Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)
Summary
To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.
Timeline
- Start
- 2013-09
- Primary completion
- 2014-09
- Completion
- 2015-04
Outcome
Met primary endpoint
registry Placebo Q2W Without Concomitant Statin vs Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin; p <0.0001; LS Mean Difference -52.4 NCT01926782 ↗
registry Placebo Q2W Without Concomitant Statin vs Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin; p <0.0001; LS Mean Difference -55.2 NCT01926782 ↗
registry Placebo Q2W With Concomitant Statin vs Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin; p <0.0001; LS Mean Difference -58.7 NCT01926782 ↗
registry Placebo Q2W With Concomitant Statin vs Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin; p < 0.0001; LS Mean Difference -65 NCT01926782 ↗
Publications
- Roth EM, Kastelein JJP, Cannon CP, Farnier M, McKenney JM, DiCioccio AT, Brunet A, Manvelian G, Sasiela WJ, Baccara-Dinet MT, Zhao J, Robinson JG. Pharmacodynamic relationship between PCSK9, alirocumab, and LDL-C lowering in the ODYSSEY CHOICE I trial. J Clin Lipidol. 2020 Sep-Oct;14(5):707-719. doi: 10.1016/j.jacl.2020.07.009. Epub 2020 Jul 25.
- Muller-Wieland D, Rader DJ, Moriarty PM, Bergeron J, Langslet G, Ray KK, Manvelian G, Thompson D, Bujas-Bobanovic M, Roth EM. Efficacy and Safety of Alirocumab 300 mg Every 4 Weeks in Individuals With Type 2 Diabetes on Maximally Tolerated Statin. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5253-5262. doi: 10.1210/jc.2018-02703.
- Roth EM, Moriarty PM, Bergeron J, Langslet G, Manvelian G, Zhao J, Baccara-Dinet MT, Rader DJ; ODYSSEY CHOICE I investigators. A phase III randomized trial evaluating alirocumab 300 mg every 4 weeks as monotherapy or add-on to statin: ODYSSEY CHOICE I. Atherosclerosis. 2016 Nov;254:254-262. doi: 10.1016/j.atherosclerosis.2016.08.043. Epub 2016 Aug 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alirocumab | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Alirocumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Background | Atorvastatin | Small molecule | — | — |
| Background | Rosuvastatin | Small molecule | — | — |
| Background | Simvastatin | Small molecule | — | — |