Arrowhead Pharmaceuticals has reported top line results from the global Phase III SHASTA-3 and SHASTA-4 clinical trials investigating plozasiran in severe hypertriglyceridaemia (sHTG) patients.
The placebo-controlled, double-blind studies met their primary goal, showing a reduction in triglyceride levels compared to placebo.
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They also met all prespecified secondary endpoints, including a statistically significant decrease in acute pancreatitis events.
Participants in SHASTA-3 and SHASTA-4 received 25 mg of plozasiran via subcutaneous injection every three months.
After 12 months, the trials recorded median triglyceride reductions of 79% and 81% respectively, while the placebo group saw reductions of around 27%.
A pre-planned pooled analysis from both studies found a statistically significant reduction in the rate of acute pancreatitis among those treated with plozasiran, with p values of less than 0.0221 for event rates and less than 0.0077 for total incidence rates.
In the broader study population, patients with triglyceride levels exceeding 500mg/dL, plozasiran treatment was associated with a 78% reduction in cumulative acute pancreatitis events compared to placebo.
Among the subset with triglycerides over 880mg/dL and a previous history of acute pancreatitis, SHASTA-3 and SHASTA-4 identified a 100% reduction in events for those receiving plozasiran.
The safety and tolerability profile of plozasiran in the studies was reported as consistent with previous research. The observed treatment-emergent adverse events aligned with earlier findings.
No new safety issues were detected, and the studies found no statistically significant differences between plozasiran and placebo in mean liver fat content or adverse changes in liver enzymes.
There were also no cases of hypersensitivity or thrombocytopenia.
Arrowhead chief medical officer and R&D head James Hamilton said: “These findings highlight the potential of plozasiran as a promising therapy for patients across the spectrum of sHTG.”
Arrowhead Pharmaceuticals plans to present detailed results from SHASTA-3 and SHASTA-4 at the European Society of Cardiology Congress on 30 August 2026.
The company intends to pursue marketing authorisation for plozasiran in multiple countries, beginning with a supplemental new drug application in the US before the end of this year.
