Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia

Summary

The purpose of AROAPOC3-2001 is to evaluate the efficacy and safety of ARO-APOC3 in participants with severe hypertriglyceridemia. Participants will receive 2 subcutaneous injections of ARO-APOC3.

Timeline

Start

2021-05-31

Primary completion

2023-03-09

Completion

2023-08-31

Outcome

Met primary endpoint

paper Plozasiran induced significant dose-dependent placebo-adjusted least squares (LS)-mean reductions in triglyceride levels (primary end point) of -57% (95% CI, -71.9% to -42.1%; P < .001) PMID 38583092 ↗

registry analysis (superiority test); Placebo, Day 1 and Week 12 vs ARO-APOC3 50 mg; p < 0.0001; Difference -57.0 (95% CI -71.9 to -42.1) NCT04720534 ↗

release “Select SHASTA-2 Results Treatment with plozasiran led to dose-dependent placebo-adjusted reductions in triglycerides (primary endpoint) of -49%” arrowheadpharma.com ↗

Publications

• Gaudet D, Pall D, Watts GF, Nicholls SJ, Rosenson RS, Modesto K, San Martin J, Hellawell J, Ballantyne CM. Plozasiran (ARO-APOC3) for Severe Hypertriglyceridemia: The SHASTA-2 Randomized Clinical Trial. JAMA Cardiol. 2024 Jul 1;9(7):620-630. doi: 10.1001/jamacardio.2024.0959.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Plozasiran	Small interfering RNA (siRNA)	10 mg	Subcutaneous
Subject	Plozasiran	Small interfering RNA (siRNA)	25 mg	Subcutaneous
Subject	Plozasiran	Small interfering RNA (siRNA)	50 mg	Subcutaneous

Indications

No indication recorded.