drugset / Trial / NCT05610280
A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.
Timeline
- Start
- 2022-11-21
- Primary completion
- 2024-08-08
- Completion
- 2025-06-09
Outcome
Met primary endpoint
paper -58.4 percentage points (95% confidence interval [CI], -65.1 to -51.7; P<0.001) in the olezarsen 50-mg group PMID 40888739 ↗
paper treatment with olezarsen resulted in significantly greater reduction in triglyceride levels at 6 months than placebo. PMID 40888739 ↗
Publications
- Marston NA, Bergmark BA, Prohaska TA, Moura FA, Zimerman A, Alexander VJ, Kang YM, Weinland J, Ran X, Murphy SA, Zhang S, Li D, Banach M, Stroes ESG, Kiss R, Gaudet D, Vrablik M, Goudev A, Bax JJ, Budoff MJ, Foldyna B, Lu MT, Tsimikas S, Giugliano RP, Sabatine MS. Effect of APOC3 Inhibition With Olezarsen on Coronary Atherosclerosis: Essence-TIMI 73b Imaging Study. Circulation. 2026 May 19;153(20):1539-1548. doi: 10.1161/CIRCULATIONAHA.126.080012. Epub 2026 Mar 30.
- Bergmark BA, Marston NA, Prohaska TA, Alexander VJ, Zimerman A, Moura FA, Kang YM, Weinland J, Murphy SA, Goodrich EL, Zhang S, Li D, Banach M, Stroes E, Lu MT, Tsimikas S, Giugliano RP, Sabatine MS; Essence-TIMI 73b Investigators. Targeting APOC3 with Olezarsen in Moderate Hypertriglyceridemia. N Engl J Med. 2025 Oct 2;393(13):1279-1291. doi: 10.1056/NEJMoa2507227. Epub 2025 Aug 30.
- Bergmark BA, Marston NA, Prohaska TA, Alexander VJ, Zimerman A, Moura FA, Kang YM, Murphy SA, Zhang S, Lu MT, Karwatowska-Prokopczuk E, Tsimikas S, Giugliano RP, Sabatine MS. Olezarsen in patients with hypertriglyceridemia at high cardiovascular risk: Rationale and design of the Essence-TIMI 73b trial. Am Heart J. 2025 Aug;286:116-124. doi: 10.1016/j.ahj.2025.02.022. Epub 2025 Mar 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olezarsen | Antisense oligonucleotide | 50 mg | Subcutaneous |
| Subject | Olezarsen | Antisense oligonucleotide | 80 mg | Subcutaneous |