DelfaGLP-1 Atlas

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RecruitingPhase 1

Bioequivalence Study of BGM0504 Injection

A Single-Center, Single-Dose, Randomized, Open-Label, Single-Period, Parallel Bioequivalence Study of BGM0504 Injection in Overweight/Obese Participants

Asset

BGM0504

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

144

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≤28

Primary endpoints

•Peak Plasma Concentration (Cmax)•AUC0-t

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 IDNCT07382908
Org study IDBGM0504-BE

Timeline

Milestones

Study start2025-12-23actual
Study first posted2026-02-03actual
Last update posted2026-02-03actual
Primary completion2026-02-12estimated
Study completion2026-02-12estimated

Assets

Investigational agents

BGM0504

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age 18-55 years (inclusive).
•Male weight ≥50 kg, female weight ≥45 kg, and overweight (24.0 ≤ BMI < 28.0 kg/m²) or obese (BMI ≥ 28.0 kg/m²).
•From signing the ICF until 3 months after dosing, no pregnancy plan and willing to use effective contraception to avoid pregnancy or causing partner pregnancy, and no plan for sperm/egg donation.
•The participant fully understands the trial purpose, nature, methods, and potential adverse reactions, can complete the trial according to the protocol, has good living habits, can maintain good communication with the investigator, and voluntarily signs the ICF.

Exclusion criteria

•History of severe allergies or severe specific allergic diseases/history (asthma, urticaria, eczematous dermatitis, etc.) or allergic constitution (allergic to two or more foods or drugs), known or suspected allergy to any excipient of BGM0504 Injection.
•Previous diagnosis of type 1 or type 2 diabetes, or clinically significant abnormal HbA1c at screening.
•Family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 syndrome.
•History of acute/chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis.
•Past or screening findings of digestive system diseases that may increase participant risk.
•Positive for HBsAg, HCV antibody, syphilis antibody, or HIV antibody at screening.
•Participation in any drug or medical device clinical trial and receiving investigational product/device intervention within 3 months prior to screening.
•Consumption or plan to consume specific foods (including pitaya, mango, grapefruit, pomelo or their juices, high-purine foods like animal organs, seafood, chocolate) or beverages containing caffeine/alcohol within 48 hours before dosing; or unwilling to stop consuming these during the in-house period.
•Pregnant or breastfeeding women, or positive pregnancy test at screening.
•Any other condition considered by the investigator as unsuitable for participation or participant withdrawal due to personal reasons..

Endpoints (3)

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.

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Peak Plasma Concentration (Cmax)

Time frame:0 to 672 hours

Cmax

concentration, descriptive

Primary/protocol endpoint

Area under the plasma concentration versus time curve (AUC)0-t

Time frame:0 to 672 hours

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Monitor all the adverse event

Time frame:29 days

Treatment-emergent AEs (any)

descriptive, event

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.