Merck Launches Phase III Clinical Trial in China for Oral PCSK9 Inhibitor Enlicitide (MK-0616)

On October 18, MSD registered a randomized, double-blind, placebo-controlled Phase III study (registration number: CTR20233296) on the Drug Clinical Trial Registration and Information Disclosure Platform, aiming to evaluate the efficacy and safety of the oral PCSK9 inhibitor MK-0616 (enlicitide) in treating adult hypercholesterolemia.

This study is part of the international multicenter clinical trial MK-0616-013 and plans to enroll 170 adult patients with hypercholesterolemia in China. MK-0616-013 was initiated on August 10 this year and aims to recruit 2,760 patients across multiple countries, including the United States, China, Japan, and Argentina, with an expected completion date of September 2025. The primary endpoints of the study are the mean percentage change in low-density lipoprotein cholesterol (LDL-C) levels from baseline at week 24 and the incidence of adverse events and discontinuation rate due to adverse events at the end of the study.

MK-0616 is an oral cyclic peptide PCSK9 inhibitor developed by MSD. PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) is primarily expressed in the liver and acts as an accomplice in elevating "bad cholesterol" LDL-C. PCSK9 can bind to receptors on the surface of hepatocytes responsible for clearing LDL-C, causing most LDL-C to remain unabsorbed.

Results from a Phase IIb study (N=381) in patients with hypercholesterolemia showed that by Week 8 of treatment, patients receiving different doses of MK-0616 achieved statistically significant reductions in LDL-C levels. The reductions were 41.2%, 55.7%, 59.1%, and 60.9% for the 6mg, 12mg, 18mg, and 30mg dose groups, respectively.

Currently, four PCSK9-targeted drugs have been approved globally: Inclisiran (Novartis), Tolletuzumab (Innovent Biologics), Evolocumab (Amgen/Astellas), and Alirocumab (Regeneron/Sanofi). All four products are now available in China. Junshi Biosciences' "Ongevibart", Akeso Biopharma's "Evinucimab", and Hengrui Medicine's "Recarcimab" are in the application stage for market approval. Additionally, Salubris' "GM-0023" and Haisen Bio's "Lerodalcibep" have entered Phase III trials. The competition in the PCSK9 field has reached a fever pitch.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reproduce it, please leave a message to the WeChat Official Account or send a message, and specify the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Exciting Preview

Online Live Streaming & Offline Salon