Experimental cholesterol-lowering pill may offer new option for millions
[February 05, 2026]
By LAURAN NEERGAARD
WASHINGTON (AP) — A new kind of pill sharply reduced artery-clogging
cholesterol in people who remain at high risk of heart attacks despite
taking statins, researchers reported Wednesday.
It’s still experimental but the pill helps rid the body of cholesterol
in a way that today can be done only with injected medicines. If
approved by the Food and Drug Administration, the pill, named enlicitide,
could offer an easier-to-use option for millions of people.
Statins block some of the liver’s production of cholesterol and are the
cornerstone of treatment. But even taking the highest doses, many people
need additional help lowering their LDL, or “bad,” cholesterol enough to
meet medical guidelines.
In a major study, more than 2,900 high-risk patients were randomly
assigned to add a daily enlicitide pill or a dummy drug to their
standard treatment. The enlicitide users saw their LDL cholesterol drop
by as much as 60% over six months, researchers reported in the New
England Journal of Medicine.
There are other pills that patients can add to their statins “but none
come close to the degree of LDL cholesterol lowering that we see with
enlicitide,” said study lead author Dr. Ann Marie Navar, a cardiologist
at UT Southwestern Medical Center.
That benefit dropped only slightly over a year, and there was no safety
difference between those taking the pill or placebo, researchers found.
One caveat: The pill must be taken on an empty stomach.
Heart disease is the nation’s leading cause of death and high LDL
cholesterol, which causes plaque to build up in arteries, is a top risk
factor for heart attacks and strokes. While an LDL level of 100 is
considered fine for healthy people, doctors recommend lowering it to at
least 70 once people develop high cholesterol or heart disease — and
even lower for those at very high risk.
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 Statin pills like Lipitor and
Crestor, or their cheap generic equivalents, are highly effective at
lowering LDL. For additional help, some powerful injected drugs work
differently, blocking a liver protein named PCSK9 that limits the
body’s ability to clear cholesterol from blood. Yet only a small
fraction of people who could benefit from PCSK9 inhibitors use them.
While prices for the costly shots have dropped recently, patients
still may dislike administering shots and Navar said they’re more
complex for doctors to prescribe.
Merck funded Wednesday’s study, which provides some of the final
data needed to seek FDA approval of enlicitide. The FDA has added
the drug to a program promising ultra-fast reviews.
The research offers “compelling evidence” that the new pill lowers
cholesterol about as much as those PCSK9 shots, Dr. William Boden of
Boston University and the VA New England Healthcare System, who
wasn’t involved with the study, wrote in the journal.
Boden cautioned there’s no data yet showing the pill’s
cholesterol-reduction translates into fewer heart attacks, strokes
and death. That takes much longer than a year to prove. Merck has a
study of more than 14,000 patients underway to tell.
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