Source: OPKO Health Inc. & reported by https://globenewswire.com/
MIAMI, Dec. 30, 2016 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) announced it has commenced data analysis in the phase 3, double-blind, placebo-controlled study of its investigational long-acting human growth hormone product (hGH-CTP) in adults with growth hormone deficiency (GHD). The multinational, multi-center study, which utilized a 2:1 randomization between hGH-CTP and placebo, enrolled 203 subjects, 198 of whom received at least one dose of study treatment. Treatment was administered through a weekly injection.
On the primary endpoint of change in trunk fat mass from baseline to 26 weeks, there was no statistical difference between hGH-CTP and placebo. However, after unblinding the study, OPKO identified one or more outliers that may have affected the primary outcome. As a result, OPKO is undertaking further review of the study population as promptly as possible. The safety profile observed in this study was consistent with that known for growth hormone treatments. A greater percentage of subjects on hGH-CTP normalized serum concentrations of insulin-like growth factor-I compared to placebo. Additional efficacy and safety data and analyses from the study will be released once available.
Read more: https://globenewswire.com/news-release/2016/12/30/902328/0/en/OPKO-Health-Provides-Update-on-hGH-CTP-Clinical-Programs.html