A Study of BGM0504 in Overweight or Obese Participants

NCT06920056 | Completed Phase 1 FDA Drug

• 1 other identifier: BGM0504-DDI
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight or Obese

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• 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

  From Day1 to Day84

• Terminal Half-life (t1/2) of Paracetamol

  From Day1 to Day72

Study Arms (1)

Paracetamol + Metformin + Warfarin +BGM0504

EXPERIMENTAL

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: Paracetamol; Drug: Metformin Hydrochloride; Drug: Warfarin; Drug: BGM0504

Interventions

Paracetamol DRUG

oral, postprandial

Paracetamol + Metformin + Warfarin +BGM0504

Metformin Hydrochloride DRUG

Oral , Fasting

Paracetamol + Metformin + Warfarin +BGM0504

Warfarin DRUG

Oral , Fasting

Paracetamol + Metformin + Warfarin +BGM0504

BGM0504 DRUG

Administered SC

Paracetamol + Metformin + Warfarin +BGM0504

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)

Kunming, Yunnan, 650100, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Acetaminophen; Metformin; Warfarin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Biguanides; Guanidines; Amidines; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 9, 2025
• Study Start: March 24, 2025
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-02

Locations

CN (1)