Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss

Plain-language guide to NCT06734273: early phase 1 randomized trial of Tirzepatide, fat loss, obesity & body recomposition, 42 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT06734273
Phase: early phase 1
Status: active, not recruiting
Start: 2025-03-10
Completion (planned or actual): 2027-09
Participants: 42 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Obesity and Obesity-related Medical Conditions
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this early phase 1 trial, researchers set out to test Tirzepatide for fat loss, obesity & body recomposition.

It had two arms (groups): SG-T: sleeve gastrectomy with tirzepatide (experimental) and SG-A: sleeve gastrectomy alone (active comparator).

In this study the control group (n=21) are patients who will undergo sleeve gastrectomy alone.

The registry classes the interventions as drug and procedure.

Who Took Part

Enrollment: 42 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Adult 18 to 65 years of age. Body Mass Index \>35 with comorbidity of Type 2 Diabetes and/or Hypertension and/or Hyperlipidemia and/or Obstructive Sleep Apnea OR Body Mass Index \>40 with or without comorbidity. Undergoing primary sleeve gastrectomy.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: prior metabolic and bariatric surgery; prior use of glp-1 agonist; prior history of pancreatitis.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

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

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-03-10 with completion listed for 2027-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Weight Loss (time frame: 12 months after surgery).

It also tracked 11 secondary outcomes, for example Weight Loss, Type 2 Diabetes, Type 2 Diabetes, High Blood Pressure, High Blood Pressure and High Cholesterol.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Tirzepatide in 42 people with fat loss, obesity & body recomposition.

Its status is active not 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.

Our Notes on the Compound

Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.