Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects
A Phase 1, Double-Blind, Randomized, Ascending-Dose, Placebo-Controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets Orally Administered in Non-diabetic Overweight or Obese Adult Subjects
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- BGM0504 (drug)
- BGM0504 (drug)
- BGM0504 (drug)
- Placebo (drug)
- BGM0504 (drug)
Sponsor: BrightGene Bio-Medical Technology Co., Ltd. · Participants: 80 · Started: Aug 11, 2025
Contact the study team
- MB ChB · Phone: 240-673-0900
Official record on ClinicalTrials.gov — NCT07166081
Locations in the U.S.
| Maryland | Pharmaron CPC, Inc, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.