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Olezarsen
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
Ensayo de IONIS PHARMACEUTICALS INC en Hypertriglyceridemia · Atherosclerotic Cardiovascular Disease · Severe Hypertriglyceridemia (del registro, en inglés).
Más ensayos de: Hipertrigliceridemia · Hipertrigliceridemia grave.
Lo que ha anunciado la empresa
La empresa anunció que alcanzó su objetivo principal…dL in CORE and CORE2, respectively. Participants were randomized to receive 50 mg or 80 mg of olezarsen or placebo every four weeks via subcutaneous injection for 12 months. The CORE and CORE2 studies met the primary endpoint, with both 50 mg and 80 mg monthly TRYNGOLZA doses. TRYNGOLZA demonstrated a statistically significant reduction in fasting triglycerides of 49%-63% (50 mg) and 55%-72% (80 mg) compared to placebo at…
En un 8-K del 24 jun 2026, en una frase que nombra «Olezarsen». El documento en la SEC.
La empresa anunció que alcanzó su objetivo principal…Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen in people with severe hypertriglyceridemia (sHTG). The studies met the primary endpoint, with olezarsen achieving a highly statistically significant placebo-adjusted mean reduction in fasting triglyceride (TG) levels of up to 72% at six months. The reductions were sustained through 12 months…
En un 8-K del 10 nov 2025, en una frase que nombra «Olezarsen». El documento en la SEC.
La empresa anunció que alcanzó su objetivo principal…elevated cardiovascular risk were recently published in The New England Journal of Medicine (NEJM) and presented during a hot line session at the European Society of Cardiology (ESC) Congress. Olezarsen met the primary endpoint, demonstrating a statistically significant reduction in fasting triglyceride levels at six months, and all key secondary endpoints. Olezarsen demonstrated a favorable safety and tolerability profile,…
En un 8-K del 2 sep 2025, en una frase que nombra «Olezarsen». El documento en la SEC.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 154
- Centros
- 24
- Fin del objetivo primario
- mar 2023
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en may 2022.
Qué mide
Percent Change From Baseline in Fasting TG at Month 6 (del registro, en inglés) (inicio y mes 6)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of the study was to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the proportion of participants who achieve different thresholds in fasting TG. Other objectives were to evaluate the effect of olezarsen on percent change in fasting apolipoprotein C-III (apoC-III), very low-density lipoprotein cholesterol (VLDL-C), remnant cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), HDL-C, total cholesterol (TC), apolipoprotein B (apoB), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein A-1 (apoA-1).
Más ensayos de IONS
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| zilganersen | Fase 3 | En marcha, sin reclutar | ago 2025 (real) |
| ION363 | Fase 3 | En marcha, sin reclutar | jun 2026 (real) |
| Donidalorsen | Fase 3 | En marcha, sin reclutar | dic 2026 (prevista) |
| Olezarsen | Fase 3 | En marcha, sin reclutar | mar 2027 (prevista) |
| ION717 | Fase 1/2 | En marcha, sin reclutar | abr 2027 (prevista) |
| Olezarsen | Fase 3 | En marcha, sin reclutar | jun 2027 (prevista) |
Todos los de IONS, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05355402), actualizada en abr 2026.