Status:
RECRUITING
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects
Lead Sponsor:
BrightGene Bio-Medical Technology Co., Ltd.
Conditions:
Non-diabetic Overweight or Obese
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 tolera...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 13 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07166081
Start Date
August 11 2025
End Date
May 13 2026
Last Update
September 19 2025
Active Locations (1)
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1
Pharmaron CPC, Inc
Baltimore, Maryland, United States, 21201