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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corcept Therapeutics

Criteria

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