A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)

Study Overview
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Brief Summary
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This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.

Official Title
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A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: ALKS 3831
* Drug: Olanzapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a body mass index (BMI) of 18.0-30.0 kg/m^2, inclusive, at Visit 1 and Visit 2 Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia Subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before Visit 1 Subject has maintained a stable body weight (change </= 5%) for at least 3 months prior to Visit 1 based on self-report Additional criteria may apply Exclusion Criteria: Subject has any of the following psychiatric conditions per DSM-5 criteria: Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current, untreated or unstable major depressive disorder Clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study Drug-induced or toxic psychosis Any other psychiatric condition that could interfere with participation in the study Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the investigator Subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder Additional criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS 3831<br>Administered as a coated bilayer tablet | Drug: ALKS 3831<br>* Daily dosing<br>|
| Active Comparator: Olanzapine<br>Administered as a coated bilayer tablet | Drug: Olanzapine<br>* Daily dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Body Weight at Week 24 |  | Baseline and Week 24 | 
| Percentage of Participants With >/= 10% Weight Gain at Week 24 |  | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With >/= 7% Weight Gain at Week 24 |  | Baseline and Week 24 | 
| Number of Participants Experiencing of Adverse Events (AEs) |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Olanzapine, Weight