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ClinicalTrials.gov public records Last synced Oct 3, 2026, 10:06 AM EDT

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Showing 1–15 of 15 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Samidorphan + olanzapine (ALKS 3831) Clear all
Completed Phase 2 Interventional Results available

A Study of ALKS 3831 in Adults With Schizophrenia

NCT01903837
View directory record Official record
Conditions
Schizophrenia
Interventions
Samidorphan (Low Dose), Samidorphan (Medium Dose), Samidorphan (High Dose), Placebo, Olanzapine
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
347 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
50
States / cities
Little Rock, Arkansas • Anaheim, California • Costa Mesa, California + 43 more
Source: ClinicalTrials.gov public record
Updated Oct 6, 2021 · Synced Oct 3, 2026, 10:06 AM EDT
Recruiting Phase 3 Interventional

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

NCT05303064
View directory record Official record
Conditions
Schizophrenia, Bipolar I Disorder
Interventions
OLZ/SAM, Olanzapine
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
10 Years to 17 Years
Enrollment
220 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
26
States / cities
Dothan, Alabama • Little Rock, Arkansas • Encino, California + 23 more
Source: ClinicalTrials.gov public record
Updated Aug 14, 2026 · Synced Oct 3, 2026, 10:06 AM EDT
Available No phase listed Expanded access

An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315)

NCT07744113
View directory record Official record
Conditions
Bipolar 1 Disorder, Schizophrenia Disorder
Interventions
OLZ/SAM
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
10 Years to 17 Years
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Aug 4, 2026 · Synced Oct 3, 2026, 10:06 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

An Insulin Sensitivity Study in Healthy Subjects

NCT02922426
View directory record Official record
Conditions
Healthy Volunteers
Interventions
ALKS 3831, Olanzapine, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 40 Years
Enrollment
60 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2017
U.S. locations
1
States / cities
Chula Vista, California
Source: ClinicalTrials.gov public record
Updated Aug 22, 2017 · Synced Oct 3, 2026, 10:06 AM EDT
Completed Phase 3 Interventional Results available

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

NCT03187769
View directory record Official record
Conditions
Schizophrenia, Schizophreniform Disorders, Bipolar I Disorder
Interventions
ALKS 3831, Olanzapine
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
16 Years to 40 Years
Enrollment
426 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
25
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Garden Grove, California + 19 more
Source: ClinicalTrials.gov public record
Updated Jan 19, 2023 · Synced Oct 3, 2026, 10:06 AM EDT
Completed Phase 3 Interventional Results available

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

NCT02694328
View directory record Official record
Conditions
Schizophrenia
Interventions
ALKS 3831, Olanzapine
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
561 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
52
States / cities
Little Rock, Arkansas • Springdale, Arkansas • Anaheim, California + 46 more
Source: ClinicalTrials.gov public record
Updated Feb 10, 2020 · Synced Oct 3, 2026, 10:06 AM EDT
Completed Phase 3 Interventional Results available

A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

NCT02873208
View directory record Official record
Conditions
Schizophrenia
Interventions
ALKS 3831
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
266 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
43
States / cities
Little Rock, Arkansas • Springdale, Arkansas • Anaheim, California + 38 more
Source: ClinicalTrials.gov public record
Updated Jul 21, 2021 · Synced Oct 3, 2026, 10:06 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

NCT05547100
View directory record Official record
Conditions
Focus of Study is on Healthy Lactating Women
Interventions
LYBALVI
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022
U.S. locations
1
States / cities
Las Vegas, Nevada
Source: ClinicalTrials.gov public record
Updated Feb 10, 2023 · Synced Oct 3, 2026, 10:06 AM EDT
Completed Phase 3 Interventional Results available

A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

NCT02634346
View directory record Official record
Conditions
Schizophrenia
Interventions
ALK3831, Olanzapine, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
403 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
16
States / cities
Little Rock, Arkansas • Springdale, Arkansas • Culver City, California + 13 more
Source: ClinicalTrials.gov public record
Updated Jun 27, 2018 · Synced Oct 3, 2026, 10:06 AM EDT
Enrolling by invitation Phase 3 Interventional

Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

NCT04987229
View directory record Official record
Conditions
Bipolar I Disorder, Schizophrenia
Interventions
OLZ/SAM
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
10 Years to 17 Years
Enrollment
236 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
15
States / cities
Dothan, Alabama • Little Rock, Arkansas • Stanford, California + 12 more
Source: ClinicalTrials.gov public record
Updated Aug 14, 2026 · Synced Oct 3, 2026, 10:06 AM EDT
Completed Phase 3 Interventional Results available

Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

NCT03201757
View directory record Official record
Conditions
Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder
Interventions
ALKS 3831
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
16 Years to 70 Years
Enrollment
523 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2023
U.S. locations
49
States / cities
Little Rock, Arkansas • Rogers, Arkansas • Anaheim, California + 40 more
Source: ClinicalTrials.gov public record
Updated Sep 26, 2024 · Synced Oct 3, 2026, 10:06 AM EDT
Completed Phase 3 Interventional Results available

A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

NCT02669758
View directory record Official record
Conditions
Schizophrenia
Interventions
ALKS 3831
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
281 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
14
States / cities
Little Rock, Arkansas • Springdale, Arkansas • Culver City, California + 11 more
Source: ClinicalTrials.gov public record
Updated Jul 26, 2019 · Synced Oct 3, 2026, 10:06 AM EDT
Completed Phase 1 Interventional

A Phase 1 Safety Study in Adults With Schizophrenia

NCT02804568
View directory record Official record
Conditions
Schizophrenia
Interventions
ALKS 3831
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
42 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016
U.S. locations
3
States / cities
Little Rock, Arkansas • Clementon, New Jersey • Dayton, Ohio
Source: ClinicalTrials.gov public record
Updated Sep 22, 2016 · Synced Oct 3, 2026, 10:06 AM EDT
Completed Phase 2 Interventional Results available

A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder

NCT02161718
View directory record Official record
Conditions
Schizophrenia, Alcohol Use Disorder
Interventions
Samidorphan + olanzapine (ALKS 3831), Placebo + olanzapine
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
58
States / cities
Little Rock, Arkansas • Springdale, Arkansas • Anaheim, California + 50 more
Source: ClinicalTrials.gov public record
Updated Oct 8, 2021 · Synced Oct 3, 2026, 10:06 AM EDT
Completed Phase 1 Interventional

Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder

NCT04987658
View directory record Official record
Conditions
Bipolar I Disorder
Interventions
OLZ/SAM
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
10 Years to 12 Years
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
2
States / cities
Decatur, Georgia • Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Nov 22, 2023 · Synced Oct 3, 2026, 10:06 AM EDT