SchizophreniaPhase 3NCT02694328

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

A Phase 3 study testing ALKS 3831 and Olanzapine in people with Schizophrenia, run by Alkermes, Inc. at 54 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Schizophrenia
What is being tested?: ALKS 3831 and Olanzapine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 561 participants
Where: 54 sitesin 2 countries
Study dates: 2 Mar 2016to 7 Nov 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

54 sites in 2 countries.

Country

City, postcode or hospital

54 sites in 2 countries

United States52 sites

Alkermes Investigational Site
Allentown, Pennsylvania, 18104
Alkermes Investigational Site
Anaheim, California, 92805
Alkermes Investigational Site
Atlanta, Georgia, 30329
Alkermes Investigational Site
Augusta, Georgia, 30912
Alkermes Investigational Site
Austin, Texas, 78754
Alkermes Investigational Site
Austin, Texas, 78759
Alkermes Investigational Site
Bellevue, Washington, 98007
Alkermes Investigational Site
Berlin, New Jersey, 08009
Alkermes Investigational Site
Brooklyn, New York, 11235
Alkermes Investigational Site
Canton, Ohio, 44718
Alkermes Investigational Site
Cerritos, California, 90703
Alkermes Investigational Site
Chicago, Illinois, 60640
Alkermes Investigational Site
Creve Coeur, Missouri, 63141
Alkermes Investigational Site
Culver City, California, 90230
Alkermes Investigational Site
Dallas, Texas, 75243
Alkermes Investigational Site
Dayton, Ohio, 45417
Alkermes Investigational Site
Decatur, Georgia, 30030
Alkermes Investigational Site
DeSoto, Texas, 75115
Alkermes Investigational Site
Flowood, Mississippi, 39232
Alkermes Investigational Site
Garden Grove, California, 92845
Alkermes Investigational Site
Glendale, California, 91206
Alkermes Investigational Site
Grand Rapids, Michigan, 49503
Alkermes Investigational Site
Houston, Texas, 77030
Alkermes Investigational Site
Jamaica, New York, 11432
Alkermes Investigational Site
Las Vegas, Nevada, 89102
Alkermes Investigational Site
Lauderhill, Florida, 33319
Alkermes Investigational Site
Little Rock, Arkansas, 72211
Alkermes Investigational Site
Long Beach, California, 90822
Alkermes Investigational Site
Marlton, New Jersey, 08053
Alkermes Investigational Site
Miami, Florida, 33136
Alkermes Investigational Site
Middleburg Heights, Ohio, 44130
Alkermes Investigational Site
National City, California, 91950
Alkermes Investigational Site
New York, New York, 10032
Alkermes Investigational Site
New York, New York, 10035
Alkermes Investigational Site
North Miami, Florida, 33161
Alkermes Investigational Site
O'Fallon, Missouri, 63368
Alkermes Investigational Site
Oakland, California, 94612
Alkermes Investigational Site
Oakland Park, Florida, 33334
Alkermes Investigational Site
Oceanside, California, 92056
Alkermes Investigational Site
Orange, California, 92868
Alkermes Investigational Site
Pico Rivera, California, 90660
Alkermes Investigational Site
Redlands, California, 92374
Alkermes Investigational Site
Rochester, New York, 14615
Alkermes Investigational Site
San Diego, California, 92103
Alkermes Investigational Site
San Diego, California, 92123
Alkermes Investigational Site
Springdale, Arkansas, 72764
Alkermes Investigational Site
St Louis, Missouri, 63128
Alkermes Investigational Site
Tampa, Florida, 33609
Alkermes Investigational Site
Temecula, California, 92591
Alkermes Investigational Site
Torrance, California, 90502
Alkermes Investigational Site
Wards Island, New York, 10035
Alkermes Investigational Site
Washington D.C., District of Columbia, 20016

Other trials in United States

Puerto Rico2 sites

Alkermes Investigational Site
San Juan, PR, 00918
Alkermes Investigational Site
San Juan, PR, 00926

Other trials in Puerto Rico

About this study

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

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

Conditions: Schizophrenia
Being tested: ALKS 3831, Olanzapine
Keywords: Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Olanzapine, Weight
Medical subject headings: Schizophrenia, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALKS 3831Drug
Daily dosing
OlanzapineDrug
Daily dosing

Study groups in NCT02694328
Study group	Role	What they receive
ALKS 3831	Experimental	Administered as a coated bilayer tablet Receives: Drug: ALKS 3831
Olanzapine	Active comparator	Administered as a coated bilayer tablet Receives: Drug: Olanzapine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 20167 Nov 2018

First posted29 Feb 2016 (estimated)
Study start2 Mar 2016
Primary completion7 Nov 2018
Study completion7 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 561 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02694328
Sponsor's protocol ID: ALK3831-A303
Status last verified: Jan 2020
First submitted: 24 Feb 2016
Last updated: 10 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Correll CU, Stein E, Graham C, DiPetrillo L, Akerman S, Stanford AD, Jiang Y, Yagoda S, McDonnell D, Hopkinson C. Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study. Schizophr Bull. 2023 Mar 15;49(2):454-463. doi: 10.1093/schbul/sbac144.
PubMed 36305696
Meyer JM, Simmons A, Jiang Y, Graham C, Yagoda S, McDonnell D. Olanzapine/samidorphan combination consistently mitigates weight gain across various subgroups of patients. CNS Spectr. 2023 Aug;28(4):478-481. doi: 10.1017/S1092852922000967. Epub 2022 Oct 13.
PubMed 36226902

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Study to Evaluate Weight Gain of ALKS 3831 Compared to Olanzapine in Adults With Schizophrenia
ClinicalTrials.gov ID: NCT02694328
Acronym / sponsor ID: ALK3831-A303
Conditions: Schizophrenia
Keywords: Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Olanzapine, Weight
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 561 participants (actual)
Lead sponsor: Alkermes, Inc.Industry (pharma, biotech, devices)
Study start: 2 Mar 2016 (actual)
Primary completion: 7 Nov 2018 (actual)
Study completion: 7 Nov 2018 (actual)
First posted: 29 Feb 2016 (estimated)
Results: Posted 10 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ALKS 3831	Experimental	Drug: ALKS 3831Administered as a coated bilayer tablet
Olanzapine	Active comparator	Drug: OlanzapineAdministered as a coated bilayer tablet

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALKS 3831Daily dosing	Drug	ALKS 3831
OlanzapineDaily dosing	Drug	Olanzapine

Primary outcome

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

2 secondary outcomes

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

Results and safety

Results posted to the registry on 10 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olanzapine	276	176
ALKS 3831	274	176

Primary outcome: Percent Change From Baseline in Body Weight at Week 24

Time frame: Baseline and Week 24. Least squares mean (Standard Error). Unit: Percent change in body weight

Measure	Olanzapine n = 272	ALKS 3831 n = 266
Value	6.59 (0.668)	4.21 (0.681)

ALKS 3831: Least Squares Mean Difference: -2.38 (95% CI -3.88 to -0.88), p = 0.003, ANCOVA

Population analysed: 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

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

Time frame: Baseline and Week 24. Number. Unit: Percentage of participants

Measure	Olanzapine n = 272	ALKS 3831 n = 266
Value	29.8	17.8

Olanzapine vs ALKS 3831: Risk Difference (RD): -13.7 (95% CI -22.8 to -4.6), p = 0.003, Regression, Logistic

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olanzapine	7 of 276 (2.5%)	159 of 276 (57.6%)	0 of 276
ALKS 3831	10 of 274 (3.6%)	146 of 274 (53.3%)	0 of 274

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36305696Correll CU, Stein E, Graham C, DiPetrillo L, Akerman S, Stanford AD, Jiang Y, Yagoda S, McDonnell D, Hopkinson C. Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study. Schizophr Bull. 2023 Mar 15;49(2):454-463. doi: 10.1093/schbul/sbac144.
Derived from this study: PubMed 36226902Meyer JM, Simmons A, Jiang Y, Graham C, Yagoda S, McDonnell D. Olanzapine/samidorphan combination consistently mitigates weight gain across various subgroups of patients. CNS Spectr. 2023 Aug;28(4):478-481. doi: 10.1017/S1092852922000967. Epub 2022 Oct 13.
Individual participant dataSharing planned: No

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
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Not yet recruitingPhase 1
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Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alkermes Medical Director study director

Alkermes, Inc.

54 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALKS 3831 and Olanzapine in people with Schizophrenia, run by Alkermes, Inc. at 54 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Body Weight at Week 24 (time frame: Baseline and Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02694328, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.