DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06920056

CompletedPhase 1

A Study of BGM0504 in Overweight or Obese Participants

A Single Center, Open-label, Fixed Sequence Trial, Investigating the Influence of BGM0504 Injection on Gastric Emptying and Pharmacokinetics of Metformin and Warfarin in Overweight or Obese Participants

Asset

BGM0504

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

28

actual

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoints

•AUCof Paracetamol•Cmax of Paracetamol•AUC of Metformin

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 IDNCT06920056
Org study IDBGM0504-DDI

Timeline

Milestones

Study start2025-03-24actual
Study first posted2025-04-09actual
Primary completion2025-07-25actual
Study completion2025-07-25actual
Last update posted2025-09-09actual

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

√ Have a body mass index (BMI) of greater than or equal to (≥)28 kilogram per square meter (kg/m²) or ≥24 kg/m2 and less than (<) 28 kg/m².

√ Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff.

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 (9)

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

9 endpoints
Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Paracetamol

Time frame:From Day1 to Day72

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Paracetamol

Time frame:From Day1 to Day72

Cmax

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Metformin

Time frame:From Day4 to Day76

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin

Time frame:From Day4 to Day76

Cmax

concentration, descriptive

Primary/protocol endpoint/low confidence

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin

Time frame:From Day7 to Day84

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin

Time frame:From Day7 to Day84

Cmax

concentration, descriptive

Secondary/protocol endpoint

Area Under the Stable-State Concentration Versus Time Curve (AUC0-∞,ss ) of BGM0504

Time frame:From Day14 to Day69

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Time to Maximum Concentration (Tmax) of Metformin and Warfarin

Time frame:From Day1 to Day84

Tmax

concentration, descriptive

Secondary/protocol endpoint

Terminal Half-life (t1/2) of Paracetamol

Time frame:From Day1 to Day72

Half-life

descriptive

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.