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Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)

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.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Miricorlilant
  • drug: Miricorlilant
  • drug: Miricorlilant

Eligibility


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

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting