Press Release Details
Arrowhead Pharmaceuticals Initiates Phase 2b Study of ARO-APOC3 for Treatment of Mixed Dyslipidemia
AROAPOC3-2002 (NCT04998201) is a double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of ARO-APOC3 in adults with mixed dyslipidemia. Four dose cohorts of ARO-APOC3 will be evaluated against placebo in participants who had the following at screening: (i) elevated triglycerides (TG) greater than or equal to 150 mg/dL (1.69 mmol/L) but less than 499 mg/dL (5.61 mmol/L), and (ii) non-high-density lipoprotein cholesterol (non-HDL-C) greater than or equal to 100 mg/dL (2.59 mmol/L) or low-density lipoprotein cholesterol (LDL-C) greater than or equal to 70 mg/dL (1.8 mmol/L) at screening. A total of approximately 320 participants will be enrolled in the study. All dose cohorts will enroll in parallel with approximately 80 participants per dose cohort, randomly assigned in a 3:1 ratio to receive ARO-APOC3 or placebo. In three cohorts (10 mg, 25 mg, 50 mg), each participant will receive a subcutaneous injection on day 1 and week 12 for a total of 2 injections. In one additional 50 mg cohort, each participant will receive a subcutaneous injection on day 1 and week 24 for a total of 2 injections. 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 mixed dyslipidemia and to select a dose and dosing regimen for later stage clinical studies in this patient population.
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