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

NCT02694328 | Completed Phase 3 Results

• 1 other identifier: ALK3831-A303
• Study Type: interventional
• Target: 561
• Locations: 2 countries
• Sites: 54

Brief Summary

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

Conditions

Schizophrenia

Keywords

Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Olanzapine; Weight

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  Baseline and Week 24

• Number of Participants Experiencing of Adverse Events (AEs)

  24 weeks

Study Arms (2)

ALKS 3831

EXPERIMENTAL

Administered as a coated bilayer tablet

Drug: ALKS 3831

Olanzapine

ACTIVE COMPARATOR

Administered as a coated bilayer tablet

Drug: Olanzapine

Interventions

ALKS 3831 DRUG

Daily dosing

ALKS 3831

Olanzapine DRUG

Daily dosing

Olanzapine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (54)

Alkermes Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Alkermes Investigational Site

Springdale, Arkansas, 72764, United States

Location

Alkermes Investigational Site

Anaheim, California, 92805, United States

Location

Alkermes Investigational Site

Cerritos, California, 90703, United States

Location

Alkermes Investigational Site

Culver City, California, 90230, United States

Location

Alkermes Investigational Site

Garden Grove, California, 92845, United States

Location

Alkermes Investigational Site

Glendale, California, 91206, United States

Location

Alkermes Investigational Site

Long Beach, California, 90822, United States

Location

Alkermes Investigational Site

National City, California, 91950, United States

Location

Alkermes Investigational Site

Oakland, California, 94612, United States

Location

Alkermes Investigational Site

Oceanside, California, 92056, United States

Location

Alkermes Investigational Site

Orange, California, 92868, United States

Location

Alkermes Investigational Site

Pico Rivera, California, 90660, United States

Location

Alkermes Investigational Site

Redlands, California, 92374, United States

Location

Alkermes Investigational Site

San Diego, California, 92103, United States

Location

Alkermes Investigational Site

San Diego, California, 92123, United States

Location

Alkermes Investigational Site

Temecula, California, 92591, United States

Location

Alkermes Investigational Site

Torrance, California, 90502, United States

Location

Alkermes Investigational Site

Washington D.C., District of Columbia, 20016, United States

Location

Alkermes Investigational Site

Lauderhill, Florida, 33319, United States

Location

Alkermes Investigational Site

Miami, Florida, 33136, United States

Location

Alkermes Investigational Site

North Miami, Florida, 33161, United States

Location

Alkermes Investigational Site

Oakland Park, Florida, 33334, United States

Location

Alkermes Investigational Site

Tampa, Florida, 33609, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30329, United States

Location

Alkermes Investigational Site

Augusta, Georgia, 30912, United States

Location

Alkermes Investigational Site

Decatur, Georgia, 30030, United States

Location

Alkermes Investigational Site

Chicago, Illinois, 60640, United States

Location

Alkermes Investigational Site

Grand Rapids, Michigan, 49503, United States

Location

Alkermes Investigational Site

Flowood, Mississippi, 39232, United States

Location

Alkermes Investigational Site

Creve Coeur, Missouri, 63141, United States

Location

Alkermes Investigational Site

O'Fallon, Missouri, 63368, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63128, United States

Location

Alkermes Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Alkermes Investigational Site

Berlin, New Jersey, 08009, United States

Location

Alkermes Investigational Site

Marlton, New Jersey, 08053, United States

Location

Alkermes Investigational Site

Brooklyn, New York, 11235, United States

Location

Alkermes Investigational Site

Jamaica, New York, 11432, United States

Location

Alkermes Investigational Site

New York, New York, 10032, United States

Location

Alkermes Investigational Site

New York, New York, 10035, United States

Location

Alkermes Investigational Site

Rochester, New York, 14615, United States

Location

Alkermes Investigational Site

Wards Island, New York, 10035, United States

Location

Alkermes Investigational Site

Canton, Ohio, 44718, United States

Location

Alkermes Investigational Site

Dayton, Ohio, 45417, United States

Location

Alkermes Investigational Site

Middleburg Heights, Ohio, 44130, United States

Location

Alkermes Investigational Site

Allentown, Pennsylvania, 18104, United States

Location

Alkermes Investigational Site

Austin, Texas, 78754, United States

Location

Alkermes Investigational Site

Austin, Texas, 78759, United States

Location

Alkermes Investigational Site

Dallas, Texas, 75243, United States

Location

Alkermes Investigational Site

DeSoto, Texas, 75115, United States

Location

Alkermes Investigational Site

Houston, Texas, 77030, United States

Location

Alkermes Investigational Site

Bellevue, Washington, 98007, United States

Location

Alkermes Investigational Site

San Juan, PR, 00918, Puerto Rico

Location

Alkermes Investigational Site

San Juan, PR, 00926, Puerto Rico

Location

Related Publications (2)

• 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.

  PMID: 36305696 DERIVED

• 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.

  PMID: 36226902 DERIVED

MeSH Terms

Conditions

Schizophrenia; Body Weight

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Eva Stroynowski
• Organization: Alkermes

Eva.Stroynowski@alkermes.com

781-609-7000

Study Officials

• Alkermes Medical Director

  Alkermes, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: February 29, 2016
• Study Start: March 2, 2016
• Primary Completion: November 7, 2018
• Study Completion: November 7, 2018
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

PR (2); US (52)