Oral pill cuts bad cholesterol by 60% in phase 2 clinical trial
High cholesterol levels are a common and potentially deadly health problem, but a new drug could help more people manage the condition. An experimental pill has been shown to reduce levels of “bad” cholesterol by 60% in a phase 2 clinical trial.
Known as MK-0616, the new drug works by inhibiting a protein called PCSK9, lower levels of which helps the liver break down low-density lipoprotein (LDL) cholesterol. PCSK9 inhibitors have been a major avenue for treatments to reduce cholesterol, but it usually involves subcutaneous injections, or in one study even gene therapy.
The new trial investigated the efficacy of MK-0616 as an oral PCSK9 inhibitor. Over 380 participants enrolled, who all had elevated levels of LDL cholesterol and a history of heart disease or risk factors for it. They were randomly assigned to one of five groups, receiving either a placebo or MK-0616 at four different doses – 6 mg, 12 mg, 18 mg or 30 mg. Participants took the medication daily for eight weeks then stopped, while researchers measured their LDL cholesterol levels before and after the trial period, then continued monitoring for adverse effects for a further eight weeks.
Sure enough, participants taking any dosage of the drug saw significant drops in their LDL cholesterol levels compared to placebo. Those receiving doses of 30 mg saw drops of over 60%, 18 mg dropped 59%, 12 mg dropped 55% and 6 mg dropped 41%. Other biomarkers of bad cholesterol, including non-HDL cholesterol and a protein called ApoB, were also reduced. Importantly, the team saw no evidence of adverse side effects at any dose.
While further trials will be needed to investigate MK-0616 in more detail, the team says the drug is a promising new addition to the arsenal in cardiovascular care. It works well in conjunction with statins, the first-line therapy for high cholesterol, as 60% of participants were taking them during the trial. Being an oral pill, the drug could make it easier for patients to stick to, as well as reducing costs.
“This is a highly effective compound that was well tolerated," said Christie Ballantyne, lead author of the study. “MK-0616 could offer another potential option. Between this and statins and the other therapies we have, we should be able to basically treat almost everybody in terms of LDL cholesterol.”
A phase 3 clinical trial is currently being planned. The research was published in the Journal of the American College of Cardiology.
Source: American College of Cardiology