A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed Non-alcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 18
- 主要终点
- Change alanine transaminase (ALT) levels
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 2a clinical trial to evaluate the efficacy and safety of DA 1241 in subjects with presumed non-alcoholic steatohepatitis (NASH).
详细描述
Clinical trial DA1241_NASH_IIa is a multicenter, randomized, double-blind, placebo-controlled, parallel-arm, Phase 2a clinical trial to evaluate the efficacy and safety of DA-1241 in subjects with presumed NAFLD.
Part 1 of this clinical trial intends to explore the efficacy of DA-1241 in subjects with NASH after administration of oral DA-1241 at varying doses or identical placebo in 3 treatment groups for 16 weeks/112 days.
Part 2 intends to explore the efficacy of DA-1241 in subjects with NASH after administration of oral DA-1241 in combination with sitagliptin versus an identical placebo for 16 weeks/112 days.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1 Group 3.1
DA-1241 Placebo and Sitagliptin Placebo
In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio.
干预措施: DA-1241 Placebo (Drug)
Part 1 Group 1
DA-1241 Dose 1
In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio.
干预措施: DA-1241 (Drug)
Part 1 Group 1
DA-1241 Dose 1
In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio.
干预措施: DA-1241 Placebo (Drug)
Part 1 Group 3.1
DA-1241 Placebo and Sitagliptin Placebo
In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio.
干预措施: Sitagliptin Placebo (Drug)
Part 1 Group 1
DA-1241 Dose 1
In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio.
干预措施: Sitagliptin Placebo (Drug)
Part 1 Group 2
DA-1241 Dose 2
In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio.
干预措施: DA-1241 (Drug)
Part 1 Group 2
DA-1241 Dose 2
In Part 1: Participants will be randomized into 3 treatment groups and will be dosed with: DA-1241 or placebo in a 1:2:1 ratio.
干预措施: Sitagliptin Placebo (Drug)
Part 2 Group 3.2
DA-1241 Placebo and Sitagliptin Placebo
In Part 2: Participants will be randomized into 2 treatment groups and will be dosed with: DA-1241 in combination with sitagliptin (DA-1241/sitagliptin) or DA-1241/ sitagliptin placebo in a 2:1 ratio.
干预措施: DA-1241 Placebo (Drug)
Part 2 Group 3.2
DA-1241 Placebo and Sitagliptin Placebo
In Part 2: Participants will be randomized into 2 treatment groups and will be dosed with: DA-1241 in combination with sitagliptin (DA-1241/sitagliptin) or DA-1241/ sitagliptin placebo in a 2:1 ratio.
干预措施: Sitagliptin Placebo (Drug)
Part 2 Group 4
DA-1241 and Sitagliptin
In Part 2: Participants will be randomized into 2 treatment groups and will be dosed with: DA-1241 in combination with sitagliptin (DA-1241/sitagliptin) or DA-1241/ sitagliptin placebo in a 2:1 ratio.
干预措施: DA-1241 (Drug)
Part 2 Group 4
DA-1241 and Sitagliptin
In Part 2: Participants will be randomized into 2 treatment groups and will be dosed with: DA-1241 in combination with sitagliptin (DA-1241/sitagliptin) or DA-1241/ sitagliptin placebo in a 2:1 ratio.
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Change alanine transaminase (ALT) levels
时间窗: Baseline to Day 112
To explore the efficacy (change from baseline in alanine transaminase \[ALT\]) of DA-1241 in subjects at risk of NASH or subjects with non-alcoholic fatty liver disease (NAFLD) after administration of oral DA-1241 at varying doses of placebo and in combination with sitagliptin.
次要结局
- Adipo-IR(Baseline to Day 112)
- AST, GGT, ALP(Baseline to Day 112)
- Total cholesterol, LDL, HDL, triglyceride, and free fatty acids(Baseline to Day 112)
- CAP(Baseline to Day 112)
- ALT Normalization(Baseline to Day 112)
- Glucose(Baseline to Day 112)
- HOMA-IR(Baseline to Day 112)
- Fasting insulin(Baseline to Day 112)
- A1c(Baseline to Day 112)
- VCTE(Baseline to Day 112)
- FAST(Baseline to Day 112)
- Body weight(Baseline to Day 112)