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

Study Overview
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Brief Summary
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This Phase 2, double-blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in obese patients with schizophrenia treated with antipsychotic medications.

Detailed Description
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This is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and pharmacokinetics (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.

Official Title
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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)

Conditions
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Antipsychotic-induced Weight Gain (AIWG)

Intervention / Treatment
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* Drug: Miricorlilant
* Drug: Miricorlilant
* Drug: Miricorlilant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of schizophrenia Are currently taking olanzapine, risperidone, paliperidone, or quetiapine and have gained weight from treatment while on these medications Must be on a stable dose of medication for 1 month prior to screening Have a BMI ≥30 kg/m2 Exclusion Criteria: Have a history of a medical condition affecting body weight (e.g., poorly controlled hyper- or hypothyroidism; eating disorder such as anorexia, bulimia, or binge eating; or polycystic ovary syndrome). Have poorly controlled diabetes mellitus Have poorly controlled hypertension Have a history of hypotension Have a history of orthostatic hypotension Have a history of a seizure disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Miricorlilant - 600 mg<br>Patients who meet the entry criteria for the Study CORT118335-877 will be randomized to receive 600 mg miricorilant once daily for 26 weeks. | Drug: Miricorlilant<br>* Miricorilant 600mg for oral dosing<br>|
| Experimental: Miricorlilant - 900 mg<br>Patients who meet the entry criteria for the Study CORT118335-877 will be randomized to receive 900 mg miricorilant once daily for 26 weeks. | Drug: Miricorlilant<br>* Miricorilant 900mg for oral dosing<br>|
| Placebo Comparator: Placebo<br>Patients who meet the entry criteria for the Study CORT118335-877 will be randomized to receive placebo once daily for 26 weeks. | Drug: Miricorlilant<br>* Placebo for oral dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in body weight |  | Baseline Day 1 to Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in body weight for both dose levels of miricorilant combined versus placebo | Change from baseline in body weight for both 600 mg and 900 mg dose levels combined of miricorilant versus placebo | Baseline Day 1 to 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 | Baseline Day 1 to Week 26 | 
| Change from baseline in waist-to-hip ratio for miricorilant versus placebo | Both dose levels versus placebo | Baseline Day 1 to Week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antipsychotic-induced weight gain (AIWG), Obesity, Weight Gain, Mental disorders, Schizophrenia, Risperidone, Paliperidone, Quetiapine, Olanzapine