Phase 3
Completed N=550
A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
Source: ClinicalTrials.gov NCT02694328 ↗Enrolled (actual)
550
Serious AEs
3.1%
Results posted
Feb 2020
Primary outcomePrimary: Percent Change From Baseline in Body Weight at Week 24 — 6.59; 4.21 Percent change in body weight — p=0.003
◆ Published Evidence
Established
24citations · ~8 / year
Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study.
Summary
This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.
Linked Publications (2)
-
Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study.
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Olanzapine/samidorphan combination consistently mitigates weight gain across various subgroups of patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Body Weight at Week 24 |
6.59; 4.21 | 0.003 sig |
| PRIMARY Percentage of Participants With >/= 10% Weight Gain at Week 24 |
29.8; 17.8 | 0.003 sig |
| SECONDARY Percentage of Participants With >/= 7% Weight Gain at Week 24 |
42.7; 27.5 | 0.001 sig |
| SECONDARY Number of Participants Experiencing of Adverse Events (AEs) |
227; 203 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02694328) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.