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news.Essentialis, a US-based pharmaceutical firm, has dosed the first patient in clinical trial (PC025), to assess the safety and efficacy of diazoxide choline controlled release tablets (DCCR) in obese Prader-Willi syndrome (PWS) patients.
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The single-center, randomized withdrawal trial will enrol about 12 PWS patients between 10 and 20 years old.
During the trial, patients will be titrated through five doses of DCCR over ten weeks of open label treatment followed by a four week double-blind, placebo-controlled, randomized withdrawal phase during which half of the patients will be randomized to continue on DCCR and half will be randomized to placebo.
Endpoints of the trial include safety measures, and changes in hyperphagia, weight, fat mass and resting energy expenditure.
According to the company, these endpoints will be measured both during the open label titration phase and the double-blind, placebo-controlled, randomized withdrawal phase.
The company said that open label data from this trial is available effective immediately and the double-blind, placebo-controlled results are expected to be released in the fourth quarter of 2014.