A 12-Week Extension Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 11
- 主要终点
- The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This extension study will assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and non-diabetic subjects with overweight and obesity and non-alcoholic fatty liver disease (NAFLD).
详细描述
This extension study will enroll subjects who have completed 12 weeks of treatment in Study ALT-801-105. It is designed to allow for an additional 12 weeks of treatment in order to assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and non-diabetic subjects with overweight and obesity and non-alcoholic fatty liver disease (NAFLD).
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
- •Written informed consent to participate in this extension study, signed prior to the performance of any study procedures
- •Receipt of 12 weeks of investigational product with completion of the procedures in Study ALT-801-105
- •Women who are not pregnant or breastfeeding
排除标准
- •Meets any of the exclusion criteria in Study ALT-801-105 at the time of study entry
- •Development of any of the following conditions at any time during Study ALT-801-105:
- •Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105
- •History of pancreatitis or hypersensitivity reaction to GLP-1 analogues
研究组 & 干预措施
ALT-801 Dose Level 1
Administered once a week for 12 weeks
干预措施: ALT-801 (Drug)
ALT-801 Dose Level 2
Administered once a week for 12 weeks
干预措施: ALT-801 (Drug)
ALT-801 Dose Level 3
Administered once a week for 12 weeks
干预措施: ALT-801 (Drug)
Placebo
Administered once a week for 12 weeks
干预措施: Placebo (Other)
结局指标
主要结局
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to Day 110
Number of participants with one or more TEAEs
次要结局
- Change from baseline in body weight(Baseline to Day 85)
- Change from baseline in liver fat fraction by MRI-PDFF(Baseline to Day 85)
- Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)(Baseline to Day 85)
- Change from baseline in hemoglobin A1c(Baseline to Day 85)
- Change from baseline in fibrosis markers (Pro-C3)(Baseline to Day 85)