drugset / Trial / NCT05463770

A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia

NCT05463770

NaSingle-groupOpen-labelTreatment

Summary

A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia and assess whether it changes: * how the body processes (uses) glucose (blood sugar) * how much insulin the pancreas can make. Insulin is a hormone that lowers blood sugar levels in the body. The information from this study will help to understand any effect the study medication may have on how the body uses and stores glucose. This study is accepting both male and female subjects. It will be held in approximately 6 locations in the United States. Participation could last up to 12 weeks.

Timeline

Start
2022-08-30
Primary completion
2023-08-22
Completion
2023-08-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulotaront Small molecule 12.5 mg Oral
Subject Ulotaront Small molecule 25 mg Oral
Subject Ulotaront Small molecule 50 mg Oral

Indications