drugset / Trial / NCT04524403
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
RandomizedParallel-groupTriple-blindTreatment
Summary
This Phase 2, double-blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese patients with schizophrenia treated with antipsychotic medications.
Timeline
- Start
- 2020-09-09
- Primary completion
- 2022-07-29
- Completion
- 2022-08-25
Outcome
Missed primary endpoint
registry analysis (superiority test); Miricorlilant 600 mg vs Placebo; p = 0.7870; NCT04524403 ↗
registry analysis (superiority test); Miricorlilant 900 mg vs Placebo; p = 0.4018; NCT04524403 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Miricorilant | Small molecule | 600 mg | Oral |
| Subject | Miricorilant | Small molecule | 900 mg | Oral |
Indications
No indication recorded.