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
Conditions
Non-diabetic Overweight or Obese
Locations
Pharmaron CPC, Inc
Baltimore, Maryland 21201
United States