Prevention & lipidsRandomised controlled trial
Targeting APOC3 with Olezarsen in Moderate Hypertriglyceridemia
- Randomised controlled trial
- phase 3
- international
- double-blind
- placebo-controlled
Authors' conclusion
Among patients with moderate hypertriglyceridemia and elevated cardiovascular risk, treatment with olezarsen resulted in significantly greater reduction in triglyceride levels at 6 months than placebo.
Study context
- Population
- Moderate hypertriglyceridemia (TG 150 to 499 mg per deciliter) and elevated CV risk, or severe hypertriglyceridemia (TG ≥500 mg per deciliter)primary efficacy analysis
- Participants
- 1,349 participants
- Comparison
- Olezarsen vs placebo
- Olezarsen 50 mgn = 254
- Olezarsen 80 mgn = 766
- Placebon = 329reference
- Primary endpoint
- Placebo-adjusted least-squares mean percent change in TG from baseline, among patients with moderate hypertriglyceridemia
- Follow-up
- 6 months
Primary result
As reported in the abstract
Placebo-adjusted least-squares mean change in TG
Each group vs placeboDifference, percentage points (95% CI)P value
Olezarsen 50 mg
−58.4(−65.1 to −51.7)
P < 0.001Olezarsen 80 mg
−60.6(−67.1 to −54.0)
P < 0.001Safety
Serious adverse events
- Incidence appeared similar across trial groups
Original publication
Targeting APOC3 with Olezarsen in Moderate Hypertriglyceridemia. N Engl J Med. Published 30 August 2025. doi:10.1056/nejmoa2507227
Summarised from the published abstract; every number is checked against it