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NCT07166081PHASE1Recruiting

Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects

BrightGene Bio-Medical Technology Co., Ltd.

Start Date

8/11/2025

Completion Date

5/13/2026

Summary

This is a Phase 1, single-center, randomized, placebo-controlled, ascending dose study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM0504 following daily oral administrations in non-diabetic overweight or obese adult subjects.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * Body mass index (BMI) meeting one of the following requirements: 1. Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); OR 2. Between ≥ 27.0 kg/m2 and \< 30.0 kg/m2 (overweight) with at least 1 of the following: One or more symptoms of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia * Have a stable body weight (\<5% self-reported change during the previous 12 weeks) before screening * Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study. Exclusion Criteria: * Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to glucagon-like peptide-1 (GLP-1) receptor agonists or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis). * Have received GLP-1 receptor agonists or similar drugs containing the same target within 12 weeks before screening. * Have received drugs that have an impact on body weight within 12 weeks before screening. * Known type I/II diabetes. * History of acute or chronic pancreatitis or pancreatic injury. * History of drug abuse or alcoholism at screening.

Interventions

DRUG

BGM0504

DRUG

BGM0504

DRUG

BGM0504

DRUG

Placebo

DRUG

BGM0504

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Conditions

Non-diabetic Overweight or Obese

Locations

Pharmaron CPC, Inc

Baltimore, Maryland 21201

United States