A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Tolerability, Pharmacodynamics and Pharmacokinetics of ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 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 is a Phase 1, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALT-801 and its effects on glucose control in overweight and obese subjects with type 2 diabetes mellitus (T2DM).
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 (BMI >/=28.0 kg/m2)
- •Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination of (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
- •Female subjects of childbearing potential who are not pregnant or breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control
排除标准
- •Type 1 diabetes mellitus (DM) and/or insulin-dependent T2DM, or uncontrolled T2DM defined as hemoglobin A1c (HbA1c) ≥ 9.5% or C-peptide ≤ 8 ng/mL
- •History of acute or chronic pancreatitis or hypersensitivity reaction to GLP-1 analogues
研究组 & 干预措施
ALT-801 1.2 mg
1.2 mg once weekly for 12 weeks
干预措施: ALT-801 (Drug)
ALT-801 1.8 mg
1.8 mg once weekly for 12 weeks
干预措施: ALT-801 (Drug)
ALT-801 2.4 mg
0.6 mg at Week 1, 1.2 mg at Week 2, 1.8 mg once weekly for 2 weeks (Weeks 3 and 4), and 2.4 mg once weekly for Weeks 5 through 12
干预措施: ALT-801 (Drug)
Placebo
placebo once weekly 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
Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin
时间窗: Baseline to Day 85
Changes from baseline in fasting serum glucose and insulin as measured by Homeostasis Model Assessment for Insulin Resistance 2 (HOMA-IR2)
时间窗: Baseline to Day 85
次要结局
- Change from baseline in hemoglobin A1c (HbA1c)(Baseline to Day 85)
- Change from baseline in fasting serum glucose(Baseline to Day 85)