Recruiting
Phase 3

Weight Gain

Sponsor:

Alkermes, Inc.

Code:

NCT05303064

Conditions

Schizophrenia

Bipolar I Disorder

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

OLZ/SAM

Olanzapine

Study Details

Brief summary:

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

Conditions

Schizophrenia

Bipolar I Disorder

Study ID

NCT05303064

Start date

Jun 30, 2022

Status verified date

Aug, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1 OLZ/SAM

Fixed dose combination of olanzapine and samidorphan

active comparator: Group 2 Olanzapine

Fixed dose of olanzapine

Interventions

OLZ/SAM

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.

Olanzapine

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 outcome measure

  • Change from baseline in body mass index (BMI) Zscore at week 12 [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Global Clinical Services

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

Global Clinical Services

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

Locations

Alkermes Investigator Site

Recruiting

Dothan, Alabama, United States, 36303

Alkermes Investigator Site

Recruiting

Little Rock, Arkansas, United States, 72204

Alkermes Investigator Site

Recruiting

Stanford, California, United States, 94305

Alkermes Investigator Site

Recruiting

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

Alkermes Investigator Site

Recruiting

Miami Lakes, Florida, United States, 33016

Alkermes Investigator Site

Recruiting

Decatur, Georgia, United States, 30030

Alkermes Investigator Site

Recruiting

Chicago, Illinois, United States, 60611

Alkermes Investigator Site

Recruiting

Indianapolis, Indiana, United States, 46202

Alkermes Investigator Site

Recruiting

Saint Charles, Missouri, United States, 63304

Alkermes Investigator Site

Recruiting

Lincoln, Nebraska, United States, 68526

Alkermes Investigator Site

Recruiting

New York, New York, United States, 10016

Alkermes Investigator Site

Recruiting

Cincinnati, Ohio, United States, 45219

Alkermes Investigator Site

Recruiting

West Chester, Ohio, United States, 45069

Alkermes Investigational Site

Recruiting

Richmond, Virginia, United States, 23220

Alkermes Investigator Site

Recruiting

Everett, Washington, United States, 98201

More Information

Sponsor

Alkermes, Inc.

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alkermes, Inc. on 2026-08-14.