The phase 1, multicenter, randomized, double-blind, placebo- and active-controlled study was designed to compare the mean change from baseline in body weight following three weeks of oral administration of ALKS 3831 in a study that included 106 healthy, normal-weight male volunteers. The safety and tolerability results for ALKS 3831 were overall similar to those observed with the olanzapine-only treatment group. Healthy volunteers who received ALKS 3831 gained an average of 2.5 kg (5.5 lbs), while subjects who received olanzapine alone gained an average of 3.4 kg. The difference between the ALKS 3831 treatment group and the control group receiving olanzapine alone was statistically significant over the three-week study period, with a trend indicating the potential for even greater differentiation over longer study periods.
Based on the positive results of the phase 1 study, Alkermes plans to initiate a phase 2 dose-ranging study of ALKS 3831 in mid calendar 2013.
Recent ALKS News
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