This Phase 2, Double Blind, Placebo-controlled, Randomized Study is to Assess the Safety and Efficacy of Miricorilant in Obese Adult With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications.

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 in obese adult 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 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.

Official Title
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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)

Conditions
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Antipsychotic-induced Weight Gain (AIWG)

Intervention / Treatment
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* Drug: Miricorilant
* Drug: Miricorilant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of schizophrenia or bipolar disorder Are currently taking oral or injectable atypical antipsychotic medication (except clozapine) and must have documented weight gain while on these medications Must be on a stable dose of medication for 1 month prior to screening Are able to successfully complete placebo tablet swallow test 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

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: CORT118335- 600 mg<br>Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive 600 mg miricorilant for 12 weeks. | Drug: Miricorilant<br>* Miricorilant 600mg<br>|
| Placebo Comparator: Placebo<br>Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive placebo for 12 weeks. | Drug: Miricorilant<br>* Placebo tablets for once daily 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 at Week 12 for 600 mg miricorilant versus placebo |  | Baseline Day 1 to Week 12 | 
| Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation |  | Up to Follow-up Visit (up to Week 16) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving more than or equal to 5% weight loss | Percentage of patients achieving more than or equal to 5% weight loss for 600 mg miricorilant versus placebo | Baseline Day 1 to week 12 | 
| Change from baseline in Homeostatic model assessment for insulin resistance (HOMA-IR) at Week 12 | Change in insulin resistance (HOMA-IR) for 600 mg miricorilant versus placebo | Baseline Day 1 to week 12 | 
| Change from baseline in waist-to-hip ratio at Week 12 | 600 mg Miricorilant versus placebo | Baseline Day1 to week 12 | 

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