MAR001 in adults with high triglycerides and remnant cholesterol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, double-blind, placebo-controlled trial with two parts. Part A enrolls about 216 adults with moderate triglyceride elevations to receive MAR001 or placebo every 4 weeks in a 3:1 ratio for 24 weeks, followed by safety follow-up. Part B enrolls about 100 adults with higher triglycerides in a 1:1 MAR001 vs placebo design for the same dosing schedule. The study includes screening, 24 weeks of treatment, and a 12-week safety follow-up with visits at Weeks 28 and 36. Primary endpoints focus on changes in triglyceride and remnant cholesterol levels from baseline.

Why it matters

Who can join: the full rules

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

Where it's running

• Marea Site 302
  Boca Raton, Florida, United States Recruiting
• Marea Site 307
  Port Saint Lucie, Florida, United States Recruiting
• Marea Site 319
  Peachtree Corners, Georgia, United States Recruiting
• Marea Site 325
  Springfield, Illinois, United States Recruiting
• Marea Site 305
  St Louis, Missouri, United States Recruiting
• Marea Site 320
  Little River, South Carolina, United States Recruiting

+5 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Matty Hughes
• Email: TYDAL_info@mareatx.com
• Phone: 415-766-3610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ion775 for high triglyceride levels: safety, tolerability, and how well it works

  A drug called ION775 is being tested to see if it can safely lower fasting triglycerides in adults with hypertriglyceridemia or severe hypertriglyceridemia who are already on standard lipid medicines.

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• Russian registry for people with very high triglycerides

  This registry collects health and genetic information from people in Russia who have very high triglycerides (≥10 mmol/L) to see what their causes, care, and outcomes look like.

  Recruiting at 6 sites Russian Cardiology Research and Production Center · Astrakhan and 5 other locations · NCT07508930

• CTX310 for refractory high triglycerides or LDL cholesterol

  This trial will test whether a single IV dose of CTX310 is safe and tolerated in adults whose high triglycerides or LDL cholesterol have not responded to available treatments.

  Recruiting at 16 sites Phase 1 CRISPR Therapeutics · Hialeah, Florida and 16 other locations · NCT07491172

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  This will test whether spinning fatty (lipemic) blood samples very fast helps the lab get accurate anti-Xa measurements for adults on anti-Xa anticoagulant medications.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07200674

• MAR001 for adults with high triglycerides and remnant cholesterol

  This trial will try the drug MAR001 to lower post-meal triglycerides and remnant cholesterol in adults with elevated triglyceride levels.

  Recruiting Phase 2 Marea Therapeutics · Chula Vista, California · NCT07199309

• JMT202 injections for adults with high triglycerides

  This will test whether repeated subcutaneous injections of JMT202 are safe and well tolerated in Chinese adults with high triglyceride levels.

  Recruiting Phase 1/2 Shanghai JMT-Bio Inc. · Beijing, Beijing Municipality · NCT07140809

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.