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.

Recruiting

Trial ID: NCT03818256

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)

Stanford Investigator(s)

Jacob S. Ballon
Jacob S. Ballon

Associate Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology)

Eligibility


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

Intervention(s):

drug: Miricorilant

drug: Miricorilant

Recruiting

Contact Information

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