Tirzepatide for the Maintenance of Body Weight Reduction: Rationale, Design, and Baseline Characteristics of SURMOUNT ‐ MAINTAIN

ABSTRACT Objective SURMOUNT‐MAINTAIN aims to evaluate the efficacy and safety of reducing the tirzepatide dose and/or continuing the maximum tolerated dose (MTD) versus placebo in maintaining body weight (BW) reduction achieved with tirzepatide MTD. Methods This Phase 3b, multicenter, randomized, parallel‐arm, double‐blinded, placebo‐controlled, 52‐week clinical trial is in progress comparing treatment with once weekly tirzepatide (5 mg and/or MTD of 15 mg or 10 mg) versus placebo in achieving BW reduction maintenance from the initial 60‐week open‐label weight‐loss period on tirzepatide MTD, in adults with obesity (BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with ≥ 1 obesity‐related comorbidity, excluding type 2 diabetes). The primary endpoint is percent maintenance of BW reduction achieved during the weight‐loss period at Week 112 among those who reached a BW plateau (i.e., < 5% BW change) between Weeks 48 and 60. Results Participants are mostly female (65%) with a mean ± SD age of 47 ± 13 years, BW 114 ± 27 kg, BMI 40 ± 8 kg/m2, and waist circumference 119 ± 18 cm. Conclusions The SURMOUNT‐MAINTAIN trial will evaluate whether reducing or continuing the tirzepatide dose as a long‐term treatment option may help maintain the reduced BW initially achieved with tirzepatide MTD versus switching to placebo. Combined, this study may provide additional evidence to help tailor patient‐centered strategies for maintenance of BW reduction in adults living with obesity. Trial Registration ClinicalTrials.gov identifier: NCT06047548 image