- Opko Health (OPK +0.2%) completes enrollment in the pivotal Phase 3 clinical trial assessing its long-acting human growth hormone (hGH-CTP) in growth hormone deficient adults. The treatment period in the randomized, double-blind, placebo-controlled study is 26 weeks followed by a 26-week open-label extension.
- The primary endpoint is the change in trunk fat mass, expressed in kilograms, from baseline to week 26 versus placebo. The projected study completion date is June 2016. If successful, a regulatory submission will follow.
- The value proposition of hGH-CTP is the reduction of injections, from once daily to once weekly.