A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK3102 in Obese Subjects and in Patients With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Number of Participants Withdrawing From Study Therapy Due to an AE
研究概览
简要总结
This study will test the safety and tolerability of omarigliptin. It is hypothesized that administration of once-weekly omarigliptin in obese but otherwise healthy participants, and in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated to permit continued clinical investigation.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •obese (body mass index [BMI] ≥30 kg/m² and ≤40 kg/m²) male participants and female participants of non-childbearing potential
- •has been diagnosed with T2D (Panel B)
- •is not actively participating in a weight loss program
排除标准
- •has a history of clinically-significant disease (other than T2D)
- •has a history of cancer
- •has estimated creatinine clearance ≤60 mL/min
- •is unable to refrain from or anticipates the use of any prescription or non-prescription medication
- •consumes excessive amounts of alcohol or caffeine
- •has participated in a previous omarigliptin study
研究组 & 干预措施
Healthy Placebo
Obese healthy participants receive once-weekly placebo by mouth for 4 weeks (Panel A).
干预措施: Placebo (Drug)
Healthy Omarigliptin
Obese healthy participants receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel A).
干预措施: Omarigliptin (Drug)
T2D Omarigliptin
Obese participants with T2D receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel B).
干预措施: Omarigliptin (Drug)
T2D Placebo
Obese participants with T2D receive once-weekly placebo by mouth for 4 weeks (Panel B).
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Withdrawing From Study Therapy Due to an AE
时间窗: Up to Day 22
Number of Participants Experiencing an Adverse Event (AE)
时间窗: Up to Day 36
次要结局
- Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15(168 hours post-dose on Day 15)
- Percent Inhibition of DPP-4 After Day 22(168 hours post dose on Day 22)
- WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration(Through 4 hours post dose on Day 21)
- WAA Total GLP-1 Concentration(Through 4 hours post dose on Day 21)
- Plasma Glucose Concentration(Through 4 hours post dose on Day 21)