MK-0616 / Merck (MSD), UCB 
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  • ||||||||||  MK-0616 / Merck (MSD), UCB
    Review, Journal:  Oral PCSK9 Inhibitors. (Pubmed Central) -  Mar 27, 2024   
    Clinical trial data on the safety and efficacy of MK-0616 are promising and report LDL-C-lowering efficacy comparable to that provided by injectable PCSK9 inhibitors. Ongoing and future studies of oral PCSK9 inhibitors in development will evaluate the safety, efficacy, and effectiveness of these agents and their potential role in preventing cardiovascular disease events.
  • ||||||||||  MK-0616 / Merck (MSD), UCB
    Trial completion:  MK-0616 (Oral PCSK9 Inhibitor) Renal Impairment Study 2 (MK-0616-020) (clinicaltrials.gov) -  Feb 7, 2024   
    P1,  N=33, Completed, 
    Ongoing and future studies of oral PCSK9 inhibitors in development will evaluate the safety, efficacy, and effectiveness of these agents and their potential role in preventing cardiovascular disease events. Active, not recruiting --> Completed
  • ||||||||||  Journal:  PCSK9-directed therapies: an update. (Pubmed Central) -  Jan 26, 2024   
    Long-term inhibition of PCSK9 with monoclonal antibodies is safe and conveys sustained cardiovascular benefit. Novel strategies to inhibit PCSK9 function such as orally available drugs, RNA targeting, and one-time treatment with gene editing may further enhance the therapeutic armamentarium and enable novel preventive strategies.
  • ||||||||||  MK-0616 / Merck (MSD), UCB
    Enrollment closed, Trial completion date, Trial primary completion date:  MK-0616 (Oral PCSK9 Inhibitor) Renal Impairment Study 2 (MK-0616-020) (clinicaltrials.gov) -  Jan 17, 2024   
    P1,  N=36, Active, not recruiting, 
    Novel strategies to inhibit PCSK9 function such as orally available drugs, RNA targeting, and one-time treatment with gene editing may further enhance the therapeutic armamentarium and enable novel preventive strategies. Recruiting --> Active, not recruiting | Trial completion date: Jun 2024 --> Jan 2024 | Trial primary completion date: Jun 2024 --> Jan 2024
  • ||||||||||  Nexletol (bempedoic acid) / Esperion Therap, Otsuka, Daiichi Sankyo, Repatha (evolocumab) / Amgen, Astellas, MK-0616 / Merck (MSD)
    Review, Journal:  Highlights of Cardiovascular Disease Prevention Studies Presented at the 2023 American College of Cardiology Conference. (Pubmed Central) -  May 7, 2023   
    The YELLOW III was a single-arm study that evaluated the effect of Evolocumab on coronary plaque characteristics in patients with stable coronary artery disease (CAD)...A Phase 2B RCT compared the efficacy of an oral PCSK9i, MK-0616, in reducing LDL-C as compared to a placebo. The late-breaking clinical science presented at the 2023 conference of the ACC paves the way for an evidence-based alternative to statin therapy and provides data on several common clinical scenarios encountered in daily practice.
  • ||||||||||  macrocyclic peptide / Merck (MSD)
    Journal:  Orally Bioavailable Macrocyclic Peptide That Inhibits Binding of PCSK9 to the Low Density Lipoprotein Receptor. (Pubmed Central) -  May 1, 2023   
    The late-breaking clinical science presented at the 2023 conference of the ACC paves the way for an evidence-based alternative to statin therapy and provides data on several common clinical scenarios encountered in daily practice. This work validates the use of mRNA display technology for identification of novel oral therapeutic agents, exemplified by the identification of an oral PCSK9 inhibitor, which has the potential to be a highly effective cholesterol lowering therapy for patients in need.
  • ||||||||||  MK-0616 / Merck (MSD), UCB
    Enrollment closed:  A Study of MK-0616 in Participants With Moderate Renal Impairment (MK-0616-007) (clinicaltrials.gov) -  Apr 28, 2023   
    P1,  N=18, Active, not recruiting, 
    This work validates the use of mRNA display technology for identification of novel oral therapeutic agents, exemplified by the identification of an oral PCSK9 inhibitor, which has the potential to be a highly effective cholesterol lowering therapy for patients in need. Recruiting --> Active, not recruiting
  • ||||||||||  MK-0616 / Merck (MSD)
    Clinical, P2b data, Journal:  Efficacy and safety of the oral PCSK9 inhibitor MK-0616: a phase 2b randomized controlled trial. (Pubmed Central) -  Mar 9, 2023   
    P2b
    Recruiting --> Active, not recruiting MK-0616 demonstrated statistically significant and robust, dose-dependent placebo-adjusted reductions in LDL-C at Week 8 of up to 60.9% from baseline and was well tolerated over 8 weeks of treatment and an additional 8 weeks of follow up.
  • ||||||||||  macrocyclic peptide / Merck (MSD), MK-0616 / Merck (MSD)
    Invention of MK-0616 a macrocyclic peptide oral PCSK9 inhibitor (Sagamore Ballroom 2 (Indiana Convention Center)) -  Feb 14, 2023 - Abstract #ACSSp2023ACS_SP_10303;    
    MK-0616 demonstrated statistically significant and robust, dose-dependent placebo-adjusted reductions in LDL-C at Week 8 of up to 60.9% from baseline and was well tolerated over 8 weeks of treatment and an additional 8 weeks of follow up. This presentation will highlight how Merck