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A Study of BGM0504 in Participants With Obesity

Plain-language guide to NCT06911203: phase 2 randomized trial of Tirzepatide, 96 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06911203
Phase
phase 2
Status
completed
Start
2025-04-09
Completion (planned or actual)
2026-01-14
Participants
96 (actual)
Design
randomized, open label (everyone knows who gets what), 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.

It had two arms (groups): BGM0504 (experimental) and Tirzepatide (active comparator).

Participants will receive BGM0504 subcutaneously(SC).

Paritcipants will receive tirzepatide SC.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 96 actual participants took part.

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: ● Able and willing to provide a written informed consent. Male or female subjects, 18-65 years of age at the time of signing informed consent. At screening visit, 35.0 ﹤BMI﹤ 45.0 kg/m2;.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: ●History of chronic or acute pancreatitis; history of severe drug allergy or specific allergic disease or severe allergies; family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2(men-2).

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.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Being open-label, the Tirzepatide study did not mask who received what.

It started in 2025-04-09 with completion listed for 2026-01-14.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Body Weight (time frame: Week 0, Week 26).

It also tracked 5 secondary outcomes, for example Change From Baseline in BMI, Change From Baseline in Waist Circumference, Change from Baseline in Systolic Blood Pressure (SBP), Change from Baseline in Diastolic Blood Pressure (DBP) and Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 96 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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

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.

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.