Experimental Cholesterol‑Lowering Pill May Offer New Option for Millions

An experimental once‑daily pill called enlicitide has demonstrated dramatic reductions in LDL (“bad”) cholesterol in high‑risk patients already on statin therapy, hinting at a potential new oral treatment option that could benefit millions worldwide if approved by regulators. Top cardiologists say the results — showing LDL reductions rivaling injected therapies — could reshape cardiovascular care.

By Robert Kim – Staff Correspondent

Last Updated: Feb. 3, 2026

A Novel Oral Cholesterol Therapy

In a major clinical trial involving more than 2,900 high‑risk patients, scientists tested enlicitide, a new cholesterol‑lowering pill designed to help the body clear LDL cholesterol — the type linked most strongly to heart disease and stroke. Unlike injectable therapies currently used for patients who don’t reach target LDL levels with statins alone, enlicitide works by inhibiting a liver protein involved in cholesterol metabolism, but in an oral form. Patients taking enlicitide alongside their existing statin regimen experienced LDL cholesterol reductions of up to 60% over six months, a far larger effect than traditional oral medications have achieved. :contentReference[oaicite:1]{index=1}

Why This Matters for Patients

Statins remain the cornerstone of cholesterol‑lowering therapy, effectively preventing heart attacks and strokes for many individuals. Yet even at high doses, a significant number of patients do not achieve recommended LDL targets. Injectable drugs that block PCSK9, a liver protein that limits cholesterol clearance, can dramatically lower LDL levels but are underused because of cost, complexity, and patient reluctance to use injections. An effective oral alternative like enlicitide could make advanced cholesterol control more accessible to a broader population, improving adherence and potentially reducing cardiovascular events if long‑term benefits are confirmed. :contentReference[oaicite:2]{index=2}

Safety and Study Details

The clinical trial found no meaningful safety differences between people taking enlicitide and those receiving a placebo, although one important detail is that patients must take the pill on an empty stomach to achieve optimal effect. The benefit persisted over roughly a year of follow‑up, and researchers reported that this sustained LDL reduction was among the most pronounced seen with any oral agent to date. However, experts caution that while LDL lowering is strongly correlated with reduced cardiovascular risk, definitive evidence that enlicitide reduces heart attacks, strokes, or mortality will require larger, longer‑term studies. :contentReference[oaicite:3]{index=3}

Regulatory Path and Future Research

Merck, the pharmaceutical company sponsoring the enlicitide trials, has submitted data that could support seeking approval from the U.S. Food and Drug Administration (FDA). The FDA has included enlicitide in a fast‑review program that may accelerate regulatory evaluation. Meanwhile, an ongoing, large‑scale trial involving over 14,000 patients aims to determine whether the striking LDL reductions seen with enlicitide translate into fewer cardiovascular events and deaths — the gold standard for establishing clinical benefit. :contentReference[oaicite:4]{index=4}

Implications for Global Heart Disease Burden

Heart disease remains the world’s leading cause of death, with high LDL cholesterol a major risk factor. Experts estimate that many millions of people struggle to achieve target cholesterol levels despite existing therapies. If approved and widely adopted, an effective oral PCSK9 inhibitor like enlicitide could fill a significant treatment gap, changing how clinicians approach lipid management and offering new hope for millions living with cardiovascular risk. :contentReference[oaicite:5]{index=5}