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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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Updated 24 September 2026

Tirzepatide Explained: SURMOUNT, SURPASS and Philippines Status1:58Transcript and chapters

Results

SURMOUNT-3: mean percent change in body weight by armHorizontal bars, one group per trial: SURMOUNT-3, Maximum tolerated dose (10 or 15 mg) -18.4%, Placebo +2.5%.SURMOUNT-3treatment-regimen estimandMaximum tolerated dose (10 or 15 mg)-18.4%Placebo+2.5%
Mean percent change in body weight by arm, as each source reports it. Navy bars are the trial arms, grey bars the comparator. Bars from different trials are not a head-to-head comparison: populations, durations and estimands differ.

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.

EventMaximum tolerated dose (10 or 15 mg)Placebo
Discontinuation for adverse events10.5%2.1%
Nausea39.7%14.0%
Diarrhoea31.0%9.2%
Constipation23.0%6.8%
Vomiting18.1%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.

  • Wadden TA et al. Nat Med 2023 (SURMOUNT-3) open · checked 23 September 2026
  • ClinicalTrials.gov NCT04657016 open · checked 23 September 2026
  • Registry: NCT04657016

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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