07:21 AM EDT, 06/09/2025 (MT Newswires) -- Merck ( MRK ) said Monday it has reported positive topline results from two Phase 3 clinical trials evaluating the safety and efficacy of enlicitide decanoate, an investigational oral PCSK9 inhibitor for treating adults with hyperlipidemia already receiving lipid-lowering therapies, including statins.

Both trials met their primary and all key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol, or LDL-C, Merck ( MRK ) said.

In the CORALreef HeFH study, enlicitide significantly reduced LDL-C levels compared with placebo in patients with heterozygous familial hypercholesterolemia who are on statins and at risk for atherosclerotic cardiovascular disease.

The CORALreef AddOn study showed "statistically significant and clinically meaningful reductions" in LDL-C with enlicitide compared with ezetimibe, bempedoic acid, and their combination in broader hyperlipidemia patients on statin therapy.

No clinically meaningful differences in adverse and serious adverse events were observed in either study, Merck ( MRK ) said.