Study of Plozasiran (ARO-APOC3) in Adults With Mixed Dyslipidemia

Summary

Participants who have met all protocol eligibility criteria will be randomly assigned to treatment (ARO-APOC3 or placebo) in a double-blind fashion and will be evaluated for safety and efficacy over 48 weeks. Participants will be counseled to remain on a specified diet throughout the study, as recommended by the Investigator in accordance with local standards of care. After week 48, participants will be eligible and invited to consent and continue in an open-label extension study. All placebo participants who opt to continue will switch to active drug (ARO-APOC3) during the extension study.

Timeline

Start

2021-09-28

Primary completion

2023-02-10

Completion

2023-08-14

Outcome

Met primary endpoint

registry Placebo vs ARO-APOC3 10 mg Q12W; p <0.0001; LS Mean Difference -49.8 (95% CI -59.0 to -40.6) NCT04998201 ↗

release “Select MUIR Results By silencing Apolipoprotein C-III (APOC3), plozasiran significantly reduced triglycerides and atherogenic triglyceride rich lipoproteins and increased HDL” arrowheadpharma.com ↗

Publications

• Ballantyne CM, Vasas S, Azizad M, Clifton P, Rosenson RS, Chang T, Melquist S, Zhou R, Mushin M, Leeper NJ, Hellawell J, Gaudet D. Plozasiran, an RNA Interference Agent Targeting APOC3, for Mixed Hyperlipidemia. N Engl J Med. 2024 Sep 12;391(10):899-912. doi: 10.1056/NEJMoa2404143. Epub 2024 May 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ARO-APOC3	Small interfering RNA (siRNA)	10 mg	Subcutaneous
Subject	ARO-APOC3	Small interfering RNA (siRNA)	25 mg	Subcutaneous
Subject	ARO-APOC3	Small interfering RNA (siRNA)	50 mg	Subcutaneous

Indications