Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
Purpose
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.
Condition
- Hypertriglyceridemia
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental MAR001 Dose 1 (Part A) |
Subcutaneous injection |
|
|
Experimental MAR001 Dose 2 (Part A) |
Subcutaneous Injection |
|
|
Experimental MAR001 Dose 3 (Part A) |
Subcutaneous Injection |
|
|
Experimental MAR001 Dose 4 (Part B) |
Subcutaneous Injection |
|
Recruiting Locations
Boca Raton, Florida 33434
Port Saint Lucie, Florida 34952
Peachtree Corners, Georgia 30092
Springfield, Illinois 62702
St Louis, Missouri 63110
Little River, South Carolina 29566
Memphis, Tennessee 38119
More Details
- Status
- Recruiting
- Sponsor
- Marea Therapeutics
Detailed Description
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.