Arrowhead Pharmaceuticals Initiates Phase 2b Study of Investigational ARO-APOC3 for Treatment of Severe Hypertriglyceridemia
AROAPOC3-2001 is a double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of ARO-APOC3 in adults with SHTG. Three dose levels of ARO-APOC3 (10 mg, 25 mg and 50 mg) will be evaluated against placebo in participants who have mean fasting triglycerides of greater than or equal to 500 mg/dL (5.65 mmol/L) at screening. A total of approximately 300 participants will be enrolled in the study. All dose cohorts will enroll in parallel with 100 participants per dose cohort randomly assigned in a 3:1 ratio to receive ARO-APOC3 or placebo. Each participant will receive subcutaneous injections on day 1 and week 12. The duration of the study is approximately 54 weeks from screening to the week 48 end-of-study examination. The primary objective of the study is to evaluate the safety and efficacy of ARO-APOC3 in adults with SHTG and to select a dosing regimen for later stage clinical studies in this patient population.
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