Aug. 4, 2025 — Marea Therapeutics, Inc., a clinical-stage biotechnology company that develops next-generation medicines for cardioendocrine diseases, recently announced that the first patient has been enrolled in its Phase 2b TYDAL-TIMI 78 study evaluating MAR001 in adults with elevated levels of triglycerides (TG) and remnant cholesterol (RC) at increased risk of atherosclerotic cardiovascular disease (ASCVD). MAR001 is a monoclonal antibody delivered by subcutaneous injection that is designed to block the activity of ANGPTL4, a protein that is highly expressed in adipose tissue. MAR001 is being developed to address unmet risk in patients with ASCVD and persistently elevated levels of TG and RC.
The Phase 2b TYDAL-TIMI 78 study aims to enroll approximately 216 patients who will be randomized in a 3:1 ratio to receive MAR001 or placebo every four weeks for 24 weeks. Patients in the MAR001 arms will be randomized to receive 300mg, 450mg or 900mg. The primary endpoints will evaluate the percent change from baseline at week 12 in fasting TGs and fasting RC as compared with placebo. Safety and tolerability will be assessed, and secondary endpoints include changes in fasting very low-density lipoprotein cholesterol (VLDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C).
"Despite significant progress in managing cardiovascular risk, many patients continue to face elevated risk due to high levels of remnant cholesterol carried on triglyceride-rich lipoproteins. The TYDAL-TIMI 78 study offers an important opportunity to explore the therapeutic potential of MAR001, a genetically informed and promising approach to targeting ANGPTL4,” said Marc S. Sabatine, M.D., M.P.H., chairman of the thrombolysis in myocardial infarction (TIMI) study group and TYDAL study chair. “By addressing a major unmet need with a novel mechanism, this trial could pave the way for a new class of therapies to reduce residual risk in patients with cardiometabolic disease. We’re pleased to lead this important study and look forward to evaluating MAR001’s impact on meaningful lipid parameters and overall cardiovascular health.”
“The initiation of the TYDAL study marks an important milestone for Marea and for patients at risk of atherosclerotic cardiovascular disease,” said Josh Lehrer, M.D., chief executive officer of Marea. “MAR001 is a first-in-class, genetically validated investigational therapy with the potential to improve outcomes by reducing remnant cholesterol and triglycerides - two critical and under-addressed drivers of residual cardiovascular risk. We’re advancing MAR001 into a Phase 2b trial and aim to generate data that could shift the treatment paradigm in cardiometabolic disease. MAR001 may offer precision therapy for patients with elevated residual risk despite control of traditional factors. We expect topline TYDAL results in mid-2026 and are energized to move this innovative therapy closer to the patient.”
For more information go to www.mareatx.com
November 14, 2025 
