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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ulotaront | Small molecule | 12.5 mg | Oral |
| Subject | Ulotaront | Small molecule | 25 mg | Oral |
| Subject | Ulotaront | Small molecule | 50 mg | Oral |