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For adults with preexisting cardiovascular disease, pelacarsen, an antisense oligonucleotide administered monthly, lowers lipoprotein(a) levels but does not reduce the occurrence of major adverse cardiovascular events, according to a study published online Nov. 7 in the New England Journal of Medicine to coincide with the American Heart Association Scientific Sessions 2026, held from Nov. 6 to 9 in Chicago.

Leslie Cho, M.D., from the Cleveland Clinic, and colleagues conducted an international, randomized, placebo-controlled trial involving patients with preexisting cardiovascular disease and a lipoprotein(a) level of at least 70 mg/dL who were randomly assigned to receive subcutaneous pelacarsen (80 mg) administered monthly or matching placebo (4,157 and 4,165 individuals, respectively). Patients were followed for a median of 4.7 years.

At baseline, the median lipoprotein(a) level was 236 nmol/L. The researchers found that at 12 months, lipoprotein(a) levels were 64.4 and 233.4 nmol/L in the pelacarsen and placebo groups, respectively. A primary endpoint event (major adverse cardiovascular event) occurred in 12.3% and 12.1% of patients in the pelacarsen and placebo groups, respectively.

A primary endpoint event occurred in 12.3% and 12.3% of patients in the pelacarsen and placebo groups, respectively, among patients with a baseline lipoprotein(a) of at least 90 mg/dL. Serious adverse events occurred in 37.3% and 41.1% of patients who received pelacarsen and placebo, respectively.

"I cannot avoid the disappointing conclusion—it didn't work," senior author Steven E.

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