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Journalism of Courage
What happens when your bad cholesterol (low-density lipoprotein or LDL) is stubborn despite being on statins, a class of medication that lowers cholesterol in the blood by reducing the amount the liver produces? Now a new, experimental pill has been found to reduce the LDL by up to 60 per cent when given with statins in Phase 3 clinical trials.
High levels of LDL in the blood lead to increased deposition of plaque in the arteries, which triggers heart attacks. “The new pill, enlicitide, blocks a liver protein called PCSK9, which slows down the body’s ability to clear cholesterol. Once the PCSK9 is blocked, LDL levels plummet. Now, some PCSK9 inhibitors like evolocumab (also available in India) are used as an injectable, typically administered once every two weeks or once a month, depending on the dosage and the patient’s condition. These have been proven to lower LDL by up to 70 per cent and reduce heart attack risk too. A daily pill would be more welcome than a jab, but we have to wait for its cascading impact in reducing heart attacks,” says Dr Balbir Singh, Chairman, Cardiac Sciences, Max Healthcare.
Phase 3 trial data found that people who took the investigational drug enlicitide with their routine cholesterol-lowering drugs like statins, saw up to a 60 per cent reduction in their LDL after 24 weeks of daily treatment, according to a news release about the results. That was in comparison with people who took a placebo along with their statins. All study participants had high levels of LDL cholesterol, either with a history of a major cardiovascular event or at an increased risk of one.
The trial included 2,912 adults, with an average age of 63. Data were collected across 14 countries between August 2023 and July 2025. The findings were presented at the American Heart Association’s Scientific Sessions. Merck, the pharmaceutical company behind enlicitide, will be applying for the US Food and Drug Administration (FDA) approval early next year.
Statins can reduce bad cholesterol by up to 40 per cent, which may not be enough in some patients, who need additional backup. “This can be due to hypercholesterolemia, a genetic disorder that causes very high cholesterol levels. Even statins at their maximum doses cannot lower them. Sometimes the efficacy of statins is stunted by other prescription drugs, even supplements. At other times, there could be problems with your thyroid, liver, or kidneys,” says Dr Ranjan Shetty, lead cardiologist and medical director, Sparsh Hospitals, Bengaluru.
Besides, the functioning of a PCSK9 inhibitor and a statin is different. “The first clears LDL from the blood. On the other hand, statins block an enzyme in the liver, resulting in the liver removing more LDL cholesterol from the body. So, the dual mechanisms are the reason that they are prescribed together in stubborn cases,” says Dr Shetty.
Does that mean, in the future, PCSK9 pills can be taken on their own without depending on statins?
“No,” says Dr Singh, adding, “These are always to be had in addition to statins which do the heavy lifting. This is not a substitute.” While the injectables are expensive, a pill, he hopes, would democratise access by reducing costs. “I have been following this research. The challenge was to make the small molecules as potent as the injectables. They have done that after a decade of research,” Dr Singh says. Pills will be more convenient than injectables, which have to be kept refrigerated.
