A Powerful New Pill Targets 'Bad' Cholesterol
- Nov 21
- 2 min read
A powerful new treatment has emerged in the effort to reduce high cholesterol and the associated risk of heart health problems. High cholesterol can lead to fatty deposits (plaque) inside arteries, restricting blood flow and increasing the risk of heart attacks and strokes. For many patients, routine statin medications and lifestyle changes are not enough to reach target cholesterol levels.
New Phase 3 trial data shows that the investigational drug enlicitide decanoate (also referred to as enlicitide), taken as a once-daily pill, achieved significant reductions in low-density lipoprotein cholesterol (LDL-C)—the ‘bad’ type.
The trials included adults who had elevated LDL cholesterol levels despite being on a stable course of lipid-lowering therapies, such as statins. In one trial focused on individuals with Heterozygous familial hypercholesterolemia (HeFH)—a common genetic disorder characterized by elevated LDL-C from birth—the drug reduced LDL-C by an average of 58.2 percent after 24 weeks. Overall, the daily treatment was found to reduce LDL-C by up to 60% after 24 weeks, reductions that were sustained through 52 weeks. Those who took a placebo instead saw a slight rise in LDL-C levels.
Enlicitide is an effective and well-tolerated treatment that belongs to a class of drugs known as PCSK9 inhibitors. This mechanism works by limiting the effectiveness of the PCSK9 blood protein, thereby helping the liver clear away LDL-C properly. Statins, by contrast, lower LDL cholesterol by blocking an enzyme in the liver. Because enlicitide works via a different mechanism, adding it to statins is expected to further reduce LDL cholesterol.
Currently available PCSK9 inhibitors are administered via injection. However, enlicitide is notable as the "first oral PCSK9 inhibitor to complete Phase 3 trials," offering an option for administration that may be preferable to some patients. Adherence to the once-daily oral intervention was notably high among participants (98%).
Beyond the dramatic LDL-C reductions, the adults taking enlicitide also showed reductions in other markers, including a 53% reduction in a combination of all other cholesterol (excluding HDL) and a 50% decrease in ApoB.
Concerning safety, side effects were limited and similar between the treatment and placebo groups. Serious adverse events, including gastrointestinal disorders and certain infections, were balanced across both the enlicitide and placebo arms. Experts noted this similarity provided reasonable assurance of no major or high-frequency adverse events.
The drug still requires regulatory approval before prescription. Merck, the pharmaceutical company behind enlicitide, plans to apply for US Food and Drug Administration (FDA) approval early next year.
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Keywords: 'Bad' Cholesterol
'Bad' Cholesterol
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