Clinical Trials
In December 2006, GTx completed a 3 month Phase II double-blind, randomized, placebo-controlled clinical trial in 120 subjects (60 elderly men and 60 postmenopausal women). Enobosarm treatment resulted in a dose-dependent increase in lean body mass (LBM), with those taking the highest dose of 3mg per day showing an average LBM increase of 1.4 kg (3.1 lbs) compared to those who received placebo. The Enobosarm treatment also resulted in improvement in muscle function (performance) in a 12 stair climb test measuring speed and power. Enobosarm had a favorable safety profile, with no serious adverse events reported. Enobosarm also exhibited tissue selectivity with beneficial effects on lean body mass and performance and with no apparent change in measurements of serum PSA, sebum production or serum LH.
In October 2008, GTx announced topline results of the Phase II trial evaluating Enobosarm in patients with cancer cachexia. The clinical trial enrolled 159 cancer patients (average age of 66 years) with non-small cell lung cancer, colorectal cancer, non-Hodgkin lymphoma, chronic lymphocytic leukemia or breast cancer at 35 sites in the U.S. and Argentina. Participants were randomized to receive placebo, 1mg or 3mg oral capsule of Enobosarm once daily for 16 weeks. Average reported weight loss prior to entry among all subjects was 8.8%. Subjects were allowed to have standard chemotherapy during the trial. The study met its primary endpoint of absolute change in total lean body mass (muscle) compared to placebo and the secondary endpoint of muscle function (performance). The incidence of serious adverse events, deaths and tumor progression were similar among placebo and the treatment arms. The most common side effects reported among all subjects in the trial were fatigue, anemia, nausea and diarrhea.
GTx and Merck had clinical development plans to evaluate Enobosarm for the treatment of muscle loss in patients with COPD and for the treatment of chronic sarcopenia. They had a goal of initiating an Enobosarm Phase II COPD clinical trial in the first quarter of 2010 and an Enobosarm Phase IIb chronic sarcopenia clinical trial in 2010.
In June 2013, professional cyclist Nikita Novikov was provisionally suspended after a possible breach of anti-doping rules, due to a positive A-sample result for Ostarine.
Read more about this topic: Ostarine
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