OPKO Health, Inc. has completed enrollment in the single pivotal Phase 3 trial of its long acting human growth hormone (hGH-CTP) in growth hormone deficient (GHD) adults.
The trial is designed to evaluate the safety and efficacy of hGH-CTP with a primary endpoint of superiority compared to placebo in decreasing fat mass in adults with GHD. The trial is a randomized, double-blind, placebo-controlled, multi-center, global study in adults with GHD. The study is divided into two treatment periods: a 26-week, double-blind, placebo-controlled period, followed by a 26-week, open-label extension. For further detail on the Phase 3 study, visit https://clinicaltrials.gov/ct2/show/NCT01909479.
The study is expected to end toward the second half of 2016; regulatory submission will follow study completion.