A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-4082 in Healthy Overweight/Obese Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Number of Participants Who Experience an Adverse Event (AE)
研究概览
简要总结
Researchers are looking for new weight loss medicines for people with higher body weight. The study medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a study medicine to people with a health condition, researchers first do studies to find a safe dose level (amount) of the study medicine that can be used in future studies.
The goals of this study are to learn about:
- The safety of MK-4082 and if people tolerate it
- What happens to different MK-4082 dose levels in a person's body over time
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Is in good health
- •Has body mass index (BMI) between 25 and 40 kg/m^2, inclusive. Participants must weigh at least 60 kg
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •has a history of previous surgical treatment for obesity (bariatric surgery, gastric banding, etc.) or any other gastrointestinal (GI) surgery that may induce malabsorption, history of bowel resection >20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss (including LAP-BAND®), as well as clinically significant GI disorders (eg, peptic ulcers, severe gastroesophageal reflux disease)
- •has an individual or family history of medullary thyroid carcinoma or multiple endocrine neoplasia 2
研究组 & 干预措施
Panel E: Dose Escalation to Dosage 5
Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 5.
干预措施: Placebo (Drug)
Panel E: Dose Escalation to Dosage 5
Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 5.
干预措施: MK-4082 (Drug)
Panel A: Dose Escalation to Dosage 1
Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 1.
干预措施: Placebo (Drug)
Panel B: Dose Escalation to Dosage 2
Participants receive escalating doses of oral MK-4082 QD or a dose-matched placebo to reach maintenance dose 2.
干预措施: Placebo (Drug)
Panel C: Dose Escalation to Dosage 3
Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 3.
干预措施: Placebo (Drug)
Panel D: Dose Escalation to Dosage 4
Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 4.
干预措施: Placebo (Drug)
Panel B: Dose Escalation to Dosage 2
Participants receive escalating doses of oral MK-4082 QD or a dose-matched placebo to reach maintenance dose 2.
干预措施: MK-4082 (Drug)
Panel C: Dose Escalation to Dosage 3
Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 3.
干预措施: MK-4082 (Drug)
Panel D: Dose Escalation to Dosage 4
Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 4.
干预措施: MK-4082 (Drug)
Panel A: Dose Escalation to Dosage 1
Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 1.
干预措施: MK-4082 (Drug)
结局指标
主要结局
Number of Participants Who Experience an Adverse Event (AE)
时间窗: Up to approximately 98 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. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
时间窗: Up to approximately 84 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. The number of participants who discontinue study treatment due to an AE will be reported.
次要结局
- Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-4082(At designated timepoints (up to 24 hours postdose))
- Time to Maximum Plasma Concentration (Tmax) of MK-4082(Predose and at designated timepoints up to 84 Days postdose)
- Maximum Plasma Concentration (Cmax) of MK-4082(Predose and at designated timepoints up to 84 Days postdose)
- Plasma Concentration at 24 Hours (C24) of MK-4082(At designated timepoints up to 24 hours postdose)
- Area Under the Curve from Time 0 to Infinity (AUC0-Inf) of MK-4082(Predose and at designated timepoints up to 84 Days postdose)
- Area Under the Curve from Time 0 to Last (AUC0-Last) of MK-4082(Predose and at designated timepoints up to 84 Days postdose)
- Apparent Clearance (CL/F) of MK-4082(Predose and at designated timepoints up to 84 Days postdose)
- Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4082(Predose and at designated timepoints up to 84 Days postdose)
- Apparent Terminal Half-life (t1/2) of MK-4082(Predose and at designated timepoints up to 84 Days postdose)
- Change from Baseline in Body Weight(Baseline and up to approximately 84 Days)
- Change from Baseline in Body Mass Index (BMI)(Baseline and up to approximately 84 Days)