SchizophreniaPhase 3NCT05303064
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
A Phase 3 study testing OLZ/SAM and Olanzapine in people with Schizophrenia and Bipolar I Disorder, run by Alkermes, Inc. at 47 sites in 5 countries.
Trial summary
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Schizophrenia, Bipolar I Disorder
- What is being tested?
- OLZ/SAM and Olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 47 sitesin 5 countries
- Study dates
- 30 Jun 2022to Sep 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
47 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
47 sites in 5 countries
United States26 sites, 15 recruiting
- Recruiting
Alkermes Investigator Site
Chicago, Illinois, 60611
- Recruiting
Alkermes Investigator Site
Cincinnati, Ohio, 45219
- Withdrawn
Alkermes Investigator Site
Colorado Springs, Colorado, 80910
- Recruiting
Alkermes Investigator Site
Decatur, Georgia, 30030
- Active, not recruiting
Alkermes Investigator Site
Denver, Colorado, 80202
- Terminated
Alkermes Investigator Site
DeSoto, Texas, 75115
- Recruiting
Alkermes Investigator Site
Dothan, Alabama, 36303
- Withdrawn
Alkermes Investigator Site
Encino, California, 91316
- Recruiting
Alkermes Investigator Site
Everett, Washington, 98201
- Withdrawn
Alkermes Investigator Site
Fort Worth, Texas, 76104
- Withdrawn
Alkermes Investigator Site
Hartford, Connecticut, 06106
- Recruiting
Alkermes Investigator Site
Indianapolis, Indiana, 46202
- Withdrawn
Alkermes Investigational Site
Kinston, North Carolina, 28504
- Recruiting
Alkermes Investigator Site
Lincoln, Nebraska, 68526
- Recruiting
Alkermes Investigator Site
Little Rock, Arkansas, 72204
- Withdrawn
Alkermes Investigator Site
Miami, Florida, 33155
- Recruiting
Alkermes Investigator Site
Miami Lakes, Florida, 33016
- Recruiting
Alkermes Investigator Site
New York, New York, 10016
- Withdrawn
Alkermes Investigator Site
Omaha, Nebraska, 68198
- Withdrawn
Alkermes Investigator Site
Paramus, New Jersey, 07652
- Recruiting
Alkermes Investigational Site
Richmond, Virginia, 23220
- Recruiting
Alkermes Investigator Site
Saint Charles, Missouri, 63304
- Recruiting
Alkermes Investigator Site
Stanford, California, 94305
- Withdrawn
Alkermes Investigator Site
Upland, California, 91786
- Recruiting
Alkermes Investigator Site
Washington D.C., District of Columbia, 20010
- Recruiting
Alkermes Investigator Site
West Chester, Ohio, 45069
Brazil6 sites, 6 recruiting
- Recruiting
Alkermes Investigator Site
Curitiba, Paraná, 80240-280
- Recruiting
Alkermes Investigator Site
Fortaleza, Ceará, 60430-140
- Recruiting
Alkermes Investigator Site
Goiânia, 74093-040
- Recruiting
Alkermes Investigator Site
Rio de Janeiro, 22270-060
- Recruiting
Alkermes Investigator Site
São Paulo, 01228-000
- Recruiting
Alkermes Investigator Site
São Paulo, 05403-010
Argentina5 sites, 5 recruiting
- Recruiting
Alkermes Investigator Site
Buenos Aires, C1133AAH
- Recruiting
Alkermes Investigator Site
Córdoba, X5003DCE
- Recruiting
Alkermes Investigator Site
La Plata, Buenos Aires, 1900
- Recruiting
Alkermes Investigator Site
La Plata, Buenos Aires, C1199ABB
- Recruiting
Alkermes Investigator Site
Mendoza, 5500
Colombia5 sites, 4 recruiting
- Recruiting
Alkermes Investigator Site
Barranquilla, 110121
- Recruiting
Alkermes Investigator Site
Bello, 51053
- Active, not recruiting
Alkermes Investigator Site
Bogotá, 111166
- Recruiting
Alkermes Investigator Site
Bogotá, 80020
- Recruiting
Alkermes Investigator Site
Pereira, 660003
Mexico5 sites, 5 recruiting
- Recruiting
Alkermes Investigator Site
Culiacán, 80230
- Recruiting
Alkermes Investigator Site
Estado de México, C.P. 07000
- Recruiting
Alkermes Investigator Site
León, 37000
- Recruiting
Alkermes Investigator Site
Monterrey, 64620
- Recruiting
Alkermes Investigator Site
Monterrey, 64710
About this study
Official 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)
To compare changes in body mass index (BMI) Z-score following treatment with OLZ/SAM vs olanzapine
- Conditions
- Schizophrenia, Bipolar I Disorder
- Being tested
- OLZ/SAM, Olanzapine
- Keywords
- LYBALVI, Schizophrenia, Bipolar I Disorder, Pediatric, Olanzapine, Samidorphan
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLZ/SAMDrug
Also called ALKS 3831, LYBALVI
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.
OlanzapineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 OLZ/SAM | Experimental | Fixed dose combination of olanzapine and samidorphan Receives: Drug: OLZ/SAM |
| Group 2 Olanzapine | Active comparator | Fixed dose of olanzapine Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (7)
Proportion of subjects with >=0.5 increase in BMI Z-score at Week 12
To compare subjects with clinical significant BMI Z-score increase with OLZ/SAM vs olanzapine
Measured: 12 weeks
Time to all-cause discontinuation of study drug over 52 weeks
To compare time to all-cause discontinuation of study drug with OLZ/SAM vs olanzapine
Measured: Up to 52 weeks
Change from baseline in waist circumference
To compare the change from baseline in waist circumference with OLZ/SAM vs olanzapine
Measured: 12 weeks
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score for patients with schizophrenia by visit
To compare the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score with OLZ/SAM vs olanzapine for patients with schizophrenia
Measured: 12 weeks
Change from baseline in Young Mania Rating Scale (YMRS) in patients with Bipolar I disorder
To compare the change from baseline in YMRS with OLZ/SAM vs olanzapine for patients with bipolar I disorder
Measured: 12 weeks
Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) for patients with bipolar I disorder by visit
To compare the change from baseline in CDRS-R with OLZ/SAM vs olanzapine for patients with bipolar I disorder
Measured: 12 weeks
Incidence of Adverse Events
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start30 Jun 2022
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David McDonnell, MD, Study director, Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303064
- Sponsor's protocol ID
- ALKS 3831-A312
- Status last verified
- Aug 2026
- First submitted
- 22 Mar 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided