Study of ARO-ANG3 in Adults With Mixed Dyslipidemia
Summary
The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will initially receive 2 subcutaneous injections of ARO-ANG3 or placebo. Participants who complete the double-blind treatment period may opt to continue in an open-label extension during which they will receive up to 8 doses of ARO-ANG3.
Timeline
- Start
- 2021-06-28
- Primary completion
- 2022-08-30
- Completion
- 2024-09-25
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs ARO-ANG3 50 mg; p <.0001; Difference vs. Placebo at Week 24 -51.22 NCT04832971 ↗
registry analysis (superiority test); Placebo vs ARO-ANG3 100 mg; p <.0001; Difference vs Placebo at Week 24 -56.56 NCT04832971 ↗
registry analysis (superiority test); Placebo vs ARO-ANG3 200 mg; p <.0001; Difference vs. Placebo at Week 24 -63.11 NCT04832971 ↗
release “Select ARCHES-2 Results Zodasiran treatment was associated with dose-dependent placebo adjusted reductions in triglycerides, remnant cholesterol, LDL-C, ApoB, and Non-HDL-C across all dose levels” arrowheadpharma.com ↗
Publications
- Rosenson RS, Gaudet D, Hegele RA, Ballantyne CM, Nicholls SJ, Lucas KJ, San Martin J, Zhou R, Muhsin M, Chang T, Hellawell J, Watts GF; ARCHES-2 Trial Team. Zodasiran, an RNAi Therapeutic Targeting ANGPTL3, for Mixed Hyperlipidemia. N Engl J Med. 2024 Sep 12;391(10):913-925. doi: 10.1056/NEJMoa2404147. Epub 2024 May 29.
- Dimitriadis K, Theofilis P, Iliakis P, Pyrpyris N, Dri E, Sakalidis A, Soulaidopoulos S, Tsioufis P, Fragkoulis C, Chrysohoou C, Tsiachris D, Tsioufis K. Management of dyslipidemia in coronary artery disease: the present and the future. Coron Artery Dis. 2024 Sep 1;35(6):516-524. doi: 10.1097/MCA.0000000000001375. Epub 2024 Apr 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | zodasiran | Small interfering RNA (siRNA) | 50 mg | Subcutaneous |
| Subject | zodasiran | Small interfering RNA (siRNA) | 100 mg | Subcutaneous |
| Subject | zodasiran | Small interfering RNA (siRNA) | 200 mg | Subcutaneous |