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Human evidence record · Tirzepatide

SURMOUNT-MAINTAIN: Tirzepatide for maintenance of body-weight reduction in adults with obesity

Estimated body-weight change from baseline to week 112 was -21.9% with continued maximum tolerated dose, -16.6% after reduction to 5 mg, and -9.9% after switching to placebo.

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Human evidence record

What this study tells us

This was an early human study designed mainly to measure exposure, tolerability or a preliminary signal. Without stronger blinded controls, it should not be treated as definitive proof of benefit.

Who was studied?

Adults with obesity or overweight plus a weight-related comorbidity, without diabetes

How many?

n=441 enrolled; 378 randomized at week 60

What happened?

Estimated body-weight change from baseline to week 112 was -21.9% with continued maximum tolerated dose, -16.6% after reduction to 5 mg, and -9.9% after switching to placebo.

What stops us overclaiming?

All participants first received open-label tirzepatide; the randomized phase tests continuation or dose reduction versus withdrawal rather than initial efficacy in treatment-naive participants.

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Key result

Estimated body-weight change from baseline to week 112 was -21.9% with continued maximum tolerated dose, -16.6% after reduction to 5 mg, and -9.9% after switching to placebo.

Study details

Study designRandomized, double-blind, placebo-controlled Phase 3b trial after open-label weight reduction
PhasePhase 3b
PopulationAdults with obesity or overweight plus a weight-related comorbidity, without diabetes
Sample size441 enrolled; 378 randomized at week 60
RouteSubcutaneous
Regimen / exposureAfter 60 weeks of tirzepatide maximum tolerated dose, participants continued 10/15 mg, reduced to 5 mg, or switched to placebo
Duration112 weeks total; 52-week randomized maintenance period
ComparatorPlacebo switch after initial tirzepatide treatment
Primary endpoint / questionPercentage change in body weight from baseline to week 112 and maintenance of prior weight reduction
Safety resultThe most common tirzepatide adverse events were gastrointestinal and mostly mild to moderate, occurring mainly during dose escalation.
Key limitationsAll participants first received open-label tirzepatide; the randomized phase tests continuation or dose reduction versus withdrawal rather than initial efficacy in treatment-naive participants.
Registry / identifierPMID 42119587 / NCT06047548