AHA 25: CORALreef HeFH: Oral PCSK9 Inhibitor for Familial Hypercholesterolemia

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AHA Scientific Sessions 2025 - Dr Christie Ballantyne (Baylor College of Medicine, Houston, TX, US) discusses findings from the CORALreef HeFH trial, examining the efficacy and safety of enlicitide decanoate, an oral PCSK9 inhibitor, in adults with heterozygous familial hypercholesterolemia and high risk individuals .

This Phase 3, randomized, double-blind, placebo-controlled study evaluated 303 participants with heterozygous familial hypercholesterolemia who were already receiving moderate- or high-intensity statin therapy. Participants were randomized to receive either enlicitide decanoate 20 mg orally once daily or placebo for up to 52 weeks, representing a significant advancement in lipid management as the first oral PCSK9 inhibitor studied in this patient population.

Key findings showed around 50% reductions in Apolipoprotein B, reductions in LDL cholesterol, and a good safety profile. Findings were concordant across the CORALreef programme, both in patients at high risk and in patients with familial hypercholesterolemia.

Interview Questions:
1. What is the current treatment landscape for patients with heterozygous familial hypercholesterolemia, and where do oral PCSK9 inhibitors fit?
2. What were the primary objectives of the CORALreef HeFH trial?
3. What was the study design and patient population?
4. What were your key findings?
5. What are your key take-home messages for clinicians managing patients with familial hypercholesterolemia?
6. What are the next steps for this research program?

Recorded on-site at AHA Scientific Sessions 2025, New Orleans.
Editors: Jordan Rance, Yazmin Sadik
Videographer: David Ben-Harosh
Support: This is an independent interview produced by Radcliffe Cardiology.

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