NCT07009860进行中（未招募）2 期
RESTORE TRIAL: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 121
- 试验地点
- 80
- 主要终点
- Relative (%) change in liver stiffness by VCTE compared to baseline at Week 24
研究概览
简要总结
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD.
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
- •Male or female ages 18 to 75 years, inclusive
- •Overweight or obesity, defined as BMI ≥ 25 kg/m2
- •History of alcohol misuse for the prior 3 years, with an alcohol intake ≥ 50 grams per day for males and ≥ 40 grams per day for females on average in the past year
- •Evidence of recent alcohol use, defined as PEth level ≥ 35 ng/mL at screening
- •Liver stiffness of 10.0-24.9 kPa by VCTE, inclusive
排除标准
- •Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
- •History of hospitalization for alcohol withdrawal within the past year
- •History of seizures related to alcohol within the past year
- •History and/or current diagnosis of schizophrenia, bipolar disorder, psychotic disorder, or another severe psychiatric disorder, unless documented as well-controlled by the Investigator for at least 6 months prior to screening and cleared by the Medical Monitor
- •Attempted suicide and/or serious suicidal intention or plan in the past 10 years
研究组 & 干预措施
Pemvidutide 2.4 mg
Active Comparator
干预措施: Pemvidutide (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Relative (%) change in liver stiffness by VCTE compared to baseline at Week 24
时间窗: Week 24
Relative (%) reduction in liver stiffness by VCTE compared to baseline
时间窗: Week 48 and 24
次要结局
- Relative (%) change in liver stiffness by VCTE compared to baseline at Week 48(Week 24 and 48)
- Absolute change in the Enhanced Liver Fibrosis (ELF) score at Weeks 24 and 48 compared to baseline(Week 24 and 48)
- Absolute reduction in liver stiffness by vibration controlled transient elastography (VCTE)(Week 48 and 24)
- Absolute reduction in the Enhanced Liver Fibrosis (ELF) compared to baseline(Week 48 and 24)
研究者
研究点 (80)
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