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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02694328
Enrollment
561
Registered
2016-02-29
Start date
2016-03-02
Completion date
2018-11-07
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Olanzapine, Weight

Brief summary

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

Interventions

DRUGALKS 3831

Daily dosing

DRUGOlanzapine

Daily dosing

Sponsors

Alkermes, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percent Change From Baseline in Body Weight at Week 24Baseline and Week 24
Percentage of Participants With >/= 10% Weight Gain at Week 24Baseline and Week 24

Secondary

MeasureTime frame
Percentage of Participants With >/= 7% Weight Gain at Week 24Baseline and Week 24
Number of Participants Experiencing of Adverse Events (AEs)24 weeks

Countries

Puerto Rico, United States

Participant flow

Participants by arm

ArmCount
Olanzapine
Administered as a coated bilayer tablet Olanzapine: Daily dosing
276
ALKS 3831
Administered as a coated bilayer tablet ALKS 3831: Daily dosing
274
Total550

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAbnormal Laboratory Value03
Overall StudyAdverse Event2733
Overall StudyIncarceration11
Overall StudyLack of Efficacy12
Overall StudyLost to Follow-up2622
Overall StudyNoncompliant with study drug118
Overall StudyPregnancy11
Overall StudyProtocol Violation65
Overall StudyWithdrawal by Subject2723

Baseline characteristics

CharacteristicOlanzapineTotalALKS 3831
Age, Continuous40.1 years
STANDARD_DEVIATION 10.01
40.2 years
STANDARD_DEVIATION 9.9
40.3 years
STANDARD_DEVIATION 9.79
Ethnicity (NIH/OMB)
Hispanic or Latino
42 Participants79 Participants37 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
234 Participants471 Participants237 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants4 Participants2 Participants
Race (NIH/OMB)
Asian
4 Participants8 Participants4 Participants
Race (NIH/OMB)
Black or African American
193 Participants392 Participants199 Participants
Race (NIH/OMB)
More than one race
8 Participants11 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants6 Participants2 Participants
Race (NIH/OMB)
White
65 Participants128 Participants63 Participants
Region of Enrollment
United States
276 participants550 participants274 participants
Sex: Female, Male
Female
69 Participants150 Participants81 Participants
Sex: Female, Male
Male
207 Participants400 Participants193 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2760 / 274
other
Total, other adverse events
159 / 276146 / 274
serious
Total, serious adverse events
7 / 27610 / 274

Outcome results

Primary

Percentage of Participants With >/= 10% Weight Gain at Week 24

Time frame: Baseline and Week 24

Population: The FAS population included all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment.

ArmMeasureValue (NUMBER)
OlanzapinePercentage of Participants With >/= 10% Weight Gain at Week 2429.8 Percentage of participants
ALKS 3831Percentage of Participants With >/= 10% Weight Gain at Week 2417.8 Percentage of participants
p-value: 0.00395% CI: [-22.8, -4.6]Regression, Logistic
Primary

Percent Change From Baseline in Body Weight at Week 24

Time frame: Baseline and Week 24

Population: The full analysis set (FAS) population includes all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
OlanzapinePercent Change From Baseline in Body Weight at Week 246.59 Percent change in body weightStandard Error 0.668
ALKS 3831Percent Change From Baseline in Body Weight at Week 244.21 Percent change in body weightStandard Error 0.681
p-value: 0.00395% CI: [-3.88, -0.88]ANCOVA
Secondary

Number of Participants Experiencing of Adverse Events (AEs)

Time frame: 24 weeks

Population: The Safety Population includes all randomized subjects who received at least 1 dose of study drug.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
OlanzapineNumber of Participants Experiencing of Adverse Events (AEs)227 Participants
ALKS 3831Number of Participants Experiencing of Adverse Events (AEs)203 Participants
Secondary

Percentage of Participants With >/= 7% Weight Gain at Week 24

Time frame: Baseline and Week 24

Population: The FAS population included all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment.

ArmMeasureValue (NUMBER)
OlanzapinePercentage of Participants With >/= 7% Weight Gain at Week 2442.7 Percentage of participants
ALKS 3831Percentage of Participants With >/= 7% Weight Gain at Week 2427.5 Percentage of participants
p-value: 0.00195% CI: [-25.3, -6.5]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026