A Phase 1, 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 13
- 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
The purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease (NAFLD).
详细描述
This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess the effects of ALT-801 the safety of ALT-801and effects on hepatic fat fraction, anthropometric parameters, lipid metabolism, inflammatory markers and fibrosis markers in diabetic and non-diabetic overweight and obese (BMI 28.0-45.0 kg/m2) subjects with 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 signed prior to the performance of any study procedures
- •Male or female volunteers, age 18 to 65 years, inclusive
- •Overweight to obese (greater than or equal to BMI 28.0
- •Magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥ 10%
- •If subject has Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (SGLT-2) therapy
排除标准
- •Women who are pregnant or breastfeeding
- •Type 1 DM and/or insulin-dependent T2DM, or uncontrolled T2DM defined as HbA1c ≥ 9.5%
- •History of pancreatitis or hypersensitivity reaction to GLP-1 analogues
研究组 & 干预措施
Placebo
Administered once a week for 12 weeks
干预措施: Placebo (Other)
ALT-801 Dose Level 3
Administered once a week for 12 weeks
干预措施: ALT-801 (Drug)
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)
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 1 or more TEAEs up to Day 110
次要结局
- Change from baseline in liver fat fraction by MRI-PDFF(Baseline and Day 85)
- Change from baseline in body weight(Baseline and Day 85)
- Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)(Baseline and Day 85)
- Change from baseline in hemoglobin A1c(Baseline and Day 85)
- Change from baseline in fibrosis markers (Pro-C3)(Baseline and Day 85)