A Randomized, Double-blind, Placebo-controlled First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MBX 4291 in Adult Participants With Obesity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 5
- 主要终点
- Number of participants with Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of single and multiple subcutaneous (SC) doses of MBX 4291 in adults with obesity.
详细描述
This is a Phase 1, double-blind, placebo-controlled first-in-human study to evaluate the single ascending doses (SAD) and multiple ascending doses (MAD) of MBX 4291 in participants with obesity, who are otherwise generally healthy. Approximately 124 patients aged 18 to 65 years old will be enrolled.
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
- Triple (Participant, Care Provider, 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
- •Age of >18 to ≤65 years at the time of signing the informed consent.
- •Has a BMI of ≥30 to <50 kg/m2 at screening and baseline.
- •Weight-stable, i.e., no more than ±5% change in body weight for at least 3 months prior to screening and between screening and baseline.
排除标准
- •History of, or currently active, significant illness or medical disorders that in the opinion of the investigator may preclude participants from participating in the study.
- •History of currently active pancreatitis, type I and type II diabetes.
- •Secondary causes of obesity, including but not limited to hypothalamic, monogenic, syndromic, or endocrine causes.
- •A personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
研究组 & 干预措施
MBX 4291 (Part A)
Participants will be administered single ascending doses of MBX 4291, or matching placebo.
干预措施: MBX 4291 (Drug)
Placebo
Participants will be administered single or multiple ascending doses of placebo.
干预措施: Placebo (Drug)
MBX 4291 (Part B)
Participants will be administered multiple ascending doses of MBX 4291, or matching placebo.
干预措施: MBX 4291 (Drug)
MBX 4291 (Part C)
Participants will be administered multiple ascending doses of MBX 4291, or matching placebo.
干预措施: MBX 4291 (Drug)
结局指标
主要结局
Number of participants with Treatment Emergent Adverse Events (TEAEs)
时间窗: The total duration of study participation for each participant including screening, treatment period, follow-up, and end of study visit will be up to 91 days in Part A, up to 99 days in Part B, and up to 148 days in Part C.
Number of participants with Treatment Emergent Adverse Events (TEAEs)
时间窗: The total duration of study participation for each participant including screening, treatment period, follow-up, and end of study visit will be up to 91 days in Part A and up to 99 days in Part B.
次要结局
未报告次要终点