Merck (NYSE: MRK), which is referred to as MSD outside of the US and Canada, released promising results from its crucial Phase 3 CORALreef HeFH trial. The study discovered that in people with heterozygous familial hypercholesterolaemia (HeFH), enlicitide decanoate, an experimental once-daily oral PCSK9 inhibitor, dramatically decreased low-density lipoprotein cholesterol (LDL-C), also known as “bad cholesterol.”
The late-breaking data, which was simultaneously published in the Journal of the American Medical Association and presented on Sunday at the American Heart Association (AHA) Scientific Sessions 2025, revealed that patients receiving enlicitide had a 59.4% decrease in LDL-C at 24 weeks when compared to those receiving a placebo.
Given that enlicitide may become the first-in-class licensed oral PCSK9 inhibitor, these findings represent a major advancement. Injections are now used to give PCSK9 inhibitors.
About 1 in 250 people have heterozygous familial hypercholesterolaemia, a prevalent hereditary condition marked by persistently elevated LDL-C values.
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303 adults with HeFH who were already on stable baseline lipid-lowering medications, such as statins, were enrolled in the randomised, double-blind, placebo-controlled CORALreef HeFH investigation.
Other critical cardiovascular risk factors were statistically significantly reduced at 24 weeks when compared to a placebo, according to key secondary findings:
- Non-HDL-C: 53.0% decrease
- Apolipoprotein B (ApoB): 49.1% decrease
- 27.5% decrease in lipoprotein (a) (Lp(a))
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As early as week four, the LDL-C decreases were noted, and they persisted for a full year. A high adherence rate of 97% to the once-daily oral medicine was also noted in the trial.
According to Merck, the overall safety profile of enlicitide was identical to that of a placebo, with comparably low rates of adverse events and discontinuations. The business intends to provide results from this study and future CORALreef program studies to regulatory bodies across the globe.
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