Merck’s Non-Statin Cholesterol Drug Performs Well in Trial, Company Says

The oral drug was evaluated in a phase 3 trial.

Employees walk past a Merck sign in front of the company's building in Summit, N.J, in an undated file photograph. Kena Betancur/Getty Images

A cholesterol drug made by Merck that is not a statin met the primary goal of a late-stage clinical trial, the New Jersey-based company and researchers it works with said on March 30.

The oral drug, known as enlicitide, reduced low-density lipoprotein cholesterol (LDL-C) among people who took it, compared with arms that took available oral non-statin therapies such as bempedoic acid, according to trial results published in the Journal of the American College of Cardiology. Each arm also took statins.

The phase 3 trial was called CORALreef AddOn. It featured 301 participants and was randomized and double-blind.

Enlicitide reduced LDL-C by 56.7 percent when compared with bempedoic acid. It reduced LDL-C by 36 percent when compared with ezetimibe. And it reduced LDL-C by 28.1 percent when compared with a combination of bempedoic acid and ezetimibe.

The study showed that “enlicitide can significantly reduce LDL-C compared to established oral non-statin treatment options,” Alberico Catapano, the lead author of the study and a professor of pharmacology at the University of Milan, said in a statement.

He said that the drug “may help close gaps in lipid management by enabling robust LDL-C lowering among at-risk patients not at goal on statin therapy.”

Adverse events were similar across the treatment groups, according to the researchers.

Two previous trials found that enlicitide reduced cholesterol in recipients, compared with placebo.

“The consistency of the results from CORALreef AddOn, together with the data from CORALreef Lipids and CORALreef HeFH, further establish the efficacy and safety profile of enlicitide as a promising potential treatment solution for patients in need of further LDL-C reduction,” Dr. Joerg Koglin, a senior vice president at Merck, said in a statement.

Enlicitide is taken once a day. It is part of a new class of drugs that target a protein called proprotein convertase subtilisin/kexin type 9. The drugs are designed for patients who need additional help lowering cholesterol beyond statins, a class of drugs that target an enzyme the liver uses to make cholesterol, and dietary changes.

Food and Drug Administration officials in December 2025 chose enlicitide for a pilot program that aims to reduce review times by pre-reviewing submitted information and taking other steps to remove inefficiencies. At the time, Dr. Marty Makary, the FDA’s commissioner, said that enlicitide “may significantly contribute to our goal of improving the accessibility and affordability of healthcare in America.”

“Merck looks forward to the possibility of bringing enlicitide ... to patients with hypercholesterolemia as quickly as possible,” the company said in a March 30 statement.