Status:
COMPLETED
A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hypercholesterolemia
Familial Hypercholesterolemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 hyperchole...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2022
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT05261126
Start Date
March 10 2022
End Date
November 28 2022
Last Update
December 9 2024
Active Locations (63)
Enter a location and click search to find clinical trials sorted by distance.
1
Westside Medical Associates of Los Angeles ( Site 0026)
Beverly Hills, California, United States, 90211
2
Clinical Trials Research ( Site 0007)
Sacramento, California, United States, 95821
3
National Research Institute (NRI) - Santa Ana ( Site 0024)
Santa Ana, California, United States, 92704
4
Excel Medical Clinical Trials ( Site 0042)
Boca Raton, Florida, United States, 33434