Phase 2
Completed N=381
A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
Source: ClinicalTrials.gov NCT05261126 ↗Enrolled (actual)
381
Serious AEs
2.1%
Results posted
Dec 2023
Primary outcomePrimary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8 — -40.0; -54.5; -57.9; -59.7 Percentage Change — p=<0.001
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 8 |
-40.0; -54.5; -57.9; -59.7; 1.2 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experienced One or More Adverse Events (AEs) |
44.2; 39.5; 43.4; 42.1; 44.0 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Intervention Due to AEs |
2.6; 0.0; 2.6; 2.6; 1.3 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 8 |
-32.8; -45.8; -48.7; -51.8; 0.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 8 |
-34.4; -49.0; -51.8; -54.3; 1.5 | <0.001 sig |
| SECONDARY Percentage of Participants With LDL-C Value at Goal at Week 8 |
80.5; 85.5; 90.8; 90.8; 9.3 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05261126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.