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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing
Miricorilant 900 mg (6 X 150 mg) for once-daily for oral dosing
Placebo for once-daily oral dosing
Change From Baseline in Body Weight
Time frame: Baseline Day 1 and Week 26
Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo
Time frame: Baseline Day 1 and Week 26
Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo
Percentage of patients achieving a ≥5% weight loss for 600 mg miricorilant versus placebo and 900 mg miricorilant versus placebo
Time frame: Baseline Day 1 to Week 26
Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo
Time frame: Baseline Day 1 and Week 26
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