A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of MK-2828 in Participants With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 21
- 主要终点
- Number of Participants Who Experience an Adverse Event (AE)
研究概览
简要总结
The purpose of this study is to learn about the safety and if people tolerate a study medicine called MK-2828. The study will also measure what happens to MK-2828 in the body of a person with type 2 diabetes (T2D) over time (pharmacokinetic or PK study), and how it affects the amount of high-sensitivity C-reactive protein (hsCRP) in a person's blood.
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
- 24 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •With the exception of type 2 diabetes mellitus (T2DM), is in generally good health
- •Has a history of T2DM for ≥1 year at the time of screening based on self-reporting
- •Has a baseline HbA1C level of ≤10% at the time of screening
- •Has a stable weight (based on self-reporting) defined as ≤5 kg gain or loss of body weight for at least 3 months before Visit 1/Screening
- •T2DM treated with lifestyle modification alone or with stable doses (no significant change for ≥3 months from Visit 1/Screening, based on self-reporting) of ≤ 3 oral anti-diabetic medications and anticipated not to require dose adjustments during the study duration
- •Body mass index (BMI) between 25 and 40 kg/m2, inclusive
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has known systemic hypersensitivity to the MK-2828 drug substance or other nucleotide-binding, leucine-rich, protein 3 inhibitor (NLRP3i) based therapy, its inactive ingredients, or the placebo
- •Has a history of congestive heart failure (New York Heart Association [NYHA] Class 3 or 4)
- •Has a history of myocardial infarction, uncontrolled arrhythmias, cardiac revascularization, unstable peripheral arterial disease and/or stroke within 6 months of screening
- •History of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e., systemic allergic reaction) to prescription or nonprescription drugs or food
- •Has type 1 diabetes mellitus or secondary types of diabetes
- •Has experienced complications of diabetes such as ketoacidosis, unstable diabetic retinopathy, or maculopathy
- •Has previous or planned (during the trial period) obesity treatment with surgery or a weight loss device
研究组 & 干预措施
MK-2828
Participants receive daily MK-2828 for 28 days.
干预措施: MK-2828 (Drug)
Placebo
Participants receive daily placebo for 28 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experience an Adverse Event (AE)
时间窗: Up to approximately 42 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Who Discontinue Study Treatment Due to an AE
时间窗: Up to approximately 28 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
次要结局
- Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 1 Dose(24 hours post-Day 1 dose)
- Plasma Concentration of MK-2828 at 24 Hours Postdose (C24) After Day 27 Dose(Predose on Day 28)
- Change from Baseline in Placebo Corrected High-Sensitivity C-Reactive Protein (hsCRP) Serum Concentration(Baseline and Predose Day 28)