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Lp(a) fell sharply.
No clear heart benefit.
In people with established cardiovascular disease, pelacarsen substantially lowered lipoprotein(a), an inherited risk marker. Cardiovascular events were similar to placebo, and more people stopped treatment because of adverse events.
Primary cardiovascular events
Hazard ratio 1.0295% confidence interval 0.90–1.15
Pelacarsen12.3%
Placebo12.1%
Reported primary-event percentages; estimation method unverified.
Stopped treatment because of adverse events
Pelacarsen20.6%
Placebo7.5%
Trial context & sources
Adults with established cardiovascular disease and screening Lp(a) ≥70 mg/dL received pelacarsen 80 mg subcutaneously monthly or placebo, alongside standard secondary-prevention care. The result concerns this drug and regimen; it does not settle every Lp(a)-lowering therapy or primary prevention. Novartis discontinued the ASCVD development program in its October 16 patient-community statement, shared publicly November 2; the extension registry posted termination November 10. This is newly recovered program status, not a new trial failure.
Cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or urgent coronary revascularization requiring hospitalization.
The confidence interval spans no difference. Event percentages are reported as published by the investigator institution; exact arm denominators and whether these are crude or Kaplan–Meier estimates were not verified, so they are not rescaled to 1,000 people or used to calculate NNT. Adverse-event discontinuation is separate from serious adverse events and study withdrawal; its exact safety denominator and collection window remain unverified. The negative topline was announced September 4; these fuller numerical results were reported November 7. Direct access to the NEJM paper was unavailable for this review; the linked investigator report supplies the displayed estimates.
Investigator report · November 7, 2026NEJM paper · Direct access unavailable during reviewTrial registry · NCT04023552Original Novartis program-discontinuation letter · October 16, 2026