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Evaluating weight gain in children with schizophrenia or bipolar disorder

A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ/SAM vs Olanzapine to Evaluate Weight Gain as Assessed by Change in BMI Z-Score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)

PHASE3 · Alkermes, Inc. · NCT05303064

This study is testing if a new treatment can help children with schizophrenia or bipolar disorder manage weight gain caused by their current medication.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment220 (estimated)
Ages10 Years to 17 Years
SexAll
SponsorAlkermes, Inc. (industry)
Locations47 sites (Dothan, Alabama and 46 other locations)
Trial IDNCT05303064 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the changes in body mass index (BMI) Z-score in pediatric patients diagnosed with schizophrenia or bipolar I disorder after treatment with OLZ/SAM versus olanzapine. The study will include participants aged 10 to 17 years who have been diagnosed according to DSM-5 criteria and are currently receiving treatment for their condition. The trial will assess the effectiveness of the new treatment in managing weight gain, which is a common side effect of antipsychotic medications. Participants will be monitored on an outpatient basis with the support of their family or legal guardians.

Who should consider this trial

Good fit: Ideal candidates for this study are children and adolescents aged 10 to 17 years diagnosed with schizophrenia or bipolar I disorder who have had inadequate responses to current antipsychotic treatments.

Not a fit: Patients with major depressive episodes or other neuropsychiatric diagnoses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer treatment option that minimizes weight gain for pediatric patients with schizophrenia or bipolar disorder.

How similar studies have performed: Other studies have shown varying success with similar approaches, but this specific combination of treatments is being evaluated for the first time in this population.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Subjects aged 13 to 17 years with schizophrenia or aged 10 to 17 years with bipolar I disorder, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
* Subject is an outpatient or will be able to be treated on an outpatient basis (per Investigator judgement) by study Week 2
* Subject has reliable family/legal guardian support available for outpatient management
* Subject is either currently treated with olanzapine, or if treated with another antipsychotic, the subject has had an inadequate response (eg, unsatisfactory clinical response, AEs, or nonadherence to current medication) based on Investigator judgment
* Subject must not be a danger to self or others (per Investigator judgement)

Exclusion Criteria:

* Subject presents with a major depressive episode(bipolar I disorder) or other neuropsychiatric diagnosis (according to DSM-5 criteria) including schizoaffective disorder, current major depressive disorder that is untreated and/or unstable, or any other psychiatric condition that could interfere with participation in the study
* Subject has a history of seizure disorder (exception: history of febrile seizures), severe head trauma with loss of consciousness within the 12 months prior to Screening, or other clinically significant neurological condition within the 12 months prior to Screening
* Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale (C-SSRS)
* Subject has received olanzapine for \>= 14 days during the month prior to screening, or has a history of poor or inadequate response to treatment with olanzapine
* Subject has taken opioid agonists within 14 days prior to Screening, or within 30 days prior to Screening (for long-acting opioid agonists)
* Subject anticipates needing to take opioid medication during the study period (eg, planned surgery, including oral surgery)
* Subject has taken opioid antagonists including naltrexone (any formulation) or naloxone within 60 days prior to Screening
* Subject has used a long-acting injectable antipsychotic medication within 3 injection cycles prior to Screening
* Subject has a BMI percentile \>98th or \<5th
* Subject has a diagnosis of diabetes mellitus or presents with prediabetes lab results at Screening (hemoglobin A1c \[HbA1c\] \>= 6%)
* Subject has started a smoking cessation program within the 6 months prior to Screening or has joined a weight management program or has had significant changes in diet or exercise regimen within 6 weeks prior to Screening
* Subject has participated in a clinical study of an investigational product within the last 30 days prior to Screening

Where this trial is running

Dothan, Alabama and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Schizophrenia, Bipolar I Disorder, LYBALVI, Pediatric, Olanzapine, Samidorphan

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.