Phase 2b Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of MAR001 in Patients With Elevated Triglycerides and Remnant Cholesterol (TYDAL-TIMI 78)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 316
- 试验地点
- 178
- 主要终点
- Primary Endpoint
研究概览
简要总结
The primary objective of the study is to evaluate the effect of MAR001 compared to placebo on levels of TG in adults with elevated TG and RC.
详细描述
MAR-103 is a randomized, double-blind, parallel-group, placebo-controlled study with two parts (Part A and Part B).
In both Part A and Part B, participants will be randomized at Day 1. The study will include a screening period (up to 8 weeks), a 24-week treatment period, and a 12-week safety follow-up period. The 12-week safety follow-up period will include 2 clinic visits at Week 28 and Week 36 (End of Study).
Part A: Approximately 216 participants with baseline TG between 150 to 880 mg/dL will be enrolled in Part A at a 3:1 ratio of MAR001 to placebo for dosing every 4 weeks (Q4W). Three doses of MAR001 will be administered.
Part B: Approximately 100 participants with baseline TG between 450 and 2000 mg/dL will be enrolled in Part B at a 1:1 ratio of MAR001 to placebo for dosing every 4 weeks (Q4W). The MAR001 dose will be within the range tested during Part A and will be selected based on emerging Part A data.
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
- •Elevated fasting TGs and RC
- •Elevated nonfasting TGs and RC
- •Part A only: Fasting LDL-C ≥ 50 mg/dL (≥ 1.29 mmol/L) and ≤ 130 mg/dL (≤ 3.36 mmol/L)
- •Willingness to provide informed consent and comply with the intervention and all study assessments
- •Stable diet for a minimum of 3 months prior to screening and with no plans to change during screening or trial participation
- •Stable drug regimen (if relevant) prior to screening visit and no planned changes after enrollment; Part B only: adjustment of lipid-lowering therapy during the diet/lifestyle run-in period is permitted
排除标准
- •Acute or chronic liver disease
- •Part A only: TG concentration ≥880mg/dl; Part B only: TG concentration ≥2000 mg/dL
- •History of type 1 diabetes mellitus or history of diabetic ketoacidosis
- •Newly diagnosed T2DM
- •Participants with known active hepatitis A, B, or C
- •Uncontrolled hypothyroidism
- •Part B only: recent history of active pancreatitis
- •Part B only: genetically confirmed Familial Chylomicronemia Syndrome (FCS) diagnosis due to biallelic loss of function mutations in LPL or GPIHBP1
- •Part B only: use of ANGPTL3 and ApoC-III inhibitors
- •Any condition that prevents the participant from complying with study procedures
研究组 & 干预措施
MAR001 Dose 4 (Part B)
Subcutaneous Injection
干预措施: MAR001 (Drug)
MAR001 Dose 2 (Part A)
Subcutaneous Injection
干预措施: MAR001 (Drug)
MAR001 Dose 1 (Part A)
Subcutaneous injection
干预措施: MAR001 (Drug)
MAR001 Dose 1 (Part A)
Subcutaneous injection
干预措施: Placebo (Drug)
MAR001 Dose 2 (Part A)
Subcutaneous Injection
干预措施: Placebo (Drug)
MAR001 Dose 3 (Part A)
Subcutaneous Injection
干预措施: MAR001 (Drug)
MAR001 Dose 3 (Part A)
Subcutaneous Injection
干预措施: Placebo (Drug)
MAR001 Dose 4 (Part B)
Subcutaneous Injection
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Endpoint
时间窗: 12 weeks
Percent change from baseline at Week 12 in fasting TG compared to placebo
次要结局
- Secondary Endpoint(16 weeks)
- Secondary Endpoint(12 weeks)