NCT07321678进行中（未招募）2 期
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Mean change from baseline in HbA1c up to 13 weeks in the treatment group compared with the placebo group
研究概览
简要总结
This randomized, double-blind, placebo-controlled Phase II study is designed to evaluate the efficacy, safety, and tolerability of ASC30 oral tablets formulation in participants with Type 2 Diabetes Mellitus
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 Type 2 Diabetes (T2D)
- •Have HbA1c ≥7.0% to ≤10.5% as determined by the central laboratory at screening.
- •Stable body weight (less than 5% self-reported change within the previous 3 months).
- •Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening.
排除标准
- •Have any prior diagnosis of type 1 diabetes mellitus (T1DM), or rare forms of diabetes mellitus
- •Have had more than 1 episode of severe hypoglycemia
- •Have poorly controlled hypertension
- •Have acute or chronic hepatitis and pancreatitis
- •Have evidence of a significant active and uncontrolled medical condition
研究组 & 干预措施
ASC30 tablets Dose 1
Experimental
Participants will receive ASC30 tablets Dose 1 administered orally once daily.
干预措施: ASC30 tablets (Drug)
ASC30 tablets Dose 2
Experimental
Participants will receive ASC30 tablets Dose 2 administered orally once daily.
干预措施: ASC30 tablets (Drug)
ASC30 tablets Dose 3
Experimental
Participants will receive ASC30 tablets Dose 3 administered orally once daily.
干预措施: ASC30 tablets (Drug)
Placebo
Placebo Comparator
Participants will receive Placebo administered orally once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from baseline in HbA1c up to 13 weeks in the treatment group compared with the placebo group
时间窗: Baseline and end of Week 13
次要结局
- Mean change from baseline in fasting blood glucose up to 13 weeks in the treatment group compared with the placebo group(Baseline and end of Week 13)
- Mean change from baseline in body weight up to 13 weeks in the treatment group compared with placebo group(Baseline and end of Week 13)
研究者
研究点 (8)
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