NCT04524403

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (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 patients with schizophrenia 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 who are currently taking olanzapine, risperidone, paliperidone, or quetiapine. Patients who meet the criteria for the Study CORT118335-877 will be randomized on Day 1 to receive 600 mg miricorilant, 900 mg miricorilant, or placebo for 26 weeks.

Conditions

• Antipsychotic-induced Weight Gain (AIWG)

Interventions

Type	Name	Description
DRUG	Miricorlilant	Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing
DRUG	Miricorlilant	Miricorilant 900 mg (6 X 150 mg) for once-daily for oral dosing
DRUG	Placebo	Placebo for once-daily oral dosing

Timeline

• Start date: 2020-09-09
• Primary completion: 2022-07-29
• Completion: 2022-08-25
• First posted: 2020-08-24
• Last updated: 2024-06-13
• Results posted: 2024-06-13

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study