Novartis, Amgen and Eli Lilly are testing Lp(a)-lowering drugs in Phase 3 trials, with Novartis results expected to help define the field.
Novartis, Amgen and Eli Lilly are pushing a little-known inherited cholesterol particle into late-stage testing, betting that drugs that sharply lower lipoprotein(a), or Lp(a), can prevent heart attacks and open a new market in cardiology.
The stakes are unusually large because elevated Lp(a) is estimated to affect one in five people worldwide, yet patients have few ways to lower it. Unlike LDL cholesterol, Lp(a) levels are driven almost entirely by genetics, so diet and exercise do not change the number in the same way.
The key question now is not whether the drugs lower Lp(a). Novartis, Amgen and Lilly have shown experimental therapies can reduce levels by more than 80%. Their Phase 3 trials are designed to prove something more important: whether those reductions translate into fewer heart attacks, strokes and other cardiovascular events.
Novartis is first in line with pelacarsen, developed with Ionis, in the Phase 3 Horizon trial. Chief Executive Vas Narasimhan said on the company’s February earnings call that the data should be unblinded around the middle of the year. The trial was delayed by a year after participants experienced cardiovascular events more slowly than expected.
Dr. Steve Nissen, chief academic officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic and principal investigator of Novartis’ Horizon trial, warned against assuming that lower Lp(a) will automatically mean better outcomes. “History has taught us you can’t make assumptions,” Nissen said, pointing to earlier hopes around raising HDL cholesterol that did not translate into clinical benefit.
If the hypothesis holds up, analysts see a significant commercial opportunity. Consensus estimates from Evaluate put potential annual sales for the drugs at $5.6 billion by 2032. But the market may take time to develop because testing remains uncommon: Less than 1% of U.S. adults were tested for Lp(a) in 2024, according to one study of electronic health records.
Leading cardiology organizations have recently recommended that every adult get tested for Lp(a) at least once, but some doctors may hesitate when there is no approved Lp(a)-lowering medicine to prescribe. Current advice focuses on controlling related risks, including LDL cholesterol, blood pressure, obesity and diabetes.
Amgen’s olpasiran and Lilly’s lepodisiran are also in Phase 3 trials, but their major readouts are farther out. Amgen now plans to provide an update on timing in early 2027, while Lilly expects data in 2029. Until Novartis reports results, the industry’s next cholesterol bet remains promising but unproven.
Comments (0)