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

NCT05303064 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: ALKS 3831-A312
• Study Type: interventional
• Target: 220
• Locations: 5 countries
• Sites: 47

Brief Summary

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

Conditions

Bipolar I Disorder; Schizophrenia

Keywords

LYBALVI; Schizophrenia; Bipolar I Disorder; Pediatric; Olanzapine; Samidorphan

Outcome Measures

Primary Outcomes (1)

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

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

  12 weeks

Secondary Outcomes (7)

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

  12 weeks

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

  Up to 52 weeks

• Change from baseline in waist circumference

  12 weeks

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

  12 weeks

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

  12 weeks

Study Arms (2)

Group 1 OLZ/SAM

EXPERIMENTAL

Fixed dose combination of olanzapine and samidorphan

Drug: OLZ/SAM

Group 2 Olanzapine

ACTIVE COMPARATOR

Fixed dose of olanzapine

Drug: Olanzapine

Interventions

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.

Also known as: ALKS 3831, LYBALVI

Group 1 OLZ/SAM

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

Group 2 Olanzapine

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (47)

Alkermes Investigator Site

Dothan, Alabama, 36303, United States

RECRUITING

Alkermes Investigator Site

Little Rock, Arkansas, 72204, United States

RECRUITING

Alkermes Investigator Site

Encino, California, 91316, United States

WITHDRAWN

Alkermes Investigator Site

Stanford, California, 94305, United States

RECRUITING

Alkermes Investigator Site

Upland, California, 91786, United States

WITHDRAWN

Alkermes Investigator Site

Colorado Springs, Colorado, 80910, United States

WITHDRAWN

Alkermes Investigator Site

Denver, Colorado, 80202, United States

ACTIVE NOT RECRUITING

Alkermes Investigator Site

Hartford, Connecticut, 06106, United States

WITHDRAWN

Alkermes Investigator Site

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Alkermes Investigator Site

Miami, Florida, 33155, United States

WITHDRAWN

Alkermes Investigator Site

Miami Lakes, Florida, 33016, United States

RECRUITING

Alkermes Investigator Site

Decatur, Georgia, 30030, United States

RECRUITING

Alkermes Investigator Site

Chicago, Illinois, 60611, United States

RECRUITING

Alkermes Investigator Site

Indianapolis, Indiana, 46202, United States

RECRUITING

Alkermes Investigator Site

Saint Charles, Missouri, 63304, United States

RECRUITING

Alkermes Investigator Site

Lincoln, Nebraska, 68526, United States

RECRUITING

Alkermes Investigator Site

Omaha, Nebraska, 68198, United States

WITHDRAWN

Alkermes Investigator Site

Paramus, New Jersey, 07652, United States

WITHDRAWN

Alkermes Investigator Site

New York, New York, 10016, United States

RECRUITING

Alkermes Investigational Site

Kinston, North Carolina, 28504, United States

WITHDRAWN

Alkermes Investigator Site

Cincinnati, Ohio, 45219, United States

RECRUITING

Alkermes Investigator Site

West Chester, Ohio, 45069, United States

RECRUITING

Alkermes Investigator Site

DeSoto, Texas, 75115, United States

TERMINATED

Alkermes Investigator Site

Fort Worth, Texas, 76104, United States

WITHDRAWN

Alkermes Investigational Site

Richmond, Virginia, 23220, United States

RECRUITING

Alkermes Investigator Site

Everett, Washington, 98201, United States

RECRUITING

Alkermes Investigator Site

La Plata, Buenos Aires, 1900, Argentina

RECRUITING

Alkermes Investigator Site

La Plata, Buenos Aires, C1199ABB, Argentina

RECRUITING

Alkermes Investigator Site

Buenos Aires, C1133AAH, Argentina

RECRUITING

Alkermes Investigator Site

Córdoba, X5003DCE, Argentina

RECRUITING

Alkermes Investigator Site

Mendoza, 5500, Argentina

RECRUITING

Alkermes Investigator Site

Fortaleza, Ceará, 60430-140, Brazil

RECRUITING

Alkermes Investigator Site

Curitiba, Paraná, 80240-280, Brazil

RECRUITING

Alkermes Investigator Site

Goiânia, 74093-040, Brazil

RECRUITING

Alkermes Investigator Site

Rio de Janeiro, 22270-060, Brazil

RECRUITING

Alkermes Investigator Site

São Paulo, 01228-000, Brazil

RECRUITING

Alkermes Investigator Site

São Paulo, 05403-010, Brazil

RECRUITING

Alkermes Investigator Site

Barranquilla, 110121, Colombia

RECRUITING

Alkermes Investigator Site

Bello, 51053, Colombia

RECRUITING

Alkermes Investigator Site

Bogotá, 111166, Colombia

RECRUITING

Alkermes Investigator Site

Bogotá, 80020, Colombia

RECRUITING

Alkermes Investigator Site

Pereira, 660003, Colombia

RECRUITING

Alkermes Investigator Site

Culiacán, 80230, Mexico

RECRUITING

Alkermes Investigator Site

Estado de México, C.P. 07000, Mexico

RECRUITING

Alkermes Investigator Site

León, 37000, Mexico

RECRUITING

Alkermes Investigator Site

Monterrey, 64620, Mexico

RECRUITING

Alkermes Investigator Site

Monterrey, 64710, Mexico

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

lybalvi; Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David McDonnell, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Central Study Contacts

Global Clinical Services

CONTACT

888-235-8008 (US Only); clinicaltrials@alkermes.com

Global Clinical Services

CONTACT

1-571-599-2702 (Global); clinicaltrials@alkermes.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: June 30, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

US (26); ME (5); BR (6); AR (5); CO (5)