This Phase 2, Double Blind, Placebo-controlled, Randomized Study is to Assess the Safety and Efficacy of Miricorilant in Obese Adult With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications.
Trial ID or NCT#
NCT03818256
Status
RECRUITING
Purpose
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant in obese adult 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 (CORT118335) in Obese Adult Patients With Schizophrenia or Bipolar Disorder and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)
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 or bipolar disorder - Are currently taking oral or injectable atypical antipsychotic medication (except clozapine) and must have documented weight gain while on these medications - Must be on a stable dose of medication for 1 month prior to screening - Are able to successfully complete placebo tablet swallow test - 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
Investigator(s)
Jacob S. Ballon
Psychiatrist
Associate Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology)
View on ClinicalTrials.gov
