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)
Number of treatment adverse events — 11 weeks The relationship of each adverse event tothe investigational product was assessed by the investigator
Trial sites (1)
Facility
City
Region
Status
Pharmaron CPC, Inc
Baltimore
Maryland
Recruiting
More BrightGene Bio-Medical Technology Co., Ltd. trials in the USA
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.
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