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Tirzepatide 2023-09-20 ClinicalTrials

Tirzepatide Assessed for Sustained Weight Loss Maintenance in Obese/Overweight Adults Post-Reduction

A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Background

Obesity and overweight with related comorbidities represent a significant global health challenge, increasing risks for type 2 diabetes, cardiovascular disease, and certain cancers. While various interventions can induce initial weight loss, maintaining this reduction long-term remains a major hurdle, often leading to weight regain due to complex physiological adaptations. Current anti-obesity medications and lifestyle programs frequently struggle with sustained efficacy. Tirzepatide, a dual GLP-1R and GIPR agonist, has demonstrated substantial weight loss in previous trials, prompting investigation into its potential role in preventing weight regain and supporting long-term weight management. This study aims to address the critical gap in sustained weight reduction strategies.

Study Design

This randomized, double-blind, placebo-controlled Phase 3 clinical trial (SURMOUNT-3, N=806) enrolled participants with obesity or overweight and weight-related comorbidities (excluding type 2 diabetes) who had already achieved significant weight loss through an intensive lifestyle intervention. Following an initial 12-week lead-in phase of lifestyle intervention, eligible participants were randomized to receive either tirzepatide (doses up to 15 mg once weekly via subcutaneous injection) or placebo for a subsequent 72-week treatment period. The primary endpoint is the percentage change in body weight from randomization to the end of the treatment period, evaluating the maintenance of weight reduction. Secondary endpoints include the proportion of participants achieving specific weight loss thresholds and changes in cardiometabolic parameters.

Results

As this is a description of an ongoing or recently completed study, specific efficacy and safety results are not yet publicly available. The trial aims to determine if tirzepatide can significantly improve the maintenance of body weight reduction compared to placebo in individuals who have already achieved initial weight loss. Previous studies with tirzepatide have shown substantial body weight reductions, with participants achieving up to 22.5% mean weight loss from baseline in other populations. The expectation is that tirzepatide's dual GLP-1R and GIPR agonism will modulate appetite and energy expenditure, thereby preventing weight regain. Safety and tolerability profiles, including rates of gastrointestinal adverse events, will also be thoroughly assessed. > The primary outcome will quantify the difference in mean percentage body weight change from randomization between the tirzepatide and placebo groups, providing crucial data on its long-term weight maintenance potential.


Source: clinicaltrials:NCT06047548 · Ingested 2026-06-09 · Digest: gemini-2.5-flash