SURMOUNT-MAINTAIN
Tirzepatide for maintenance of bodyweight reduction in people with obesity in the USA (SURMOUNT-MAINTAIN): a multicentre, double-blind, randomised, placebo-controlled trial.
Horn DB, Aronne LJ, Wharton S, Bays HE, le Roux CW, Srinath R, Gomez-Valderas E, Arad AD, Das S, Dunn JP, Ribeiro A, Glass LC, Lee CJ. · Lancet (London, England)
Study record
- Population
441 adults entered the lead-in; 378 were randomized after 60 weeks: 140 continued maximum tolerated dose, 144 reduced to 5 mg and 94 switched to placebo. Maintenance safety populations were 139, 142 and 91, respectively; 345 randomized participants completed the study.
Read source · Abstract-level extractionPrimary abstract — Methods and Results- Formulation
Exact preparation and device details are not verified in this extraction. Trial drug identity does not establish equivalence to research products.
Inspect extraction gap · Abstract-level extractionPrimary abstract — intervention description; full-text formulation unavailable- Route
Subcutaneous injection.
Read source · Abstract-level extractionPrimary abstract — Methods and Results- Dose & frequency
Continue tolerated 10/15 mg weekly, reduce to 5 mg, or switch to placebo. From week 84, rescue tirzepatide was permitted after regaining more than 50% of lost weight; this is a trial rule, not a personal tapering schedule.
Read source · Abstract-level extractionPrimary abstract — Methods and Results- Study design
Phase 3b randomized double-blind maintenance trial; continued dose, reduced dose or placebo.
Read source · Abstract-level extractionPrimary abstract — Methods and Results- Duration
60-week lead-in plus 52-week maintenance.
Read source · Abstract-level extractionPrimary abstract — Methods and Results- Reported findings
Baseline-to-week-112 weight change: −21.9%, −16.6%, −9.9% for continued, reduced dose and placebo; includes the common lead-in.
Read source · Abstract-level extractionPrimary abstract — Methods and Results- Adverse events
Mostly mild/moderate gastrointestinal events, concentrated during escalation.
Read source · Abstract-level extractionPrimary abstract — Methods and Results- Monitoring
Full safety-assessment schedule not verified; inspect the primary report and registry.
Inspect extraction gap · Abstract-level extractionPrimary abstract; detailed monitoring schedule unavailable
What it supports
Addresses SURMOUNT-MAINTAIN outcomes in its specified population and comparison.
What it does not establish
The primary modified treatment-regimen estimand assumed no further assigned-treatment benefit after rescue, while including randomized participants regardless of discontinuation or prohibited medications. Weight changes include the common 60-week lead-in and are not maintenance-period losses alone. Selected lead-in completers; not a universal taper or cycling protocol. The registry has no posted results or attached protocol in the retrieved record; detailed formulation and monitoring remain unverified. A linked correction (PMID 42242249) exists; its exact scope has not been verified.
Funding
Eli Lilly funded the study (primary abstract).
Literature search cutoff: 2026-09-08 · Not independently clinically reviewed
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