Prevention & lipidsRandomised controlled trial
Olezarsen for Hypertriglyceridemia in Patients at High Cardiovascular Risk
- Randomised controlled trial
- phase 2b
- placebo-controlled
- dose cohorts 50 mg and 80 mg (1:1), then olezarsen vs placebo 3:1 within each cohort
- 24 sites in North America
Authors' conclusion
In patients with predominantly moderate hypertriglyceridemia at elevated cardiovascular risk, olezarsen significantly reduced levels of triglycerides, apolipoprotein B, and non-HDL cholesterol, with no major safety concerns identified.
Study context
- Population
- Adults with moderate hypertriglyceridemia (TG 150 to 499 mg/dL) and elevated CV risk, or severe hypertriglyceridemia (TG ≥500 mg/dL)
- Participants
- 154 adults
- Comparison
- Olezarsen vs placebo
- Primary endpoint
- Percent change in TG level from baseline, as difference between each olezarsen group and placebo
- Follow-up
- 6 months
Primary result
As reported in the abstract
Percent change in TG level
- Olezarsen 50 mg
- difference 49.3 percentage points; P < 0.001
- Olezarsen 80 mg
- difference 53.1 percentage points; P < 0.001
Secondary outcomes
APOC3, apolipoprotein B, non-HDL cholesterol, low-density lipoprotein (LDL) cholesterol
- Each dose significantly reduced APOC3, apolipoprotein B and non-HDL cholesterol vs placebo
- No significant change in LDL cholesterol
Safety
Adverse events, serious adverse events, hepatic, renal or platelet abnormalities
- Risks of adverse events and serious adverse events similar in the three groups
- Clinically meaningful hepatic, renal or platelet abnormalities uncommon, similar in the three groups
Original publication
Olezarsen for Hypertriglyceridemia in Patients at High Cardiovascular Risk. N Engl J Med. Published 7 April 2024. doi:10.1056/nejmoa2402309
Summarised from the published abstract; every number is checked against it