Efficacy and safety of highly purified ethyl icosapentate soft capsules (MND-21) for the treatment of severe hypertriglyceridemia: A 12-week, multi-center, placebo-controlled, randomized, double-blind, phase III clinical trial in China.

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.