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NCT03187769 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder
A Phase 3 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 3
- Development phase
- 426
- Enrollment target
NCT03187769: Completed Phase 3 study, sponsored by Alkermes.
NCT03187769 is a Phase 3 study that has completed, run by Alkermes. The registered enrollment target is 426 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03187769, a Phase 3 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 426 participants
- Enrollment target
Study Summary
This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness
Primary Outcome
The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug
Interventions
- DRUG Olanzapine
- DRUG ALKS 3831
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 426 participants |
| Start Date | 2017-06-08 |
| Est. Completion | 2022-01-03 |
| Phase | Phase 3 |
What the finished NCT03187769 record still lists
NCT03187769 is an interventional study that assigns participants to a tested intervention. The registered 426 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Olanzapine is the first listed.
NCT03187769 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03187769 about?
NCT03187769 is a clinical study titled "Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder". This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness
What is the current status of trial NCT03187769?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 426 participants. The study started on 2017-06-08. Estimated completion is 2022-01-03.
What interventions are being tested in trial NCT03187769?
The interventions under investigation include: Olanzapine (DRUG), ALKS 3831 (DRUG).
Who is sponsoring clinical trial NCT03187769?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03187769's enrollment target sits among peer trials
426 882nd of 2000 higher than 1,118 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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