A Study of BGM0504 in Overweight or Obese Participants

Sponsor
BrightGene Bio-Medical Technology Co., Ltd.
Study ID
NCT06920056
Phase
PHASE1
Status
Completed

Conditions

  • Overweight or Obese

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Paracetamol — DRUG
    oral, postprandial
  • Metformin Hydrochloride — DRUG
    Oral , Fasting
  • Warfarin — DRUG
    Oral , Fasting
  • BGM0504 — DRUG
    Administered SC

Study Details

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

Key Dates

Start date
Mar 24, 2025
Status verified
Feb 2025
Primary completion
Jul 25, 2025
Completion
Jul 25, 2025

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-t)of Paracetamol [ Time Frame: From Day1 to Day72 ]

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