First Oral, Needle-Free PCSK9 Achieves 60% LDL Reduction—Matching Injectables: AHA 2025
First Oral, Needle-Free PCSK9 Achieves 60% LDL Reduction—Matching Injectables: AHA 2025
Source:
Source: AHA Newsroom, Nov 10, 2025 — AHA Scientific Sessions 2025
Keynotes :
1. New oral PCSK9 inhibitor (Enlicitide decanoate) lowers LDL up to 60%—first PCSK9 option without injections.
2. CORALreef Lipids trial: ~3,000 high-risk patients (on statins or statin-intolerant), 24 weeks, 14 countries.
3. Results:
• LDL ↓ up to 60%
• ApoB ↓ 50%
• Lp(a) ↓ 28%
4. Safety: Side-effects similar to placebo; well tolerated.
5. Effectiveness matches injectable PCSK9 inhibitors, offering a needle-free alternative.
6. Regulatory plan: Merck will submit data from CORALreef Lipids, HeHF, and AddOn to FDA and global agencies.
