drugset / Trial / NCT03060577
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated low-density lipoprotein cholesterol (LDL-C).
Timeline
- Start
- 2017-04-27
- Primary completion
- 2021-12-17
- Completion
- 2021-12-17
Publications
- Ray KK, Troquay RPT, Visseren FLJ, Leiter LA, Scott Wright R, Vikarunnessa S, Talloczy Z, Zang X, Maheux P, Lesogor A, Landmesser U. Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial. Lancet Diabetes Endocrinol. 2023 Feb;11(2):109-119. doi: 10.1016/S2213-8587(22)00353-9. Epub 2023 Jan 5.
- 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 |
|---|---|---|---|---|
| Comparator | Evolocumab | Monoclonal antibody | 140 mg | Subcutaneous |
| Subject | Inclisiran | Small interfering RNA (siRNA) | 300 mg | Subcutaneous |