NCT07199309招募中2 期
Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of MAR001 on Postprandial Lipids in Patients With Elevated Triglycerides and Remnant Cholesterol
Marea Therapeutics1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline in TG area under the curve after a mixed meal
研究概览
简要总结
The primary objective of the study is to determine the effect of MAR001 as compared to placebo on levels of the triglycerides (TG) in the postprandial state in adults with elevated TG.
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 75 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 and all study assessments
- •Two fasting TG collected at two separate, consecutive visits at least 7 days apart during the Screening period
- •HbA1c ≥ 5.7% and ≤ 8.5%
- •Stable diet for a minimum of 3 months prior to screening and with no plans to change diet through duration of study
- •Stable drug regimen (appropriate if relevant) prior to screening visit and no planned changes during screening or trial participation
排除标准
- •Acute or chronic liver disease
- •Diabetes medications (other than metformin)
- •History of type 1 diabetes mellitus or history of diabetic ketoacidosis
- •Newly diagnosed T2DM
- •Participants with known active hepatitis A, B, or C
- •Participants who are known to have uncontrolled human immunodeficiency virus (HIV) infection
- •Uncontrolled hypothyroidism
- •Any condition that prevents the participant from complying with study procedures
研究组 & 干预措施
MAR001 Dose
Experimental
Subcutaneous Injection
干预措施: MAR001 (Drug)
Matching Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in TG area under the curve after a mixed meal
时间窗: 12 weeks
Change from baseline in peak plasma TG concentration after a mixed meal
时间窗: 12 weeks
次要结局
- Change from baseline in RC area under the curve after a mixed meal(12 weeks)
- Change from baseline in peak plasma RC concentration after a mixed meal(12 weeks)
研究者
研究点 (1)
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