Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Hypertriglyceridemia
In brief
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.
Key facts
- Study ID
- NCT07028749
- Run by
- Marea Therapeutics
- People needed
- 316
- Starts
- 2025-06-30
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Marea Site 329 — Mobile, Alabama, United States (enrolling)
- Marea Site 313 — Little Rock, Arkansas, United States (enrolling)
- Marea Site 306 — Hamden, Connecticut, United States (enrolling)
- Marea Site 302 — Boca Raton, Florida, United States (enrolling)
- Marea Site 307 — Port Saint Lucie, Florida, United States (enrolling)
- Marea Site 310 — Columbus, Georgia, United States (enrolling)
- Marea Site 319 — Peachtree Corners, Georgia, United States (enrolling)
- Marea Site 317 — Park Ridge, Illinois, United States (enrolling)
- Marea Site 325 — Springfield, Illinois, United States (enrolling)
- Marea Site 301 — Louisville, Kentucky, United States (enrolling)
- Marea Site 316 — Baltimore, Maryland, United States (enrolling)
- Marea Site 330 — Kansas City, Missouri, United States (enrolling)
- Marea Site 305 — St Louis, Missouri, United States (enrolling)
- Marea Site 304 — Great Neck, New York, United States (enrolling)
- Marea Site 318 — New Windsor, New York, United States (enrolling)
- Marea Site 303 — Greensboro, North Carolina, United States (enrolling)
- Marea Site 315 — Winston-Salem, North Carolina, United States (enrolling)
- Marea Site 314 — Greenville, South Carolina, United States (enrolling)
- Marea Site 320 — Little River, South Carolina, United States (enrolling)
- Marea Site 326 — Memphis, Tennessee, United States (enrolling)
- Marea Site 322 — Amarillo, Texas, United States (enrolling)
- Marea Site 308 — McKinney, Texas, United States (enrolling)
- Marea Site 312 — San Antonio, Texas, United States (enrolling)
- Marea Site 321 — Manassas, Virginia, United States (enrolling)
- Marea Site 328 — Anniston, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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