FDA Places Complete Clinical Hold on Zafgen’s Obesity Trial

Following the death of a second patient, the FDA has placed a complete clinical hold on Zafgen’s pivotal Phase 3 trial for beloranib, being studied for the treatment of Prader-Willi syndrome.

Zafgen CEO Thomas Hughes says the company is working to analyze the trial data to provide a clear view of the candidate’s safety and efficacy. Top-line results of the randomized portion of the trial are expected in the first quarter of 2016.

The most recent patient died after being diagnosed with bilateral pulmonary emboli. In October, a patient died from respiratory failure from pulmonary emboli.