NCT07166081招募中1 期
A Phase 1, Double-Blind, Randomized, Ascending-Dose, Placebo-Controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets Orally Administered in Non-diabetic Overweight or Obese Adult Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 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, 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.
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: 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.
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.
- •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
Cohort 1
Experimental
20 mg BGM0504 administered orally
干预措施: BGM0504 (Drug)
Cohort 2
Experimental
40 mg BGM0504 administered orally
干预措施: BGM0504 (Drug)
Cohort 3
Experimental
60 mg BGM0504 administered orally
干预措施: BGM0504 (Drug)
Placebo
Placebo Comparator
Placebo administered orally
干预措施: Placebo (Drug)
Cohort 4
Experimental
80mg BGM0504 administered orally
干预措施: BGM0504 (Drug)
结局指标
主要结局
Number of treatment adverse events
时间窗: 11 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(11 weeks)
- Change in fasting weight at week 11(11 weeks)
研究者
研究点 (1)
Loading locations...
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