GTx's Drug Improved Insulin Resistance Among Elderly Patients
GTx announced that data from a recently conducted Phase II clinical trial of Ostarine in 60 elderly men and 60 postmenopausal women revealed that insulin and glucose levels were reduced and insulin resistance was improved among subjects receiving the 3-mg dose of Ostarine compared with baseline. These observations were even more pronounced among a subset of prediabetic subjects.
In the three-month Phase II clinical trial in which patients with diabetes or obesity were excluded, subjects treated with Ostarine 3 mg had on average an 11 percent decline in fasting blood glucose levels, a 17.6 percent reduction in insulin levels and a 26.8 percent reduction in insulin resistance compared with their baseline measurements. Improvements in insulin resistance were more apparent among a small subset of prediabetic patients treated with Ostarine 3 mg in whom the mean fasting blood glucose level declined by 17.4 percent, insulin levels reduced by 29.4 percent and insulin resistance decreased by 41.3 percent.
Improvements in insulin resistance among subjects receiving the 3-mg dose provide additional supporting evidence of the anabolic activity of Ostarine, the company said. The resulting changes in body composition (increased muscle and decreased fat) with Ostarine treatment appear to have a beneficial impact on insulin resistance. These data compare favorably to results of clinical trials using FDA-approved diabetic drugs in a prediabetic population. For example, in a one-year study, prediabetic patients taking rosiglitazone 8 mg evidenced a decline in fasting blood glucose levels of 9 percent from their baseline measurements, the company noted.
"These data suggest Ostarine may have a beneficial impact on prediabetic conditions and potentially diabetes, which, if validated in later studies, could provide the basis for our seeking expanded indications for Ostarine," Ronald Morton, chief medical officer of GTx, said.
In addition, the company is planning to initiate a Phase IIb clinical trial evaluating Ostarine for the treatment of chronic kidney disease muscle wasting by the end of the year.