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

Authors

• Deborah B Horn
• Louis J Aronne
• Sean Wharton
• Harold E Bays
• Elisa Gomez-Valderas
• Avigdor D Arad
• Palash Sharma
• Julia P Dunn
• Cagri Senyucel
• Clare J Lee

Language

English

Publication Date

10-1-2025

Journal

Obesity

DOI

10.1002/oby.70014

PMID

40916045

PMCID

PMC12477106

PubMedCentral® Posted Date

10-27-2025

PubMedCentral® Full Text Version

Post-print

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.

Keywords

Humans, Female, Male, Obesity, Double-Blind Method, Middle Aged, Weight Loss, Adult, Anti-Obesity Agents, Body Mass Index, Treatment Outcome, Clinical Trials, Phase III as Topic, Maximum Tolerated Dose, Tirzepatide, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, clinical care, diagnosis, obesity medication, obesity treatment, pharmacotherapy, antiobesity medication, obesity, obesity management medication, SURMOUNT‐MAINTAIN, tirzepatide

Published Open-Access

yes

Recommended Citation

Horn, Deborah B; Aronne, Louis J; Wharton, Sean; et al., "Tirzepatide for the Maintenance of Body Weight Reduction: Rationale, Design, and Baseline Characteristics of SURMOUNT-MAINTAIN" (2025). Faculty, Staff and Student Publications. 4514.
https://digitalcommons.library.tmc.edu/uthmed_docs/4514