A Study of BGM0504 in Overweight or Obese Participants

BrightGene Bio-Medical Technology Co., Ltd.

Status and phase: Enrolling; Phase 1

Conditions: Overweight or Obese

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06920056

BGM0504-DDI

Details and patient eligibility

About

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

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Paracetamol + Metformin + Warfarin +BGM0504

Experimental group

Description:

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).

Treatment:

Drug: BGM0504

Drug: Metformin Hydrochloride

Drug: Paracetamol

Drug: Warfarin