J Clin Lipidol. 2025 Dec 14:S1933-2874(25)00539-2. doi: 10.1016/j.jacl.2025.12.007. Online ahead of print.
ABSTRACT
BACKGROUND: Severe hypertriglyceridemia is a major risk factor for cardiovascular disease and acute pancreatitis, where effective and well-tolerated treatments remain limited. MND-21, a highly purified form of ethyl icosapentate with a smaller capsule diameter than currently available products, has not yet been approved for the treatment of severe hypertriglyceridemia, highlighting the need for additional clinical evidence.
OBJECTIVE: To evaluate the efficacy and safety of MND-21 for the treatment of severe hypertriglyceridemia.
METHODS: In this multicenter, 12-week, double-blind, parallel, placebo-controlled study, participants with severe hypertriglyceridemia (triglyceride [TG] levels between ≥5.65 mmol/L [500 mg/dL] and <22.60 mmol/L [2000 mg/dL]) undergoing lifestyle modification were randomized to receive MND-21 1800 mg/d, MND-21 3600 mg/d, or placebo. The primary endpoint was the percentage change in TG levels from the baseline. This trial was registered at ClinicalTrials.gov (NCT04239950) and ChinaDrugTrials.org (CTR20191474).
RESULTS: The mean percentage changes in TG levels from the baseline to the end of treatment were -8.11, -13.88, and -18.38% in the placebo, MND-21 1800 mg, and MND-21 3600 mg groups, respectively. The MND-21 3600 mg group exhibited a significantly greater reduction in TG levels compared with the placebo group (P = .049). Both MND-21 1800 mg/d and MND-21 3600 mg/d were well tolerated, and no substantial differences in safety profiles were observed between the placebo group and either MND-21 dosage.
CONCLUSION: The superiority of MND-21 3600 mg/d over the placebo was observed, and MND-21 was safe and well tolerated.
PMID:41500861 | DOI:10.1016/j.jacl.2025.12.007