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NCT Number: NCT05303064

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alkermes Investigator Site, La Plata, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OLZ/SAM

Drug

OLZ/SAM refers to the fixed dose combination of olanzapine and samidorphan. The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day. The starting dose of samidorphan will be 5 or 10 mg.

Other names: ALKS 3831, LYBALVI

Olanzapine

Drug

The starting dose of olanzapine will be 2.5 mg/day or 5 mg/day at the discretion of the Investigator with a maximum daily dose of 20mg/day

Primary outcomes

  1. Change from baseline in body mass index (BMI) Zscore at week 12

    Time frame: 12 weeks

    To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine

Secondary outcomes

  1. Proportion of subjects with >=0.5 increase in BMI Z-score at Week 12

    Time frame: 12 weeks

    To compare subjects with clinical significant BMI Z-score increase with OLZ/SAM vs olanzapine

  2. Time to all-cause discontinuation of study drug over 52 weeks

    Time frame: Up to 52 weeks

    To compare time to all-cause discontinuation of study drug with OLZ/SAM vs olanzapine

  3. Change from baseline in waist circumference

    Time frame: 12 weeks

    To compare the change from baseline in waist circumference with OLZ/SAM vs olanzapine

  4. Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score for patients with schizophrenia by visit

    Time frame: 12 weeks

    To compare the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score with OLZ/SAM vs olanzapine for patients with schizophrenia

  5. Change from baseline in Young Mania Rating Scale (YMRS) in patients with Bipolar I disorder

    Time frame: 12 weeks

    To compare the change from baseline in YMRS with OLZ/SAM vs olanzapine for patients with bipolar I disorder

  6. Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) for patients with bipolar I disorder by visit

    Time frame: 12 weeks

    To compare the change from baseline in CDRS-R with OLZ/SAM vs olanzapine for patients with bipolar I disorder

  7. Incidence of Adverse Events

    Time frame: Up to 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Global Clinical Services

CONTACT

[email protected]

888-235-8008 (US Only)

Global Clinical Services

CONTACT

[email protected]

1-571-599-2702 (Global)

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2022
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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