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

A Study to 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000497-11-AT

Enrollment

425

Registered

2017-06-12

Start date

2017-07-13

Completion date

Unknown

Last updated

2022-03-02

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

Conditions

Schizophrenia, schizophreniform disorder or bipolar I disorder MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 21.1 Level: PT Classification code 10039647 Term: Schizophreniform disorder System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: PT Classification code 10004939 Term: Bipolar I disorder System Organ Class: 10037175 - Psychiatric disorders

Interventions

Product Name: ALKS 3831 5 mg/10 mg Product Code: ALKS 3831 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: OLANZAPINE CAS Number: 132539-06-1 Current Sponsor code: OLZT Concentration unit

ALKS 33 Other descriptive name: SAMIDORPHAN L-MALATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Product Name: ALKS 3831 10 mg/10 mg Product Code: ALKS 383

ALKS 33 Other descriptive name: SAMIDORPHAN L-MALATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Product Name: ALKS 3831 15 mg/10 mg Product Code: ALKS 38

ALKS 33 Other descriptive name: SAMIDORPHAN L-MALATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Product Name: ALKS 3831 20 mg/10 mg Product Code: ALKS 383

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For US sites, men and women =16 through =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Subjects may be excluded based on diagnosis of additional psychiatric conditions, use of prohibited or contraindicated drugs and medications, pre-existing medical conditions, abnormal lab results during Screening, participation in any recent clinical trials or previous clinical trials of ALKS 3831 or samidorphan, pregnancy and relationship to an employee of the study Sponsor, CRO, Investigator, or study site. Please refer to the protocol for full list of Exclusion Criteria

Design outcomes

Primary

Measure	Time frame
Main Objective: To 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;Secondary Objective: To evaluate the safety and tolerability of ALKS 3831 in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness;Primary end point(s): Percent change from baseline in body weight at week 12;Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Main Objective: To 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;Secondary Objective: To evaluate the safety and tolerability of ALKS 3831 in young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in their illness;Primary end point(s): Percent change from baseline in body weight at week 12;Timepoint(s) of evaluation of this end point: Week 12

—

Secondary

Measure	Time frame
Secondary end point(s): - Proportion of subjects with =10% weight gain at week 12 - Proportion of subjects with =7% weight gain at week 12 - Change from baseline in waist circumference at Week 12 - Change from baseline in CGI-S score within the ALKS 3831 Group at Week 12;Timepoint(s) of evaluation of this end point: - Weight gain – week 12	—

Countries

Austria, Germany, Ireland, Israel, Italy, Poland, Spain, United Kingdom, United States

Contacts

Public ContactClinical Development

Alkermes Inc

christina.arevalo@alkermes.com+1781609-6381

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026