A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia

NCT05542264 | Completed Phase 1 FDA Drug

• 1 other identifier: SEP361-122
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

Brief Summary

A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia, and assess wether it affectsbody-weight associated parameters. This study is accepting male and female participants age 18 years to 65 years. This study will be conducted in approximately 6 study sites in the United States. Participation could last up to 13 weeks.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (6)

• Insulin stimulated change in glucose disposal rate during the steady state of the low dose hyperinsulinemic euglycemic clamp (HEC), baseline to end of the treatment

  up to 8 weeks

• Insulin stimulated change in glucose disposal rate during the steady state of the high dose hyperinsulinemic euglycemic clamp (HEC) baseline to end of the treatment.

  up to 8 weeks

• Change in liver proton density fat fraction (PDFF), baseline to end of the treatment

  up to 8 weeks

• Change in fat content in muscles of interest, baseline to end of the treatment

  up to 8 weeks

• Change in Liver Fibroinflammation, baseline to end of the treatment

  up to 8 weeks

• Change in Liver Volume from baseline to end of treatment

  up to 8 weeks

Study Arms (2)

Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)

ACTIVE COMPARATOR

Drug: Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)

SEP-363856

EXPERIMENTAL

Drug: SEP-363856

Interventions

SEP-363856 DRUG

SEP-363856 will be supplied as over-encapsulated tablets. Multiple tablets may be required to achieve a single dose.

SEP-363856

Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole) DRUG

PA will be prepared by the pharmacy staff according to the patient's prescribed treatment and will be orally administered. Multiple tablets or capsules may be required to achieve a single dose.

Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between 18 and 65 years of age, inclusive at time of consent.
• Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview, using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version \[SCID-CT\]).
• Subject must have a Positive and negative symptoms scale (PANSS) total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
• Subject must have a Clinical Global Impressions - Severity (CGI-S) score ≤ 4 (normal to moderately ill) at Screening.
• Subject must be receiving risperidone, olanzapine, quetiapine or aripiprazole as treatment for schizophrenia at the time of Screening.

You may not qualify if:

• Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia or intellectual disability (IQ \< 70).
• Subject has attempted suicide within 12 months prior to Screening.
• Subject answers "yes" to "Suicidal Ideation" Items 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Screening (ie. in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit).
• Subject is at risk of harming him/herself or others according to the Investigator's judgment.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (4)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Shari DeSilva

Rogers, Arkansas, 72758, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856; Risperidone; Olanzapine; Quetiapine Fumarate; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Piperazines; Quinolones; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-Blind, Randomized, Multiple Dose

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: September 15, 2022
• Study Start: November 15, 2022
• Primary Completion: February 12, 2024
• Study Completion: February 12, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

US (4)