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Effect of Tirzepatide and Bimagrumab on Body Composition, Insulin Sensitivity, and Bone in Adults With Obesity

Plain-language guide to NCT05933499: phase 2 randomized trial of Tirzepatide and Bimagrumab, 63 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05933499
Phase
phase 2
Status
recruiting participants
Start
2025-11-05
Completion (planned or actual)
2028-12-31
Participants
63 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Tirzepatide and Bimagrumab.

In adults with obesity seeking treatment, weight loss would ideally be composed almost exclusively of fat mass.

It had three arms (groups): Tirzepatide + bimagrumab (experimental), Tirzepatide + placebo (active comparator) and Bimagrumab + placebo (active comparator).

The registry classes the interventions as behavioral, dietary supplement and drug.

Who Took Part

Enrollment: 63 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: BMI ≥30 kg/m2 or ≥27kg/m2 with at least one weight-related medical condition. Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight. Have an established primary care provider.

The full record lists 3 inclusion and 44 exclusion criteria; among the exclusions: any single serum transaminase level (i.e., alt, ast, alk phos) ≥3x the upper limit of normal (uln); serum lipase and/or amylase levels ≥2x uln; uncontrolled thyroid disease, defined as abnormal tsh with abnormal ft4.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

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

It started in 2025-11-05 with completion listed for 2028-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in number of kilograms of lean mass by dual-energy x-ray absorptiometry (time frame: 52 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide and Bimagrumab in 63 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page and the Bimagrumab compound page, all human trials.

Our Notes on the Compounds

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

Bimagrumab: A monoclonal antibody that blocks activin type II receptors, studied by Lilly (via Versanis) to cut fat while keeping muscle during GLP-1 weight loss.

Related Pages

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.