Under construction – not a live service
Sign in
Taking people in ArgentinaPhase 3

Compares weight change of two drugs in youths with schizophrenia or bipolar I disorder

Compares weight changes from OLZ/SAM and olanzapine in children with schizophrenia or bipolar I.

Key facts

Who runs it
Alkermes, Inc.
Where
Buenos Aires, Córdoba, La Plata, and Mendoza, ArgentinaSee the 4 sitesAlso in 4 other countries, 39 sites
Trial code
Registry title
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Status
Recruiting
Phase
Phase 3
People taking part
220 people, planned
Started
30 Jun 2022
Planned end
Sept 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • OLZ/SAM
  • Olanzapine
Record updated
14 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with schizophrenia or bipolar I disorder who can be treated as outpatients. It compares OLZ/SAM with olanzapine and checks weight gain.

Age
13 to 17 years with schizophrenia; 10 to 17 years with bipolar I disorder.
Sex
All sexes can join.
Disease stage
Schizophrenia or bipolar I disorder, diagnosed by DSM-5 criteria. The person must be treatable as an outpatient and must not be a danger to self or others.
Earlier treatment
The person is now treated with olanzapine, or had an inadequate response to another antipsychotic. Olanzapine for 14 days or more in the month before screening is not allowed.

Main reasons for not taking part

  • Major depressive episode or other psychiatric diagnosis, such as schizoaffective disorder
  • Seizure disorder or other significant neurological condition
  • Current suicide risk
  • Diabetes, or HbA1c of 6% (42 mmol/mol) or more
  • BMI percentile above the 98th or below the 5th

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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 take part

  • 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 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 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
  • 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 diagnosis of diabetes mellitus or presents with prediabetes lab results at Screening (hemoglobin A1c [HbA1c] >= 6%)
  • 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 a BMI percentile >98th or <5th

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 10 and 17 years old?

Where in Argentina

Also in 4 other countries, 39 sites

  • Buenos AiresHospital not named in the registryContact: Global Clinical ServicesTaking people
  • CórdobaHospital not named in the registryContact: Global Clinical ServicesTaking people
  • La Plata, Buenos AiresHospital not named in the registryContact: Global Clinical ServicesTaking people
  • MendozaHospital not named in the registryContact: Global Clinical ServicesTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Group 1 OLZ/SAMTreatment being tested

    Fixed dose combination of olanzapine and samidorphan

    Treatment: OLZ/SAM

  • Group 2 OlanzapineExisting treatment, for comparison

    Fixed dose of olanzapine

    Treatment: Olanzapine

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Compares weight change of two drugs in youths with schizophrenia or bipolar I disorderGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05303064, who can take part
Record updated
14 August 2026