- Newly released trial data from Eli Lilly's 12,000-patient study on its cholesterol drug evacetrapib showed no clinical benefit in reducing rates of heart attack, stroke, or cardiovascular disease, despite seemingly positive effects on lipid levels, the New York Times reports.
- Presented at the annual meeting of the American College of Cardiology, the data gave further insight into why Eli Lilly abruptly halted the phase 3 trial in October 2015. At the time, Lilly said there was a low probability the study's primary endpoint would be reached.
- Evacetrapib is one version of a class of cholesterol drugs known as CTEP inhibitors, which work by boosting the levels of HDL cholesterol, or "good" cholesterol. Two other CTEP inhibitors have failed while one, being developed by Merck, is still being studied.
While Lilly's announcement in October dashed hopes for evacetrapib, the newly announced full data only adds to the puzzle. The 12,000 patients studied were randomized and put into either a evacetrapib group or a placebo group. Average HDL levels of those on evacetrapib rose by about 130% while LDL, or "bad" cholesterol, levels fell by about 35%.
But these results did not translate into any meaningful clinical benefit. Rates of heart attack, stroke, and death from cardiovascular disease (CVD) were nearly identical in both groups, according to the New York Times.
CTEP inhibitors had generated a lot of excitement because of their potential to be an alternative to statins, a standard treatment for CVD. Some patients cannot tolerate statins, spurring the search for new and more effective treatment options.
Eli Lilly thought the drug could reach blockbuster status before its lack of efficacy brought the trial to a close. As the third failed CTEP inhibitor, evacetrapib's ineffectiveness on CVD may undermine development interest in the entire class.
Another new type of cholesterol drugs, known as PCSK9 inhibitors, are already on the market for the treatment of high cholesterol. However, their effect on CVD is still being studied.