Alkermes plc ((ALKS)) announced an update on their ongoing clinical study.
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Alkermes plc is conducting a Phase 3 clinical study titled ‘ENLIGHTEN-Youth’ to evaluate weight gain in pediatric patients with schizophrenia or bipolar I disorder. The study aims to compare changes in BMI Z-score between treatments with OLZ/SAM, a combination of olanzapine and samidorphan, and olanzapine alone. This research is significant as it addresses weight management, a common side effect of antipsychotic treatments in young patients.
The interventions being tested are OLZ/SAM, a fixed-dose combination of olanzapine and samidorphan, and olanzapine. OLZ/SAM is designed to mitigate weight gain associated with olanzapine, a widely used antipsychotic medication.
The study is designed as a randomized, double-blind, parallel assignment with quadruple masking, involving participants, care providers, investigators, and outcomes assessors. The primary purpose of the study is treatment-focused, aiming to provide insights into effective weight management strategies for pediatric patients.
The study began on March 22, 2022, with an estimated completion date in 2025. The most recent update was submitted on October 8, 2025, indicating ongoing recruitment and data collection.
For investors, this study could influence Alkermes’ stock performance by potentially expanding its market share in pediatric antipsychotic treatments. The success of OLZ/SAM could differentiate Alkermes from competitors by offering a solution to a significant side effect of antipsychotic medications, potentially boosting investor confidence.
The study is ongoing, with further details available on the ClinicalTrials portal.