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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
316
Primary Endpoint
Percent change from baseline at Week 12 in fasting TG compared to placebo
Time frame: 12 weeks
Secondary Endpoint
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
Time frame: 12 weeks
Secondary Endpoint
Percent change from baseline at Week 12 in fasting RC compared to placebo
Time frame: 12 weeks
Secondary Endpoint
Percent change from baseline at Week 16 in non-fasting TG compared to placebo
Time frame: 16 weeks
Secondary Endpoint
Part A only: Percent change from baseline at Week 12 in fasting TG compared to placebo in participants with baseline TG ≥300 mg/dL
Time frame: 12 weeks
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Park Ridge, Illinois, United States
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Springfield, Illinois, United States
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