A Study of BGM0504 in Overweight or Obese Participants

Phase 1

Recruiting

• Conditions: Overweight or Obese
• Interventions: Drug: Paracetamol; Drug: Metformin Hydrochloride; Drug: Warfarin; Drug: BGM0504

• Registration Number: NCT06920056
• Lead Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Brief Summary

The purpose of the study is to evaluate the influence of BGM0504 injection on gastric emptying and Pharmacokinetics of metformin and warfarin in overweight or obese participants

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-03-24
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-06-28
• Study Completion: 2025-06-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paracetamol + Metformin + Warfarin +BGM0504	Paracetamol	Participants receive Paracetamol on Day1 and Day70, Metformin on Day4 and Day73, Warfarin on Day7 and Day77. Participants receive maintenance dose 10 mg (from D42 to Day 77) with dose escalation starting from 2.5 mg(on Day 14 and Day 21), 5 mg(on Day 28 and Day 35) and then 10 mg BGM0504 administered subcutaneously (SC) once weekly (QW).
Paracetamol + Metformin + Warfarin +BGM0504	Metformin Hydrochloride	Participants receive Paracetamol on Day1 and Day70, Metformin on Day4 and Day73, Warfarin on Day7 and Day77. Participants receive maintenance dose 10 mg (from D42 to Day 77) with dose escalation starting from 2.5 mg(on Day 14 and Day 21), 5 mg(on Day 28 and Day 35) and then 10 mg BGM0504 administered subcutaneously (SC) once weekly (QW).
Paracetamol + Metformin + Warfarin +BGM0504	Warfarin	Participants receive Paracetamol on Day1 and Day70, Metformin on Day4 and Day73, Warfarin on Day7 and Day77. Participants receive maintenance dose 10 mg (from D42 to Day 77) with dose escalation starting from 2.5 mg(on Day 14 and Day 21), 5 mg(on Day 28 and Day 35) and then 10 mg BGM0504 administered subcutaneously (SC) once weekly (QW).
Paracetamol + Metformin + Warfarin +BGM0504	BGM0504	Participants receive Paracetamol on Day1 and Day70, Metformin on Day4 and Day73, Warfarin on Day7 and Day77. Participants receive maintenance dose 10 mg (from D42 to Day 77) with dose escalation starting from 2.5 mg(on Day 14 and Day 21), 5 mg(on Day 28 and Day 35) and then 10 mg BGM0504 administered subcutaneously (SC) once weekly (QW).

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Paracetamol	From Day1 to Day72	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Paracetamol
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Metformin	From Day4 to Day76	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Metformin
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin	From Day4 to Day76	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin	From Day7 to Day84	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Paracetamol	From Day1 to Day72	Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) of Paracetamol
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin	From Day7 to Day84	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin

Secondary Outcome Measures

Name	Time	Method
Area Under the Stable-State Concentration Versus Time Curve (AUC0-∞,ss ) of BGM0504	From Day14 to Day69	Area Under the Stable-State Concentration Versus Time Curve (AUC0-∞,ss ) of BGM0504
Time to Maximum Concentration (Tmax) of Metformin and Warfarin	From Day1 to Day84	Time to Maximum Concentration (Tmax) of Metformin and Warfarin
Terminal Half-life (t1/2) of Paracetamol	From Day1 to Day72	Terminal Half-life (t1/2) of Paracetamol

Trial Locations

Locations (1)

The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine); 🇨🇳 Kunming, Yunnan, China