Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial
An erratum to this article was published (Nat Med, Jun 2024 ↗)
Primary result · Additional mean % weight change from randomization (coprimary)Result — go to the resultEstimated treatment difference −20.8 percentage points 95% CI −23.2% to −18.5%Authors' conclusion
Tirzepatide provided substantial additional reduction in body weight in participants who had achieved ≥5.0% weight reduction with intensive lifestyle intervention.
Study context
- Population
- Adults with BMI ≥30 or ≥27 kg/m² and ≥1 obesity-related complication (excluding diabetes) who achieved ≥5.0% weight reduction after a 12-week intensive lifestyle interventionrandomized 1:1
- Participants
- 579 adults
- Comparison
- Tirzepatide MTD (10 or 15 mg) vs placebo once weekly after intensive lifestyle intervention
- Primary endpoint
- Coprimary: additional mean % weight change from randomization; % of participants achieving additional weight reduction ≥5%
- Follow-up
- Week 72
Methodological detailsdouble-blind, placebo-controlled
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Additional mean % weight change from randomization (coprimary)
Estimated treatment difference
−20.8 percentage points
95% CI −23.2% to −18.5%
P < 0.001
Change by group
Tirzepatide
−18.4
mean · SE 0.7 · %
Placebo
2.5
mean · SE 1.0 · %
Tirzepatidevs Placebo
estimated treatment difference −20.8 percentage points (95% CI −23.2% to −18.5%); P < 0.001
Further findings
| Outcome | Tirzepatide | Placebo | OR (95% CI) | P value |
|---|---|---|---|---|
| Additional weight reduction ≥5% (coprimary) · week 72Coprimary endpoint · intention-to-treat population | 87.5% (SE 2.2) | 16.5% (SE 3.0) | 34.6% (19.2%–62.6%) | P < 0.001 |
Safety
Adverse events
- Most common AEs with tirzepatide were gastrointestinal, mostly mild to moderate
Original publication
Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. Published 15 October 2023. doi:10.
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