Enrollment completed for phase III PALISADE clinical trial evaluating ARO-APOC3 for treatment of familial chylomicronemia syndrome. - Arrowhead Pharma
Arrowhead Pharmaceuticals Inc. announced that it has completed enrollment of its global Phase III clinical trial (PALISADE) evaluating ARO-APOC3 for the treatment of familial chylomicronemia syndrome.
The company anticipates that the primary portion of the study will be complete in the second quarter of 2024 with a data readout shortly thereafter and subsequent submissions for regulatory review and approval.
About the PALISADE Phase III Study : The AROAPOC3-3001 PALISADE study (NCT05089084) is a Phase III placebo controlled study to evaluate the efficacy and safety of ARO-APOC3 in adults with FCS. The primary endpoint of the study is percent change from baseline in fasting TG at Month 10. A total of 75 subjects distributed across 39 different sites in 18 countries were randomized to receive 25 mg ARO-APOC3, 50 mg ARO-APOC3, or matching placebo once every three months. Participants who complete the randomized period are eligible to continue in a 2-part extension period, where all participants will receive ARO-APOC3.
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