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.

Antipsychotic-induced Weight Gain (AIWG) Clinical Trial

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)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and PK of miricorilant in obese patients with schizophrenia or bipolar disorder who are currently taking oral or injectable atypical antipsychotic medication.

Patients who meet the criteria for the Study CORT118335-876 will be randomized on Day 1 to receive 600 mg miricorilant or placebo for 12 weeks. ;

Related Conditions & MeSH terms

• Antipsychotic-induced Weight Gain (AIWG)
• Bipolar Disorder
• Schizophrenia
• Weight Gain

• NCT number: NCT03818256
• Study type: Interventional
• Source: Corcept Therapeutics
• Status: Completed
• Phase: Phase 2
• Start date: October 31, 2019
• Completion date: December 31, 2022