DelfaGLP-1 Atlas

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RecruitingPhase 2

A Study of BGM0504 in Participants With Obesity

A Phase II, Randomized Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BGM0504 Compared to Tirzepatide in Adults Who Have Obesity

Assets

BGM0504 / Tirzepatide

Listed sites

1

Recruiting sites

1

Enrollment

90

estimated

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06911203
Org study IDBGM0504-II -WL-02

Timeline

Milestones

Study start2025-04-03actual
Study first posted2025-04-04actual
Last update posted2025-10-28actual
Primary completion2026-01-11estimated
Study completion2026-01-11estimated

Assets

Investigational agents

BGM0504Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•● 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;
–Diet and exercise control for at least 3 months before screening visit, and be of stable weight (± 5%) self-reported change within the last 3 months.

Exclusion criteria

•●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).
–History of malignant tumors [except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma].
–Suspected or confirmed history of alcohol or drug abuse;
–Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
–Donation or loss of 400 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial.
–Pregnant or lactating woman.
–Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
3
Cardiometabolic biomarkers
2
Patient-reported / QoL
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Week 0, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in BMI

Time frame:Week 18, Week 26

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Week 18, Week 26

Waist circumference, change

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Week 18, Week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from Baseline in Diastolic Blood Pressure (DBP)

Time frame:Week 18, Week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)

Time frame:Week 0, Week 26

IWQOL-Lite total

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.