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Clinical Trials in the USA / NCT07166081
Recruiting Phase 1

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

NCT07166081 · tracked via the Priya Life Science USA tracker
Sponsor
BrightGene Bio-Medical Technology Co., Ltd.
Phase
Phase 1
Started
2025-08-11
Last updated
2025-09-19

Condition(s) studied

Non-diabetic Overweight or Obese

Investigational drug(s) / intervention(s)

BGM0504BGM0504BGM0504PlaceboBGM0504

BGM0504: Administered orally

BGM0504: Administered orally

BGM0504: Administered orally

Placebo: Administered orally

BGM0504: Administered orally

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Pharmaron CPC, Inc Baltimore Maryland Recruiting

More BrightGene Bio-Medical Technology Co., Ltd. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07166081 on ClinicalTrials.gov ↗ ← All trials in the USA