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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)
Recruiting
Trial ID: NCT04524403
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)
Stanford Investigator(s)
Jacob S. Ballon
Associate Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology)
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
Intervention(s):
drug: Miricorlilant
drug: Miricorlilant
drug: Miricorlilant
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305