
- Read out
- 15 October 2023
Enrolled participants who had lost 5% or more in a 12-week intensive lifestyle lead-in; figures are the additional change from randomisation. The placebo arm regained weight.
Questions
SURMOUNT-3, answered
What did SURMOUNT-3 find?
In SURMOUNT-3, a phase 3 trial of tirzepatide in adults with BMI of 30 or more, or 27 or more with at least one obesity-related complication (excluding diabetes), who achieved 5.0% or more weight reduction after a 12-week intensive lifestyle intervention (n=579), mean body weight changed by -18.4% on maximum tolerated dose (10 or 15 mg) over 72 weeks, against +2.5% on placebo (treatment-regimen estimand; Wadden TA et al. Nat Med 2023 (SURMOUNT-3)).
What side effects were reported in SURMOUNT-3?
In SURMOUNT-3, discontinuation because of adverse events was 10.5% on maximum tolerated dose (10 or 15 mg), against 2.1% on placebo. The most frequently reported adverse events were nausea in 39.7% on maximum tolerated dose (10 or 15 mg) against 14.0% on placebo, diarrhoea in 31.0% on maximum tolerated dose (10 or 15 mg) against 9.2% on placebo, constipation in 23.0% on maximum tolerated dose (10 or 15 mg) against 6.8% on placebo and vomiting in 18.1% on maximum tolerated dose (10 or 15 mg) against 1.4% on placebo.
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