clinical trial · NCT06450366
A Study to Evaluate the Efficacy and Safety of Enlicitide (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)
Merck Sharp & Dohme LLC·phase3·completed·n = 301
HypercholesterolemiaEnlicitideEzetimibeBempedoic AcidPlacebo for EnlicitidePlacebo for EzetimibePlacebo for Bempedoic Acid
brief summary
The main purpose of this study is to assess whether enlicitide is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia, and to evaluate its safety and tolerability. The primary study hypotheses are enlicitide is superior to ezetimibe, bempedoic acid, and ezetimibe + bempedoic acid on mean percent change from baseline in LDL-C at week 8.
started
Jul 8, 2024
primary completion
Feb 14, 2025
completion
Mar 28, 2025
last updated
Mar 27, 2026
official title
A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol