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

NCT07829198 · Not yet recruiting

Last updated 2026-09-22

This clinical trial tests whether the medication tirzepatide helps people who have not lost enough weight after weight-loss surgery to further reduce their body weight over 52 weeks.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 70 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2027-01 · est. completion 2028-12

Where 3 sites · Portugal

What this study is testing ClinicalTrials.gov NCT07829198 ↗

Description as written by the study sponsor.

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.

Treatments tested

Tirzepatide Drug

Dual GIP/GLP-1 receptor agonist supplied as a prefilled syringe (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg) for subcutaneous injection, manufactured by Eli Lilly and Company. Self-administered once weekly by the participant in the abdomen, thigh, or upper arm, with rotating injection sites. Dose up-titrated every 4 weeks in 2.5 mg increments, up to a maximum of 15 mg or the maximum tolerated dose, for a total treatment duration of 52 weeks.
Placebo Drug

Matching placebo, supplied as a prefilled syringe identical in appearance to the tirzepatide syringe, manufactured by Eli Lilly and Company. Self-administered once weekly by subcutaneous injection, following the same up-titration schedule, injection sites, and visit schedule as the tirzepatide arm, for a total of 52 weeks

Main thing measured	Percentage Change in Body Weight from Baseline to Week 52
Sponsor	Universidade do Porto
Conditions studied	Obesity
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07829198 ↗