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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: NCT03818256
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.
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)
- 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
- 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
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