A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia Taking Antipsychotic Medications (GRATITUDE II)

CORT118335-877

This Phase 2, double-blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in obese patients with schizophrenia treated with antipsychotic medications.

2020-09-09

2023-01-31

2023-01-31

Completed

Early phase I

151

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/m2 Exclusion Criteria: * Have a history of a medical condition affecting body weight (e.g., poorly controlled hyper- or hypothyroidism; eating disorder such as anorexia, bulimia, or binge eating; or polycystic ovary syndrome). * Have poorly controlled diabetes mellitus * Have poorly controlled hypertension * Have a history of hypotension * Have a history of orthostatic hypotension * Have a history of a seizure disorder

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Double Blind', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 151, 'type': 'ACTUAL'}}

2023-02-08