Endocrinology, diabetes & metabolism
Efficacy and Safety of Enlicitide in Hypercholesterolemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
By Farhan M, Murtaza M, Rasool MM and 8 others.
Abstract
Background
Atherosclerotic cardiovascular disease remains a leading cause of global mortality, with low-density lipoprotein cholesterol (LDL-C) reduction being the cornerstone of prevention. Despite effective therapies, many high-risk patients do not achieve recommended LDL-C targets. Enlicitide (MK-0616), an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, offers a potential alternative to injectable PCSK9-directed therapies.
Objective
To evaluate the efficacy and safety of enlicitide in adults with hypercholesterolemia and assess its dose-dependent effects on lipid parameters.
Methods
We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) according to PRISMA 2020 guidelines. PubMed, Embase, Scopus, ClinicalTrials.gov, and Google Scholar were searched from inception through March 2026. Random-effects meta-analysis using restricted maximum likelihood estimation was performed. The primary outcome was the percentage change in LDL-C from baseline. Secondary outcomes included non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), lipoprotein(a), triglycerides, and safety outcomes. Risk of bias and certainty of evidence were assessed using RoB 2.0 and GRADE.