Non-diabetic Overweight or Obese
Conditions
Brief summary
This is a Phase 1, double-blind, parallel-arm ,placebo-controlled study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), safety and tolerability of BGM0504 following multiple subcutaneous (SC) administrations in non-diabetic overweight or obese adult subjects.
Interventions
DRUGExperimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
Drug: BGM0504 Administered SC
DRUGExperimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.
Drug: BGM0504 Administered SC
DRUGPlacebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.
Drug: Placebo Administered SC
Sponsors
BrightGene Bio-Medical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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: 1) One or more of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia; 2) Weight-bearing joint pain; 3) Obesity causing dyspnea or obstructive sleep apnea syndrome * Have a stable body weight (\<5% self-reported change during the previous 8 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. * Surgical treatment for obesity. * Known type I/II diabetes. * History of acute or chronic pancreatitis or pancreatic injury. * History of drug abuse or alcoholism at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment adverse events | 10 weeks | The relationship of each adverse event tothe investigational product was assessed by the investigator |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic endpoint: Concentration of BGM0504 in plasma | 10 weeks |
| Change in fasting weight at week 10 | 10 weeks |
Countries
United States
Outcome results
None listed