Clinical trial
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects
Recruiting now · Phase 1 · 1 countries · Registry ID NCT07166081
Recruiting nowPhase 1Interventional
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionNon-diabetic Overweight or Obese
Full registry criteria
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.
Treatments and study arms
BGM0504
Drug
Administered orally
BGM0504
Drug
Administered orally
BGM0504
Drug
Administered orally
Placebo
Drug
Administered orally
BGM0504
Drug
Administered orally
Primary outcomes
Number of treatment adverse events11 weeks
The relationship of each adverse event tothe investigational product was assessed by the investigator
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Pharmaron CPC, Inc🇺🇸 Baltimore, Maryland, United States