Alkermes plc. initiated second of two core phase 3 studies for ALKS 3831, an investigational, novel, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia.
ENLIGHTEN-2 will evaluate the weight gain profile of ALKS 3831 in patients with schizophrenia over a six-month treatment period compared to olanzapine, an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities, including significant weight gain.
ALKS 3831 is designed to provide patients with the strong efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties.
ENLIGHTEN-2 is a multicenter, randomized, double-blind phase 3 study comparing weight gain of ALKS 3831 to olanzapine in approximately 540 patients with stable schizophrenia over six months. Safety and tolerability will also be evaluated in the study.
All participants in the double-blind portion of the study will be eligible to continue in an open-label safety study of ALKS 3831 for an additional 12 months. The objective of the extension phase of the study is to assess the safety and long-term tolerability of once-daily, oral ALKS 3831.
