Merck has announced a significant breakthrough in cardiovascular treatment, revealing that its experimental oral cholesterol-lowering drug, enlicitide decanoate (MK‑0616), met the main efficacy goals in two pivotal Phase 3 clinical trials, News.az reports citing Investing.
This milestone positions the drug as a potential first-in-class oral PCSK9 inhibitor, providing an alternative to currently available injectable therapies.
The late-stage trials, named CORALreef HeFH and CORALreef AddOn, assessed the drug’s ability to reduce low-density lipoprotein cholesterol (LDL‑C), commonly known as "bad cholesterol," in patients with different cardiovascular risk profiles.
In the CORALreef HeFH study, the drug was tested on patients with heterozygous familial hypercholesterolemia (HeFH) who were already on statin therapy. Results showed that MK‑0616 significantly and meaningfully lowered LDL‑C levels compared to placebo after 24 weeks.
The CORALreef AddOn trial focused on patients with elevated cholesterol despite using other non-statin treatments, including ezetimibe and bempedoic acid. Here too, MK‑0616 demonstrated superior LDL‑C reductions at the 8-week mark.
Safety outcomes across both studies were favorable, with adverse events similar to those observed in the placebo groups, reinforcing the drug's tolerability.
If approved, enlicitide decanoate would become the first oral PCSK9 inhibitor available on the market. Current PCSK9 inhibitors are only available as injections, which can limit patient adherence. The oral format is expected to offer greater convenience and improve long-term outcomes in cholesterol management.
Merck plans to present full data at upcoming medical conferences and move forward with regulatory submissions. The company is also continuing its broader CORALreef Phase 3 program, including a large cardiovascular outcomes trial involving approximately 17,000 participants.
This development underscores Merck’s commitment to advancing innovative therapies in the fight against cardiovascular disease, which remains the leading cause of death globally.
