An experimental drug has been developed that substantially lowers a type of dangerous cholesterol linked to higher heart attack and stroke risk.
Lepodisiran, an experimental drug developed by Eli Lilly and Company, was found to be effective against lipoprotein(a), also known as Lp(a), during the second phase of a clinical trial. Researchers say that there is currently no direct treatment available to lower Lp(a) levels.
Lp(a) is a type of cholesterol that circulates in the blood, goes undetected by routine tests, and cannot be modified with lifestyle changes, such as diet, exercise, and weight loss. The Cleveland Clinic, which led the study, referred to Lp(a) as “one of the last untreatable frontiers of cardiovascular risk.”
Lp(a) is primarily determined by genetics, in contrast to other types of cholesterol. Lp(a) has similarities to low-density lipoprotein (LDL), which is often referred to as “bad cholesterol.” While statins and other medications can reduce LDL, there are no approved medications to lower Lp(a) levels.
“There is no approved pharmacotherapy for lipoprotein(a) by regulatory authorities in any country in the world,” Dr. Steven Nissen, lead author of the study, and chief academic officer of the Heart, Vascular & Thoracic Institute at the Cleveland Clinic, told Fox News Digital.
Experts say that differences in a single gene primarily determine Lp(a), while multiple genes influence LDL cholesterol levels.
“That’s a very big difference, and LDL has a much larger environmental component,” Dr. Nissen told the digital news outlet.
The composition of the Lp(a) particle contributes to plaque buildup in arteries and promotes clotting, which significantly increases the risk of heart attack and stroke.
Lp(a) Study Design
For the clinical trial, researchers enrolled 320 participants from Argentina, China, Denmark, Germany, Japan, Mexico, the Netherlands, Romania, Spain, and the United States between November 11, 2022, and April 17, 2023. The average age of the participants was 62.
The normal level of Lp(a) is less than 75 nanomoles per liter, and the average level for people in the trial was about 250 nanomoles per liter, Dr. Nissen told Fox News Digital.
“They were very high—more than three times the upper limit of normal,” Dr. Nissen added.
The participants were randomly assigned to receive either a placebo or one or two subcutaneous injections of lepodisiran. Researchers reported no significant safety concerns during the trial. However, 12 percent of participants experienced mild injection site reactions for a short time, including pain or redness.
Results from the Phase 2 clinical trial show that a single dose of lepodisiran effectively reduced Lp(a) blood levels by 94 percent for six months. For a whole year (360 days) following one dose, Lp(a) levels decreased by 88.5 percent. According to Dr. Nissen, the therapy essentially cleared all Lp(a) from the blood. The findings were published in the New England Journal of Medicine.
“The results are very impressive,” Dr. Deepak L. Bhatt, director of Mount Sinai Fuster Heart Hospital and a professor of cardiovascular medicine at Icahn School of Medicine at Mount Sinai in New York, told Fox News Digital. Dr. Deepak was not part of the study.
While medical professionals were pleased with the trial’s results, the researchers acknowledged that the study had limitations:
• Only a small number of Black people participated in the study. According to previous studies, the Black population requires further research because they are more likely to have elevated Lp(a) concentrations than the White population.
• Only two doses of lepodisiran were administered in the trial, so the effect of more doses is not known.
Experts who were not part of the study mentioned that the trial did not show that reducing Lp(a) levels also reduces the risk of heart attacks and strokes.
“A phase 3 trial testing the clinical impact of this drug is needed to see if the large reduction of Lp(a) translates into lower rates of heart attack,” Dr. Bhatt told Fox News Digital.
To address these and other concerns, researchers say they are enrolling more Black participants in their larger Phase 3 clinical trial, which is currently underway and sponsored by Eli Lilly and Company in collaboration with Dr. Nissen and the Cleveland Clinic.
Cardiologists Urge Patients to Get Lp(a) Levels Checked
Cardiologists believe the latest discovery could eventually benefit people with high Lp(a), which is estimated to affect 64 million people in the United States and 1.4 billion people worldwide.
The European Society of Cardiology and the National Lipid Association in the United States both recommend that all adults get their Lp(a) levels checked.
“I have been checking Lp(a) levels in all patients for many years,” Dr. Bhatt told Fox News Digital.
Doctors routinely check cholesterol levels, but not Lp(a) levels.
“Many people with high Lp(a) don’t experience symptoms, and unfortunately, it is not frequently tested,” Dr. Nissen said in a news release.
As a result, people may not know that they have an elevated Lp(a —even if they maintain a healthy lifestyle, unless they get tested.
The American Heart Association (AHA) reports that Lp(a) levels are elevated in approximately 20-25 percent of people worldwide. Additionally, the AHA recommends that people talk with their doctor about getting screened if they have:
• A known family history of high Lp(a)
• Family or personal history of heart disease or premature cardiovascular disease
• Diagnosis of familial hypercholesterolemia (FH), an inherited condition that causes the body to recycle LDL, or bad cholesterol poorly
Dr. Nissen told Fox News Digital that Lp(a) only needs to be checked once in a lifetime.
“Whatever your level is when you’re 24 years old is the level when you’re 64 years old—it doesn’t change, because it’s genetic,” Dr. Nissen said. “So you only need to get it once, and if you get it early in life, then you know you’re at risk, and you can live your life accordingly.”
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