Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

NCT05952856

CompletedPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Hypercholesterolemia, Familial Hypercholesterolemia

Interventions: Enlicitide Decanoate, Placebo

Countries: United States, Argentina, China, Colombia, Germany, Israel, Italy, Japan

The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with hypercholesterolemia. The primary hypothesis is that enlicitide decanoate is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL.
* Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance
* If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change.

Exclusion Criteria:

* Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
* Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
* Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
* Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout
Locations (168)
  • Daphne, Alabama, United States
  • Foley, Alabama, United States
  • Phoenix, Arizona, United States
  • Beverly Hills, California, United States
  • Sacramento, California, United States
  • San Bernardino, California, United States
  • Washington D.C., District of Columbia, United States
  • Boca Raton, Florida, United States
  • Coral Gables, Florida, United States
  • Fort Myers, Florida, United States
  • Hallandale, Florida, United States
  • Jacksonville, Florida, United States
  • Miramar, Florida, United States
  • Tampa, Florida, United States
  • Macon, Georgia, United States
  • Flossmoor, Illinois, United States
  • Evansville, Indiana, United States
  • Indianapolis, Indiana, United States
  • Lexington, Kentucky, United States
  • Louisville, Kentucky, United States
  • Covington, Louisiana, United States
  • Rockville, Maryland, United States
  • Gulfport, Mississippi, United States
  • Hazelwood, Missouri, United States
  • Las Vegas, Nevada, United States
  • Las Vegas, Nevada, United States
  • Albuquerque, New Mexico, United States
  • East Syracuse, New York, United States
  • New York, New York, United States
  • Fargo, North Dakota, United States
  • + 138 more on CT.gov