Heart disease remains one of the leading causes of death around the world, largely driven by high levels of low-density lipoprotein cholesterol, often called “bad” cholesterol.
When LDL cholesterol stays high for many years, it can slowly build up inside blood vessel walls. This buildup narrows the vessels and makes them stiff, a process that increases the risk of heart attacks and strokes.
Doctors have known for decades that lowering LDL cholesterol is one of the most effective ways to protect the heart and brain, yet many people still struggle to reach healthy cholesterol levels.
A new experimental pill called enlicitide may soon change that. In a large late-stage clinical trial, enlicitide lowered LDL cholesterol levels by as much as 60 percent.
The results were published in a major medical journal and suggest that this pill, if approved, could help millions of people lower their risk of heart attacks and strokes with a simple once-daily medication.
For many years, statins have been the main treatment for high cholesterol. These drugs reduce the amount of cholesterol the liver makes and have saved countless lives.
However, even with the strongest statins, many patients do not reach the cholesterol targets recommended by doctors, especially people who already have heart disease or are at very high risk.
Some patients also stop taking statins because of side effects or concerns about long-term use. This has created a large gap between what medical guidelines recommend and what actually happens in everyday care.
The story behind enlicitide begins with decades of cholesterol research. Scientists discovered that the liver removes LDL cholesterol from the blood using special receptors on liver cells.
Later, researchers identified a protein called PCSK9, which reduces the number of these receptors and makes it harder for the body to clear LDL cholesterol. People who naturally produce less PCSK9 were found to have very low cholesterol levels and a much lower risk of heart disease, without apparent harm.
This discovery led to the development of powerful injectable drugs that block PCSK9. These treatments can lower LDL cholesterol by about 60 percent and are very effective. However, they require injections and are still not widely used.
Many patients and doctors hesitate to use injectable medications, even when they work well. Cost and access issues also slowed their adoption in the past.
Enlicitide works on the same biological pathway but in a different and simpler way for patients. It binds to PCSK9 in the bloodstream, preventing it from interfering with LDL receptors. The key difference is that enlicitide comes as a pill that can be taken once a day, rather than an injection.
To test how well the drug works, researchers studied nearly 3,000 adults who either already had hardened arteries or were at high risk of developing heart disease.
Most participants were already taking statins, yet their average LDL cholesterol levels were still higher than recommended. Some had levels far above what doctors consider safe for long-term heart health.
After 24 weeks of treatment, patients taking enlicitide saw their LDL cholesterol drop by about 60 percent compared with those taking a placebo. The drug also lowered other harmful blood fats that are linked to heart disease. These improvements remained stable during a full year of follow-up, suggesting that the effect is not short-lived.
What makes these results especially important is that this level of cholesterol reduction has never been achieved before with an oral medication. Until now, such dramatic reductions were only possible with injectable drugs. A pill that delivers similar benefits could make advanced cholesterol treatment far more accessible and acceptable to patients.
Another large study is already underway to confirm whether lowering cholesterol with enlicitide actually leads to fewer heart attacks and strokes. While past research strongly suggests that large LDL reductions translate into fewer cardiovascular events, this outcome trial is essential before the drug can be fully approved for widespread use.
In reviewing and analyzing these findings, the study represents a major step forward in heart disease prevention. The trial included a large and realistic patient population, many of whom reflect the challenges doctors see every day in clinics.
The size of the cholesterol reduction is impressive and clinically meaningful. However, it is important to note that lowering cholesterol is a surrogate outcome. The final proof will come from showing that patients live longer and suffer fewer heart attacks and strokes.
If future trials confirm these benefits and the drug is approved, enlicitide could reshape cholesterol treatment by offering a powerful, convenient option for patients who cannot reach their goals with existing therapies.
It would not replace statins but could work alongside them, helping close the long-standing gap between treatment guidelines and real-world results. For patients and doctors alike, this new pill may represent a turning point in the ongoing fight against cardiovascular disease.
If you care about heart health, please read studies about top 10 foods for a healthy heart, and how to eat right for heart rhythm disorders.
For more health information, please see recent studies about how to eat your way to cleaner arteries, and salt and heart health: does less really mean more?
The study can be found in New England Journal of Medicine.
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