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

IF 4.7 2区医学 Q1 ENDOCRINOLOGY & METABOLISM

Obesity Pub Date : 2025-09-07 DOI:10.1002/oby.70014

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

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引用次数: 0

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

Abstract Image

查看原文本刊更多论文

替西肽维持体重减轻：基本原理、设计和超越-维持的基线特征。

目的：surmount - maintenance旨在评估与安慰剂相比，减少替西肽剂量和/或继续使用最大耐受剂量（MTD）在维持替西肽MTD达到的体重（BW）降低方面的有效性和安全性。方法：这项3b期、多中心、随机、平行、双盲、安慰剂对照、52周的临床试验正在进行中，比较每周1次替西帕肽（5mg和/或MTD为15mg或10mg）与安慰剂治疗在最初60周开放标签的替西帕肽MTD减肥期（BMI≥30kg /m2或≥27kg /m2伴有≥1种肥胖相关合并症，2型糖尿病除外）中实现体重降低维持的效果。主要终点是在第112周达到体重平台的减肥期间体重减少的百分比(即：结果：参与者大多数是女性（65%），平均±SD年龄为47±13岁，体重114±27 kg， BMI 40±8 kg/m2，腰围119±18 cm。结论：surmount - maintenance试验将评估减少或继续使用替西帕肽作为长期治疗选择是否有助于维持最初使用替西帕肽MTD而不是改用安慰剂所达到的降低的体重。综上所述，本研究可能提供额外的证据，以帮助制定以患者为中心的策略，以维持肥胖成人体重的降低。试验注册：ClinicalTrials.gov标识符：NCT06047548。

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来源期刊

Obesity 医学-内分泌学与代谢

CiteScore

11.70

自引率

1.40%

发文量

261

审稿时长

2-4 weeks

期刊介绍： Obesity is the official journal of The Obesity Society and is the premier source of information for increasing knowledge, fostering translational research from basic to population science, and promoting better treatment for people with obesity. Obesity publishes important peer-reviewed research and cutting-edge reviews, commentaries, and public health and medical developments.