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Completed

NCT Number: NCT06920056

A Study of BGM0504 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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Kunming, Yunnan, 650100, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paracetamol

Drug

oral, postprandial

Metformin Hydrochloride

Drug

Oral , Fasting

Warfarin

Drug

Oral , Fasting

BGM0504

Drug

Administered SC

Primary outcomes

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

    Time frame: From Day1 to Day72

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

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

    Time frame: From Day1 to Day72

    Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) of Paracetamol

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

    Time frame: From Day4 to Day76

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

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

    Time frame: From Day4 to Day76

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

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

    Time frame: From Day7 to Day84

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

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

    Time frame: From Day7 to Day84

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

Secondary outcomes

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

    Time frame: From Day14 to Day69

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

  2. Time to Maximum Concentration (Tmax) of Metformin and Warfarin

    Time frame: From Day1 to Day84

    Time to Maximum Concentration (Tmax) of Metformin and Warfarin

  3. Terminal Half-life (t1/2) of Paracetamol

    Time frame: From Day1 to Day72

    Terminal Half-life (t1/2) of Paracetamol

Sponsors and collaborators

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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