Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
Trial ID or NCT#
NCT04524403
Status
RECRUITING
Purpose
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.
Official Title
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)
Eligibility Criteria
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Jacob S. Ballon
Psychiatrist
Associate Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology)
View on ClinicalTrials.gov
