Investigational Drug Reduces Lp(a) in High-Risk Adults: Daily Dose

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On November 19, 2024, we reported on findings from a phase 2 study presented at the 2024 American Heart Association Scientific Sessions that examined the effect of muvalaplin on lipoprotein(a) (Lp[a]) levels and assessed safety and tolerability.

The study

Authors of the placebo-controlled, randomized, double-blind trial enrolled 233 people with Lp(a) concentrations of 175 nmol/L or greater with atherosclerotic cardiovascular disease, diabetes, or familial hypercholesterolemia from 43 sites in Asia, Europe, Australia, Brazil, and the US between December 2022 and November 2023.

The participants received either orally administered muvalaplin at dosages of 10 mg/d (n = 34), 60 mg/d (n = 64), or 240 mg/d (n = 68), or placebo (n = 67) for 12 weeks. The primary endpoint was the placebo-adjusted percentage change from baseline in Lp(a) molar concentration at week 12.

The findings

• In the traditional blood test, muvalaplin reduced Lp(a) by 70% compared with placebo, and it reduced Lp(a) by 85.5% in a new test that evaluates “intact” Lp(a) particles, accounting for those particles that might attach to the drug.

• Treatment with muvalaplin helped 97% of participants to bring Lp(a) levels below 125 nmol/L, as measured by the intact Lp(a) particle test, or about 82% of what they measured with the traditional blood test.

• Compared with placebo, muvalaplin lowered ApoB by as much as 16% with no change in high-sensitivity C-reactive protein, which would have indicated heart attack or stroke risk.

Authors' comment

"Future studies are needed to determine whether muvalaplin reduces clinical events and plays a role in the prevention of cardiovascular disease."

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