Actively Recruiting
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2025-09-19
80
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 63 30.0 kg/m2 and 63 40.0 kg/m2 (obese); OR
- Body mass index (BMI) between 63 27.0 kg/m2 and < 30.0 kg/m2 (overweight) with at least one of the following: symptoms of prediabetes, grade 1 hypertension, simple fatty liver, or dyslipidemia
- Stable body weight with less than 5% self-reported change during the previous 12 weeks before screening
- Capable of understanding and willing to provide written informed consent
- Willing and able to comply with study schedule, requirements, and restrictions
You will not qualify if you...
- Allergic predisposition to 3 or more foods or drugs
- Allergy to glucagon-like peptide-1 (GLP-1) receptor agonists or severe allergic diseases such as asthma, urticaria, or eczematous dermatitis
- Use of GLP-1 receptor agonists or similar drugs within 12 weeks before screening
- Use of drugs impacting body weight within 12 weeks before screening
- Known type I or II diabetes
- History of acute or chronic pancreatitis or pancreatic injury
- History of drug abuse or alcoholism at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pharmaron CPC, Inc
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
M
MB ChB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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