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

What Was Tested

The trial (phase 3) is built around Tirzepatide for fat loss, obesity & body recomposition.

Many people who have bariatric (weight-loss) surgery do not lose as much weight as expected, or they regain weight over time.

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).

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

Participants will receive matching placebo (identical prefilled syringe) once weekly by subcutaneous injection, self-administered at home, following the same up-titration schedule and visit schedule as the tirzepatide arm, for a total of 52 weeks.

The registry classes the interventions as drug.

More on the Plan

A total of 70 participants will be randomized in a 1:1 ratio to receive either tirzepatide or matching placebo, administered once weekly by subcutaneous injection.

Randomization will be stratified by type of bariatric surgery, baseline BMI category, and time since surgery.

The primary objective is to assess the effect of tirzepatide versus placebo on the percentage change in body weight from baseline to week 52.

Participants will attend six study visits over 52 weeks (Weeks 0, 8, 16, 24, 36, and 52), including anthropometric measurements, vital signs, laboratory safety assessments, and adverse event monitoring.

Who Took Part

The registry lists 70 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults (male or female) aged ≥18 years. History of bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) performed ≥12 months before enrollment. Current BMI ≥30 kg/m². In the investigator's opinion, well-motivated, capable, and willing to comply with study procedures. For female participants:.

The full record lists 15 inclusion and 23 exclusion criteria; among the exclusions: use of a glp-1 receptor agonist (glp-1 ra) or any other glp-1-based therapy at present or within the past 6 months; have a planned surgical treatment, endoscopic and/or device-based therapy for obesity during the period of the study; type 2 diabetes currently treated with insulin or sulfonylureas.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The fat loss, obesity & body recomposition participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2027-01 with completion listed for 2028-12.

It ran at 3 sites in Portugal (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage Change in Body Weight from Baseline to Week 52 (time frame: Baseline (Week 0) to Week 52).

It also tracked 15 secondary outcomes, for example Change in Body Weight, Change in Body Mass Index (BMI), Change in Waist Circumference, Change in Blood Pressure, Change in Glycated Hemoglobin (HbA1c) and Change in Fasting Glucose.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 70 people with fat loss, obesity & body recomposition.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, Fat loss, obesity & body recomposition research.