Roche has announced that it has stopped the Phase III dal-OUTCOMES trial of the cholesteryl ester transfer protein (CETP) inhibitor dalcetrapib.
The Data and Safety Monitoring Board recommended stopping the trial due to a “lack of clinically meaningful efficacy.”
The dal-OUTCOMES trial evaluated the efficacy and safety profile of dalcetrapib when added to existing standard of care in patients with stable coronary heart disease following an acute coronary syndrome (ACS).
Approximately 15,600 patients were randomly assigned to receive daily doses of dalcetrapib 600 mg or matching placebo, beginning 4 to 12 weeks after their index ACS event.
There were no pre-specified boundaries for high-density lipoprotein cholesterol levels at entry. Other elements of care, including management of low-density lipoprotein cholesterol, were to follow best evidence-based practice.
The primary efficacy measure was time to first occurrence of coronary heart disease death, nonfatal acute myocardial infarction, unstable angina requiring hospital admission, resuscitated cardiac arrest, or atherothrombotic stroke.
The researchers hoped that dalcetrapib would be a CETP inhibitor that succeeded where torcetrapib failed.
“Lowering cardiovascular risk beyond that which is achieved with intensive statin treatment is a very challenging goal and while we have always stated that dalcetrapib is a high-risk project, we are disappointed by the fact that this drug didn’t provide benefit to the patients in our study,” commented Hal Barron, Chief Medical Officer of Roche.
“We continue to be fully committed to the development of innovative medicines for people with cardiovascular disease. Our pipeline remains robust with 23 positive late-stage clinical trials reporting over the past 16 months and a significant increase in New Molecular Entities in late-stage development.”
Roche has also decided to terminate all studies in the dal-HEART program—a global development program involving six clinical trials: dal-OUTCOMES, dal-OUTCOMES 2, dal-PLAQUE 2, dal-ACUTE, dal-PLAQUE (completed), and dal-VESSEL (completed).
By Nikki Withers