Experimental cholesterol-lowering pill may offer new option for people on statins.

A trial of more than 2,900 high-risk patients found the experimental pill enlicitide lowered LDL cholesterol by up to 60% over six months, and Merck funded the study as it seeks FDA approval.

A new experimental pill called enlicitide sharply lowered LDL cholesterol in people at high risk of heart attack who remained on statins. Researchers reported results from a randomized trial published in the New England Journal of Medicine involving more than 2,900 participants. The pill works in a way similar to injected PCSK9 inhibitors but is taken orally and must be taken on an empty stomach. Merck funded the study and is advancing data to the FDA, which has placed the drug in an accelerated review program. Study findings: - Trial size: more than 2,900 high-risk patients were randomly assigned to daily enlicitide or a placebo in addition to standard statin therapy. - LDL reduction: participants taking enlicitide saw LDL cholesterol fall by as much as 60% over six months, with only a slight decline in effect over a year. - Safety: researchers reported no safety difference between the enlicitide and placebo groups in the trial. - Administration note: the pill must be taken on an empty stomach. - Context: injected PCSK9 inhibitors lower LDL similarly, but they are injections and only a small fraction of eligible patients use them despite recent price drops. Summary: The trial shows enlicitide can achieve large short‑term reductions in LDL cholesterol comparable to PCSK9 injections. Merck has submitted data toward FDA approval and the drug is in an accelerated review pathway, while a larger outcomes study of more than 14,000 patients is underway to evaluate effects on heart attacks, strokes and death.