A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets and ASC30 Tablets A1 in Participants With Obesity or Overweight With Weight-Related Comorbidities
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Percent change in body weight from Baseline up to Week 13
研究概览
简要总结
This randomized, double-blind, placebo-controlled phase IIa study is designed to evaluate the efficacy, safety, and tolerability of ASC30 Tablets and ASC30 Tablets A1.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have provided informed consent before initiation of any study-specific procedures.
- •Male or female participants, non-smokers, between 18 and 75 years of age (both inclusive).
- •No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.
排除标准
- •Have evidence of any clinically significant active or chronic disease.
- •Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.
- •Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
- •Have a history of acute or chronic pancreatitis.
- •Participants with a known clinically significant gastric emptying abnormality.
- •Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
- •Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.
研究组 & 干预措施
Cohort 1
Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
干预措施: ASC30 tablets or ASC30 tablets A1 or placebo (Drug)
Cohort 2
Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
干预措施: ASC30 tablets or ASC30 tablets A1 or placebo (Drug)
Cohort 3
Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
干预措施: ASC30 tablets or ASC30 tablets A1 or placebo (Drug)
Cohort 4
Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
干预措施: ASC30 tablets or ASC30 tablets A1 or placebo (Drug)
Cohort 5
Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
干预措施: ASC30 tablets or ASC30 tablets A1 or placebo (Drug)
Cohort 6
Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
干预措施: ASC30 tablets or ASC30 tablets A1 or placebo (Drug)
Cohort 7
Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
干预措施: ASC30 tablets or ASC30 tablets A1 or placebo (Drug)
结局指标
主要结局
Percent change in body weight from Baseline up to Week 13
时间窗: Baseline and Week 13
次要结局
- Change in body weight (absolute) from Baseline up to Week 13(Baseline and Week 13)
- Change in waist circumference from Baseline up to Week 13(Baseline and Week 13)
- Change in body mass index from Baseline to Week 13(Baseline and Week 13)
- Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)(Baseline and Week 13)