The SURMOUNT-MAINTAIN study is testing if people who have already lost weight on the highest tolerated dose of tirzepatide can keep that loss by either staying on the same dose, dropping to a lower dose, or stopping the drug altogether. It’s a 52‑week, double‑blind trial with adults who have obesity but not diabetes, and it will measure how much of the original weight loss is kept after a year. The results will tell whether a lower maintenance dose can still work, which could help people plan long‑term use of tirzepatide for weight control.

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. 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. 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. 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. ClinicalTrials.gov identifier: NCT06047548.