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.
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.
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.
Parallel
BGM0504
DrugAdministered orally
BGM0504
DrugAdministered orally
BGM0504
DrugAdministered orally
Placebo
DrugAdministered orally
BGM0504
DrugAdministered orally
Number of treatment adverse events
The relationship of each adverse event tothe investigational product was assessed by the investigator
Pharmacokinetic endpoint: Concentration of BGM0504 in plasma
Change in fasting weight at week 11
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