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 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ALKS 3831-A307
• Study Type: interventional
• Target: 426
• Locations: 12 countries
• Sites: 57

Brief Summary

This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness

Conditions

Schizophrenia; Schizophreniform Disorders; Bipolar I Disorder

Keywords

Alkermes; ALKS 3831; Olanzapine; Samidorphan; Schizophrenia; Schizophreniform; Bipolar I

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Body Weight at Week 12

  The efficacy analyses were performed using the Final Analysis Set which is defined as all randomized subjects who received one dose of study drug and had at least 1 primary efficacy assessment after administration of study drug

  Baseline and 12 weeks

Secondary Outcomes (5)

• Percentage of Subjects With ≥10% Weight Gain at Week 12

  Baseline and 12 weeks

• Percentage of Subjects With ≥7% Weight Gain at Week 12

  Baseline and 12 weeks

• Number of Participants Experiencing of Adverse Events (AEs)

  Up to 16 weeks

• Change From Baseline in Waist Circumference at Week 12

  Baseline and Week 12

• Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score Within the ALKS 3831 Group at Week 12

  Baseline and Week 12

Study Arms (2)

ALKS 3831

EXPERIMENTAL

Coated bilayer tablet

Drug: ALKS 3831

Olanzapine

ACTIVE COMPARATOR

Coated bilayer tablet

Drug: Olanzapine

Interventions

ALKS 3831 DRUG

Olanzapine + samidorphan, daily oral dosing

ALKS 3831

Olanzapine DRUG

Daily oral dosing

Olanzapine

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Has less than 24 weeks previous treatment with antipsychotics (cumulative; lifetime)
• Subject treated with aripiprazole can receive an additional 1 year of treatment at ≤5 mg/day, and this treatment will not be considered as part of the 24 weeks of previous treatment with antipsychotics
• Has less than 4 years elapse since the initial onset of active-phase of symptoms
• Has a body mass index (BMI) of \<30 kg/m\^2
• Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after the last dose of study drug
• Subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder
• For bipolar I disorder, must have been experiencing an episode of acute mania within ≤14 days prior to Visit 1
• Suitable for outpatient treatment
• Additional criteria may apply

You may not qualify if:

• Poses a current suicide risk
• Has a history of poor or inadequate response to treatment with olanzapine
• Has previously been treated with long-acting injectable antipsychotic medication within the 2 months prior to screening, or has \> 6 months cumulative life use, or has received treatment with electroconvulsive therapy in their lifetime
• Has initiated treatment with mood stabilizers (eg lithium, valproate, etc) \>2 months prior to Visit 1
• Has a positive drug screen for opioids, phencyclidine (PCP), amphetamine/methamphetamine, or cocaine
• Has taken opioid agonists (eg, codeine, oxycodone, tramadol, morphine) within the 14 days prior to Visit 1, or has taken opioid antagonists, including naltrexone and naloxone, within 60 days prior to Visit 1
• Taking any weight loss agents or hypoglycemic agents
• Has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of efficacy
• Has joined a weight management program or had significant changes in diet or exercise regimen within the past 6 weeks
• Has started a smoking cessation program within the past 6 months
• Has a history of diabetes
• Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
• Additional criteria may apply

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (57)

Alkermes Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Alkermes Investigational Site

Rogers, Arkansas, 72758, United States

Location

Alkermes Investigational Site

Garden Grove, California, 92845, United States

Location

Alkermes Investigational Site

San Diego, California, 92013, United States

Location

Alkermes Investigational Site

Stanford, California, 94305, United States

Location

Alkermes Investigational Site

Jacksonville, Florida, 32209, United States

Location

Alkermes Investigational Site

North Miami, Florida, 33161, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30303, United States

Location

Alkermes Investigational Site

Atlanta, Georgia, 30331, United States

Location

Alkermes Investigational Site

Augusta, Georgia, 30912, United States

Location

Alkermes Investigational Site

Chicago, Illinois, 60611, United States

Location

Alkermes Investigational Site

Winfield, Illinois, 60190, United States

Location

Alkermes Investigational Site

Kalamazoo, Michigan, 49001, United States

Location

Alkermes Investigational Site

Kansas City, Missouri, 64108, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63110, United States

Location

Alkermes Investigational Site

St Louis, Missouri, 63118, 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

Cincinnati, Ohio, 45219, United States

Location

Alkermes Investigational Site

Eugene, Oregon, 97401, United States

Location

Alkermes Investigational Site

DeSoto, Texas, 75115, United States

Location

Alkermes Investigational Site

Fort Worth, Texas, 76104, United States

Location

Alkermes Investigational Site

Houston, Texas, 77030, United States

Location

Alkermes Investigational Site

Richardson, Texas, 75080, United States

Location

Alkermes Investigational Site

San Antonio, Texas, 78201, United States

Location

Alkermes Investigational Site

Vienna, Austria

Location

Alkermes Investigational Site

München, Germany

Location

Alkermes Investigational Site

Galway, Ireland

Location

Alkermes Investigational Site

Jerusalem, Israel

Location

Alkermes Investigational Site

Tel Litwinsky, Israel

Location

Alkermes Investigational Site

Brescia, Italy

Location

Alkermes Investigational Site

Naples, Italy

Location

Alkermes Investigational Site

Torino, Italy

Location

Alkermes Investigational Site

Poznan, Poland

Location

Alkermes Investigational Site

Arkhangelsk, Russia

Location

Alkermes Investigational Site

Moscow, Russia

Location

Alkermes Investigational Site

Roshchino, Russia

Location

Alkermes Investigational Site

Rostov-on-Don, Russia

Location

Alkermes Investigational Site

Saint Petersburg, Russia

Location

Alkermes Investigational Site

Samara, Russia

Location

Alkermes Investigational Site

Saratov, Russia

Location

Alkermes Investigational Site

Tonnel’nyy, Russia

Location

Alkermes Investigational Site

Busan, South Korea

Location

Alkermes Investigational Site

Daegu, South Korea

Location

Alkermes Investigational Site

Naju, South Korea

Location

Alkermes Investigational Site

Seoul, South Korea

Location

Alkermes Investigational Site

Oviedo, Spain

Location

Alkermes Investigational Site

Kharkiv, Ukraine

Location

Alkermes Investigational Site

Kyiv, Ukraine

Location

Alkermes Investigational Site

Lviv, Ukraine

Location

Alkermes Investigational Site

Poltava, Ukraine

Location

Alkermes Investigational Site

Smila, Ukraine

Location

Alkermes Investigational Site

Stepanovka, Ukraine

Location

Alkermes Investigational Site

Guildford, United Kingdom

Location

Alkermes Investigational Site

Headington, United Kingdom

Location

Alkermes Investigational Site

London, United Kingdom

Location

Alkermes Investigational Site

Maidstone, United Kingdom

Location

Related Publications (1)

• Kahn RS, Kane JM, Correll CU, Arevalo C, Simmons A, Graham C, Yagoda S, Hu B, McDonnell D. Olanzapine/Samidorphan in Young Adults With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder Who Are Early in Their Illness: Results of the Randomized, Controlled ENLIGHTEN-Early Study. J Clin Psychiatry. 2023 Mar 22;84(3):22m14674. doi: 10.4088/JCP.22m14674.

  PMID: 36946605 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Global Clinical Services
• Organization: Alkermes

clinicaltrials@alkermes.com

888-253-8008

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: June 8, 2017
• First Posted: June 15, 2017
• Study Start: June 8, 2017
• Primary Completion: December 1, 2021
• Study Completion: January 3, 2022
• Last Updated: January 19, 2023
• Results First Posted: January 19, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

UA (6); US (25); AU (1); IL (2); GB (4); PL (1); ES (1); IT (3); IE (1); RU (8); KR (4); DE (1)