NCT03818256

A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This phase 2, double blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese adults with schizophrenia or bipolar disorder treated with antipsychotic medications.

Detailed 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.

Conditions

• Antipsychotic-induced Weight Gain (AIWG)

Interventions

Type	Name	Description
DRUG	Miricorilant	Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
DRUG	Placebo	Placebo tablets for once-daily oral dosing

Timeline

• Start date: 2019-12-04
• Primary completion: 2022-06-17
• Completion: 2022-07-06
• First posted: 2019-01-28
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study