drugset / Trial / NCT05079919
A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.
Timeline
- Start
- 2021-10-25
- Primary completion
- 2024-10-22
- Completion
- 2025-07-08
Outcome
Met primary endpoint
paper treatment with olezarsen led to a significantly greater reduction in the triglyceride level at 6 months PMID 41211918 ↗
release “The CORE and CORE2 studies met the primary endpoint” ionis.com ↗
Publications
- Marston NA, Bergmark BA, Alexander VJ, Prohaska TA, Kang YM, Moura FA, Zimerman A, Waldman E, Weinland J, Murphy SA, Goodrich EL, Zhang S, Xia S, Li D, Goldberg AC, Goudev A, Badimon L, Kiss RG, Vrablik M, Gaudet D, Moulin P, Stroes ESG, Banach M, Cohen H, Blom D, Charng MJ, Nordestgaard BG, Nicholls SJ, Tsimikas S, Giugliano RP, Sabatine MS; CORE-TIMI 72a and CORE2-TIMI 72b Investigators. Olezarsen for Managing Severe Hypertriglyceridemia and Pancreatitis Risk. N Engl J Med. 2026 Jan 29;394(5):429-441. doi: 10.1056/NEJMoa2512761. Epub 2025 Nov 8.
- Marston NA, Bergmark BA, Alexander VJ, Karwatowska-Prokopczuk E, Kang YM, Moura FA, Prohaska TA, Zimerman A, Zhang S, Murphy SA, Tsimikas S, Giugliano RP, Sabatine MS. Design and rationale of the CORE-TIMI 72a and CORE2-TIMI 72b trials of olezarsen in patients with severe hypertriglyceridemia. Am Heart J. 2025 Aug;286:125-135. doi: 10.1016/j.ahj.2025.03.003. Epub 2025 Mar 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olezarsen | Antisense oligonucleotide | 50 mg | Subcutaneous |
| Subject | Olezarsen | Antisense oligonucleotide | 80 mg | Subcutaneous |
Indications
No indication recorded.