Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04524403 | A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II) | PHASE2 | COMPLETED | 150 | — | — | Sep 9, 2020 | Aug 25, 2022 | Jun 13, 2024 | 40 | United States |
| Arm | Type | Description |
|---|---|---|
| Miricorlilant 600 mg | EXPERIMENTAL | Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks. |
| Miricorlilant 900 mg | EXPERIMENTAL | Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks. |
| Placebo | PLACEBO_COMPARATOR | Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks. |
| Name | Type | Description |
|---|---|---|
| Miricorlilant | DRUG | Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing |
| Placebo | DRUG | Placebo for once-daily oral dosing |
Inclusion Criteria: * Have a diagnosis of schizophrenia * Are currently taking olanzapine, risperidone, paliperidone, or quetiapine and have gained weight from treatment while on these medications * Must be on a stable dose of medication for 1 month prior to Screening * Have a BMI ≥30 kg/m\^2. Exc...