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

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

Study Overview

• Status: Completed
• Conditions: Overweight or Obese
• Intervention / Treatment: Drug: BGM0504; Drug: Paracetamol; Drug: Metformin Hydrochloride; Drug: Warfarin

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650100
      • The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paracetamol + Metformin + Warfarin +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).	Drug: BGM0504; Administered SC; Drug: Paracetamol; oral, postprandial; Drug: Metformin Hydrochloride; Oral , Fasting; Drug: Warfarin; Oral , Fasting

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Actual): July 25, 2025
• Study Completion (Actual): July 25, 2025

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Biguanides; Guanidines; Amidines; Coumarins; Benzopyrans; 4-Hydroxycoumarins; Acetaminophen; Metformin; Warfarin
• Other Study ID Numbers: BGM0504-DDI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No