drugset / Trial / NCT07829198

Efficacy of Tirzepatide for Weight Management in Patients With Suboptimal Weight Loss After Bariatric Surgery: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

NCT07829198 ↗

Phase 3 Not yet recruiting 70 enrolled University of Porto Eli Lilly and Company · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Many people who have bariatric (weight-loss) surgery do not lose as much weight as expected, or they regain weight over time. This study will test whether a medicine called tirzepatide can help these patients lose more weight and improve their overall health. Participants who had bariatric surgery at least one year ago and still have obesity with insufficient weight loss will be randomly assigned, like a coin flip, to receive either tirzepatide or a placebo (an inactive injection that looks the same). Neither participants nor study staff will know who is receiving which treatment. Participants will inject the study medicine or placebo once a week for 52 weeks, starting at a low dose that is gradually increased. During the study, researchers will measure body weight, waist size, blood pressure, and blood tests related to metabolism and inflammation. Participants will also answer questionnaires about their quality of life. The main goal is to find out whether tirzepatide leads to greater weight loss than placebo after one year of treatment.

Timeline

Start
2027-01
Primary completion
2028-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tirzepatide Peptide 15 mg Subcutaneous

Indications