Tirzepatide for maintenance of bodyweight reduction in people with obesity in the USA (SURMOUNT-MAINTAIN): a multicentre, double-blind, randomised, placebo-controlled trial
An erratum to this article was published (Lancet, 6 Jun 2026 ↗)
Authors' conclusion
In adults with obesity, long-term treatment is often necessary to maintain bodyweight reduction and its associated cardiometabolic benefits. In the SURMOUNT-MAINTAIN trial, continuing tirzepatide at MTD maintained bodyweight reduction and health-related benefits. Reducing to 5 mg tirzepatide might provide a valuable alternative to discontinuation, although individuals' treatment response might vary. Together, these findings support the importance of ongoing therapy for long-term obesity management and provide evidence to inform individualised, patient-centred obesity care.
Study context
- Population
- Adults (≥18 years) with BMI ≥30 kg/m² or ≥27 kg/m² with ≥1 weight-related comorbidity and ≥1 unsuccessful dietary effort, who completed a 60-week tirzepatide maximum tolerated dose (MTD) weight-loss period; 20 sites in the USArandomised at week 60
- Participants
- 378 adults
- Comparison
- Continuing tirzepatide MTD or reducing to tirzepatide 5 mg vs switching to placebo
- Tirzepatide MTDn = 140
- 5 mg tirzepatiden = 144
- Placebon = 94reference
- Primary endpoint
- Percentage change in bodyweight (modified treatment-regimen estimand)
- Follow-up
- Baseline to week 112
Methodological detailsphase 3b, multicentre, double-blind, placebo-controlled, 60-week open-label weight-loss period then 52-week double-blind maintenance period, 345 (91%) of 378 participants completed the study
- Phase 3b
- Multicentre
- Double-blind
- Placebo-controlled
- 60-week open-label weight-loss period then 52-week double-blind maintenance period
- 345 (91%) of 378 participants completed the study
Primary result
As reported in the abstract
Tirzepatide MTD
−21.9
95% CI −23.5–-20.3 · %
5 mg tirzepatide
−16.6
95% CI −18.0–-15.1 · %
Placebo
−9.9
95% CI −11.1–-8.8 · %
- Tirzepatide MTD
- estimated treatment difference −12.0 % (95% CI −13s·8 to −10.1); P < 0.0001 for all comparisons
Further findings
Received rescue therapy (among participants who regained ≥50% of lost bodyweight)
- Received rescue therapy (among participants who regained ≥50% of lost bodyweight): observed; denominators 138, 142 and 90
Safety
Adverse events
- Most common AEs with tirzepatide were gastrointestinal, mostly mild to moderate and mostly during dose escalation
Original publication
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