NCT05896254已完成1 期
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of MAR001 in Patients With Metabolic Dysfunction
Marea Therapeutics2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年7月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Safety and tolerability of MAR001
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of multiple doses of MAR001in adult volunteers with metabolic dysfunction.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Willingness to provide informed consent and comply with the intervention
- •Women of childbearing potential and men agreeing to use an appropriate method of contraception for the duration of the study
- •Evidence of metabolic dysfunction at screening (triglyceride levels > 2.8 mmol/L)
排除标准
- •Any condition which in the opinion of the investigator prevents the participant from complying with study procedures or prevents the participant from completing the study or interferes with the interpretation of study results
- •Pregnant or breastfeeding mothers
- •Terminal illness with expected survival of less than 1 year
- •Note: additional inclusion/exclusion criteria may apply, per protocol
研究组 & 干预措施
MAR001
Experimental
Subcutaneous injection
干预措施: MAR001 (Drug)
Placebo
Placebo Comparator
Subcutaneous injection
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of MAR001
时间窗: 12 weeks
Incidence and frequency of treatment-emergent adverse events
次要结局
- Effect of MAR001 on triglyceride metabolism(12 weeks)
研究者
研究点 (2)
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