Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
← catalyst calendarNCT05303064 · readout ≤ 42 d
Sponsored by Alkermes, Inc. (industry) · ALKS — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
220estimated
Sites
47
Countries
Argentina, Brazil, Colombia +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-06-30 | actual | When the study began enrolling |
| Primary completion | Sep 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2022-03-31 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Schizophrenia
- Bipolar I Disorder
Interventions
- Drug: OLZ/SAM — also filed as ALKS 3831, LYBALVI
- Drug: Olanzapine
Primary outcome
what the primary-completion date above is the date OFChange from baseline in body mass index (BMI) Zscore at week 12
measured 12 weeks
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