Details of the SBP

General Information of Synthetic Binding Protein (SBP) (ID: SBP003586)
SBP Name
Macrocyclic peptide anti-PCSK9 MK-0616
Synonyms
Macrocyclic peptide MK-0616
Design Method Traditional methods (Site-directed mutagenesis and/or Directed evolution)
Selection Method mRNA display
Highest Status Phase III
Protein Scaffold Information of This SBP
Scaffold ID PS044
Scaffold Info
[1]
Scaffold Name Macrocyclic peptide
Scaffold Class Non-Antibody
Fold Type Beta-Sheets + Loops
Binding Target(s) of This SBP (BTS)
BTS Name Details Mechanism Application Affinity Research Organization Ref
Proprotein convertase subtilisin/kexin type 9
BTS Info
Inhibitor Tools for reducing plasma low-density lipoprotein cholesterol Ki: 0.005 nM MRL, Merck & Co., Inc. [1]
Clinical Trial Information of This SBP
NCT05261126 Click to show the Detail
Indication Hypercholesterolemia; Familial Hypercholesterolemia
Phase Phase II
Title A Study of the Efficacy and Safety of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
Status Completed
Sponsor Merck Sharp & Dohme LLC
NCT05934292 Click to show the Detail
Indication Hypercholesterolaemia
Phase Phase I
Title Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study 2 (MK-0616-020)
Status Completed
Sponsor Merck Sharp & Dohme LLC
NCT05952856 Click to show the Detail
Indication Hypercholesterolemia; Familial Hypercholesterolemia
Phase Phase III
Title A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
Status Active, not recruiting
Sponsor Merck Sharp & Dohme LLC
NCT05952869 Click to show the Detail
Indication Hypercholesterolemia; Familial Hypercholesterolemia
Phase Phase III
Title A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH
Status Active, not recruiting
Sponsor Merck Sharp & Dohme LLC
NCT06008756 Click to show the Detail
Indication Arteriosclerosis; Hypercholesterolaemia
Phase Phase III
Title Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
Status Recruiting
Sponsor Merck Sharp & Dohme LLC
NCT06450366 Click to show the Detail
Indication Hypercholesterolemia
Phase Phase III
Title A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018) CORALreef AddOn
Status Recruiting
Sponsor Merck Sharp & Dohme LLC
NCT06492291 Click to show the Detail
Indication Hypercholesterolemia
Phase Phase III
Title Open-label Extension Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
Status Not yet recruiting
Sponsor Merck Sharp & Dohme LLC
References
1 Orally Bioavailable Macrocyclic Peptide That Inhibits Binding of PCSK9 to the Low Density Lipoprotein Receptor. Circulation. 2023 Jul 11;148(2):144-158.