A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypercholesterolemia, Familial Hypercholesterolemia

In brief

The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia. The primary hypothesis is that at least one of the four doses of enclitide chloride tested in this study is superior to placebo on percent change from baseline in LDL-C at Week 8.

Key facts

Study ID

NCT05261126

Run by

Merck Sharp & Dohme LLC

People needed

381

Starts

2022-03-10

Expected to finish

2022-11-28

Last updated by the study team

2024-12-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of clinical atherosclerotic cardiovascular disease (ASCVD), or has an ASCVD risk equivalent and/or a 10-year risk of having an ASCVD event ≥5.0%, AND has a corresponding LDL-C that falls within the protocol-specified range at screening.
• Treatment with a stable dose of one or more lipid-lowering therapies for ≥30 days before screening, or has not received treatment with any lipid-lowering therapy for ≥30 days before screening.
• A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 8 weeks after the last dose of study intervention.

You may not qualify if…

• History of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria.
• History of nephrotic syndrome.
• History of unstable angina, a myocardial infarction, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before Screening.
• Has poorly controlled diabetes mellitus, defined as hemoglobin A1C (A1C) ≥9.0% at Screening.
• History of malignancy ≤3 years before screening, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, which have no timeframe limitations relative to screening.
• Currently participating in or has previously participated in an interventional clinical study within 3 months before Screening.
• Has moderate or greater renal insufficiency.

Where it is running

• Clinical Trials Research ( Site 0007) — Sacramento, California, United States
• National Research Institute (NRI) - Santa Ana ( Site 0024) — Santa Ana, California, United States
• Excel Medical Clinical Trials ( Site 0042) — Boca Raton, Florida, United States
• Alliance for Multispecialty Research, LLC ( Site 0050) — Coral Gables, Florida, United States
• ForCare Clinical Research ( Site 0017) — Tampa, Florida, United States
• Healthcare Research Network - Chicago ( Site 0037) — Flossmoor, Illinois, United States
• Midwest Institute For Clinical Research ( Site 0036) — Indianapolis, Indiana, United States
• Cotton O'Neil Mulvane ( Site 0022) — Topeka, Kansas, United States
• L-MARC Research Center ( Site 0003) — Louisville, Kentucky, United States
• The University of Mississippi Medical Center-Clinical Research and Trials Unit ( Site 0028) — Jackson, Mississippi, United States
• Jubilee Clinical Research ( Site 0047) — Las Vegas, Nevada, United States
• New Mexico Clinical Research & Osteoporosis Center ( Site 0032) — Albuquerque, New Mexico, United States
• Mid Hudson Medical Research ( Site 0004) — New Windsor, New York, United States
• altoona center for clinical research ( Site 0045) — Duncansville, Pennsylvania, United States
• Piedmont Research Partners ( Site 0005) — Fort Mill, South Carolina, United States
• Dallas Diabetes Research Center ( Site 0012) — Dallas, Texas, United States
• Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0051) — Houston, Texas, United States
• Northeast Clinical Research of San Antonio ( Site 0014) — San Antonio, Texas, United States
• National Clinical Research, Inc-research office ( Site 0019) — Richmond, Virginia, United States
• Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0504) — München, Bavaria, Germany
• Kardiologische Gemeinschaftspraxis ( Site 0502) — Nuremberg, Bavaria, Germany
• Ambulantes Herzzentrum Kassel ( Site 0501) — Kassel, Hesse, Germany
• Universitätsklinikum Leipzig ( Site 0500) — Leipzig, Saxony, Germany
• Charité Campus Virchow-Klinikum ( Site 0505) — Berlin, Germany
• Westside Medical Associates of Los Angeles ( Site 0026) — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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