Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
ID: NCT07028749
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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.
Read Full Scientific Objectives & Methods
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.
Subcutaneous Injection
Subcutaneous injection
Treatment Arms Description
Subcutaneous injection
Subcutaneous Injection
Subcutaneous Injection
Subcutaneous Injection
- 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
- 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
Primary Outcome Measures
- Primary Endpoint — Time Frame: 12 weeks
Percent change from baseline at Week 12 in fasting TG compared to placebo
View Secondary Outcome Measures (4)
- Secondary Endpoint — Time Frame: 12 weeks
Proportion of participants with Part A: baseline TG ≥150 mg/dL achieving TG \<150 mg/dL at Week 12 compared to placebo Part B: baseline TG ≥500 mg/dL achieving TG \<500 mg/dL at Week 12 compared to placebo
- Secondary Endpoint — Time Frame: 12 weeks
Percent change from baseline at Week 12 in fasting RC compared to placebo
- Secondary Endpoint — Time Frame: 16 weeks
Percent change from baseline at Week 16 in non-fasting TG compared to placebo
- Secondary Endpoint — Time Frame: 12 weeks
Part A only: Percent change from baseline at Week 12 in fasting TG compared to placebo in participants with baseline TG ≥300 mg/dL
This trial is recruiting at 55 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 55 Facilities & Contact Sites
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View Official Medical/Scientific Title
Phase 2b Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of MAR001 in Patients With Elevated Triglycerides and Remnant Cholesterol (TYDAL-TIMI 78)