Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Non-diabetic Overweight or Obese
In brief
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.
Key facts
- Study ID
- NCT07166081
- Run by
- BrightGene Bio-Medical Technology Co., Ltd.
- People needed
- 80
- Starts
- 2025-08-11
- Expected to finish
- 2026-05-13
- Last updated by the study team
- 2025-09-19
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Body mass index (BMI) meeting one of the following requirements:
- Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); OR
- 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.
You may not qualify if…
- 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.
Where it is running
- Pharmaron CPC, Inc — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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