Key takeaways:
- Topline results from two phase 3 trials of a novel oral PCSK9 inhibitor for treatment of HeFH and hyperlipidemia were positive.
- Enlicitide decanoate met its primary endpoints in both trials.
Enlicitide decanoate demonstrated meaningful LDL lowering in patients with heterozygous familial hypercholesterolemia and those with hyperlipidemia vs. placebo and other lipid-lowering therapies, Merck reported.
Topline data from the phase 3 CORALreef HeFH and CORALreef AddOn clinical trials evaluating the safety and efficacy of enlicitide decanoate (MK-0616), an investigational oral PCSK9 inhibitor, for treatment of adults with HeFH and hyperlipidemia already on lipid-lowering therapy were announced in a company press release.
CORALreef HeFH was a randomized, double-blind, placebo-controlled study in which researchers evaluated the efficacy and safety of enlicitide decanoate compared with placebo in adults with HeFH at risk for major ASCVD events already treated with a moderate- or high- intensity statin and/or other lipid-lowering therapies.
The primary endpoints were change in LDL at 24 weeks, adverse events and drug discontinuation due to an adverse event.
CORALreef AddOn was a randomized, double-blind study in which researchers evaluated the efficacy and safety of enlicitide decanoate compared with ezetimibe, bempedoic acid (Nexletol, Esperion Therapeutics) and both ezetimibe and bempedoic acid, in patients with hypercholesterolemia at risk for major ASCVD events already taking with a statin.
The primary endpoint was change from baseline in LDL at 8 weeks.
Both trials met their primary endpoint as well as all key secondary endpoints, with significant reductions in LDL among patients assigned to enlicitide decanoate vs. placebo in CORALreef HeFH and compared with ezetimibe and/or bempedoic acid in CORALreef AddOn.
The company reported no clinically meaningful differences in adverse events and serious adverse events in either trial.
The efficacy and safety of enlicitide decanoate is also being evaluated in the CORALreef Lipids and CORALreef Outcomes trials. The full results of the CORALreef clinical development program will be presented at a future scientific congress, according to the release.
Christie M. Ballantyne
“Atherosclerotic cardiovascular disease accounts for 85 percent of cardiovascular deaths. Despite available treatment options, cardiovascular-related deaths remain the leading cause of death worldwide and continue to rise,” Christie M. Ballantyne, MD, FACC, FACP, FAHA, FNLA, chief of the section of cardiovascular research and professor of medicine at Baylor College of Medicine and principal investigator of the CORALreef HeFH study, said in the release. “LDL-C is a major modifiable risk driver for atherosclerosis and prioritization of LDL-C management should be a cornerstone of cardiovascular risk prevention. Early intervention and intensification of lipid treatment would allow more patients to achieve LDL-C goals.”
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