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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of treatment adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
Drug: BGM0504 Administered SC
干预措施: Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week. (Drug)
Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.
Drug: BGM0504 Administered SC
干预措施: Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week. (Drug)
Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.
Drug: Placebo Administered SC
干预措施: Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week. (Drug)
结局指标
主要结局
Number of treatment adverse events
时间窗: 10 weeks
The relationship of each adverse event tothe investigational product was assessed by the investigator
次要结局
- Pharmacokinetic endpoint: Concentration of BGM0504 in plasma(10 weeks)
- Change in fasting weight at week 10(10 weeks)