MK-0616 (oral PCSK9 inhibitor) for MMN — Evidence & Clinical Trials

Overview

Treatment Details

Mechanism of Action

An investigational oral macrocyclic peptide that binds and inhibits PCSK9 — the first potentially oral PCSK9 inhibitor. Phase 2b showed >60% LDL-C reduction at 16 weeks, comparable to injectable PCSK9 inhibitors. Currently in Phase 3 CORALreef program targeting ~17,000 participants. If approved, would eliminate the need for injections for PCSK9 inhibition.

Dosing Notes

Investigational; once-daily oral tablet. Doses of 6, 12, 18, and 30 mg studied in Phase 2b.

Treatment Type

pharmaceutical

Clinical Evidence

What the Evidence Shows

Each finding below is linked to its primary source. Confidence levels reflect the quality and quantity of available evidence — not CelluTarget's endorsement of any treatment.

High: Supported by multiple robust studies or regulatory approval

Moderate: Supported by limited controlled studies or consistent case series

Low: Based on case reports, expert opinion, or early-phase data only

Moderate ConfidenceSupported by limited controlled studies or consistent case series

Phase 2b CORALreef: MK-0616 reduced LDL-C by 41–61% vs placebo across four doses at 16 weeks in patients with hypercholesterolemia across a broad spectrum of ASCVD risk, including those on high-intensity statin. Well-tolerated with no dose-dependent adverse event trends.

Verified Jul 2026

Peer Reviewed

MK-0616 Phase 2b results (JACC, 2023) — first oral PCSK9 inhibitor data

Published April 2023

View source ↗

Clinical Trials

Linked Trials2 trials

No registry ID — unregistered program

MACE composite: CV death, non-fatal MI, non-fatal stroke requiring revascularization

Target enrollment: 17000 participants

Phase 3

Recruiting