Clinical trial NCT06920056: A Study of BGM0504 in Overweight or Obese Participants
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Overweight or Obese
Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Paracetamol
timeFrame: From Day1 to Day72
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Paracetamol
timeFrame: From Day1 to Day72
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Metformin
timeFrame: From Day4 to Day76
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin
timeFrame: From Day4 to Day76
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t) of Warfarin
timeFrame: From Day7 to Day84
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Warfarin
timeFrame: From Day7 to Day84
Secondary outcomes:
measure: Area Under the Stable-State Concentration Versus Time Curve (AUC0-∞,ss ) of BGM0504
timeFrame: From Day14 to Day69
measure: Time to Maximum Concentration (Tmax) of Metformin and Warfarin
timeFrame: From Day1 to Day84
measure: Terminal Half-life (t1/2) of Paracetamol
timeFrame: From Day1 to Day72
Other outcomes:
Locations:
city: Kunming
country: China
facility: The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
state: Yunnan
Study officials:
References: