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# Ionis Reports Positive Olezarsen Trial Data
- URL: https://www.fdaweb.com/ionis-reports-positive-olezarsen-trial-data/
- Published: 2025-05-19T12:00:00.000Z
- Updated: 2026-09-14T15:12:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159203

Ionis Pharmaceuticals is announcing “positive topline results” from the Essence study of olezarsen in people with moderate hypertriglyceridemia. “The trial met its primary endpoint with a statistically significant placebo-adjusted 61% and 58% reduction in triglyceride (TG) levels at six months with the 80 mg and 50 mg monthly doses, respectively (p <0.0001),” it says. It also met all key secondary endpoints in the study.

“The vast majority of participants reached less 150mg/dL, reflecting a reduction to normal TG level,” the company says. Olezarsen also showed a favorable safety and tolerability profile in the study. The most common treatment-emergent adverse event that occurred more frequently than placebo in the olezarsen groups was injection site reactions, with the majority being mild in severity, it says.

Data from the pivotal Phase 3 CORE and CORE2 studies evaluating olezarsen for treating severe hypertriglyceridemia (sHTG) are expected in the third quarter, it notes. “Following the FDA approval and encouraging launch of Tryngolza (olezarsen) for people living with familial chylomicronemia syndrome (FCS), a rare, genetic form of severely elevated TGs, these data support olezarsen’s potential to benefit the much broader population of people living with sHTG,” Ionis says.