Phase III aleglitazar trial stopped due to safety concerns
Roche has halted the aleglitazar AleCardio phase III trial following the results of a safety review . The independent Data and Safety Monitoring Board has recommended to halt the trial due to safety signals and lack of efficacy. Roche has announced to stop the AleCardio trial and all other trials involving aleglitazar.
The AleCardio trial evaluated the efficacy and safety of aleglitazar in patients with a recent acute coronary syndrome event and type 2 diabetes. Data obtained in the trial thus far will be further analysed to better understand the current findings and will be made available at a future medical meeting.
Roche is working with investigators to support the management of patients for a safe transition from aleglitazar treatment to other blood sugar control therapies.