Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects
Recruiting · NCT07166081 · Interventional (participants receive a specific treatment) · Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
BGM0504Placebo
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 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.
Where it is running
1 location listed across 1 US state.
- Pharmaron CPC, Inc - Baltimore, Maryland, United States