drugset / Trial / NCT06649214
A Study of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this \[clinical trial\] is to \[evaluate the safety and efficacy of olanzapine-samidorphan tablets\] in \[adults with schizophrenia\]. The main question\[s\] it aims to answer are: * \[question 1\] Olanzapine-samidorphan significantly mitigate weight gain better than olanzapine. * \[question 2\] Olanzapine- samidorphan and olanzapine have similar antipsychotic efficacy.
Timeline
- Start
- 2024-11
- Primary completion
- 2026-04
- Completion
- 2026-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Olanzapine | Small molecule | 10 mg | Oral |
| Comparator | Olanzapine | Small molecule | 15 mg | Oral |
| Comparator | Olanzapine | Small molecule | 20 mg | Oral |
| Subject | Samidorphan | Small molecule | 10 mg | Oral |