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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)
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Site #143
Bentonville, Arkansas, United States
Site # 249
Little Rock, Arkansas, United States
Site #153
Culver City, California, United States
Site #239
Garden Grove, California, United States
Site # 243
Glendale, California, United States
Site #134
Lemon Grove, California, United States
Site #163
Oceanside, California, United States
Site # 247
Pico Rivera, California, United States
Site # 229
Rancho Cucamonga, California, United States
Site # 237
San Diego, California, United States
Start Date
September 9, 2020
Primary Completion Date
July 29, 2022
Completion Date
August 25, 2022
Last Updated
June 13, 2024
150
ACTUAL participants
Miricorlilant
DRUG
Miricorlilant
DRUG
Placebo
DRUG
Lead Sponsor
Corcept Therapeutics
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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