NCT06714955
Completed
Phase 1
A Phase 1, Double-Blind, Parallel-arm, Placebo-Controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection Administered Subcutaneously in Non-diabetic Overweight or Obese Adult Subjects
ConditionsNon-diabetic Overweight or Obese
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Non-diabetic Overweight or Obese
- Sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of treatment adverse events
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
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: 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.
Outcomes
Primary Outcomes
Number of treatment adverse events
Time Frame: 10 weeks
The relationship of each adverse event tothe investigational product was assessed by the investigator
Secondary Outcomes
- Pharmacokinetic endpoint: Concentration of BGM0504 in plasma(10 weeks)
- Change in fasting weight at week 10(10 weeks)
Study Sites (1)
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