MAR001 Cuts Triglycerides Dramatically in Phase 2b Trial

Overview

• The TYDAL‑TIMI 78 phase 2b results, published in the New England Journal of Medicine and presented at the American Heart Association, reported on Monday that MAR001 lowered fasting triglycerides by about 39% to 45% versus placebo at 12 weeks across three dose levels.
• The randomized trial enrolled 235 adults who received monthly subcutaneous doses of MAR001 at 300 mg, 450 mg or 900 mg or placebo at 48 centers in the United States, Canada, Australia and New Zealand.
• MAR001 showed a clear dose response with larger absolute benefits in people with very high baseline triglycerides, producing roughly 57%–72% reductions in those with levels ≥500 mg/dL and 51.7% of participants in the 900 mg group reaching triglycerides below 150 mg/dL at 12 weeks.
• Through 24 weeks the drug was generally well tolerated, with similar or lower overall adverse event rates than placebo, fewer serious adverse events in the MAR001 group, and no reported cases of pancreatitis or elevated liver enzymes in treated patients.
• MAR001 remains investigational and a dedicated follow‑up study (TYDAL‑TIMI 78 part B) in severe hypertriglyceridemia is already under way while additional trials are needed to show whether triglyceride lowering translates into reduced pancreatitis or cardiovascular events.