A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease

Phase 3 Active not recruiting 16124 enrolled University of Oxford Novartis Pharmaceuticals · collab The TIMI Study Group · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

ORION-4 is a research study coordinated by the University of Oxford and co-sponsored by The University of Oxford and Novartis (Protocol: CTSU\_MDCO-PCS-17-01 (CKJX839B12301)). The study aims to find out if a new cholesterol-lowering injection (inclisiran) safely lowers the risk of heart attacks and strokes in people who have already had one of these conditions, or who have had an operation or procedure to treat blocked arteries.

Timeline

Start: 2018-10-30
Primary completion: 2026-10
Completion: 2049-12

Publications

Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Inclisiran	Small interfering RNA (siRNA)	300 mg	Subcutaneous

A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease

Summary

Timeline

Publications

Drugs

Indications