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.
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| ClinicalTrials.gov Identifier: NCT03818256 |
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Recruitment Status :
Recruiting
First Posted : January 28, 2019
Last Update Posted : January 20, 2021
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Sponsor:
Corcept Therapeutics
Information provided by (Responsible Party):
Corcept Therapeutics
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Antipsychotic-induced Weight Gain (AIWG) | Drug: Miricorilant | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | Double Blind |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Actual Study Start Date : | October 31, 2019 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | June 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: CORT118335- 600 mg
Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive 600 mg miricorilant for 12 weeks.
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Drug: Miricorilant
Miricorilant 600mg |
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Placebo Comparator: Placebo
Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive placebo for 12 weeks.
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Drug: Miricorilant
Placebo tablets for once daily oral dosing |
Primary Outcome Measures :
- Change from baseline in body weight at Week 12 for 600 mg miricorilant versus placebo [ Time Frame: Baseline Day 1 to Week 12 ]
- Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation [ Time Frame: Up to Follow-up Visit (up to Week 16) ]
Secondary Outcome Measures :
- Percentage of patients achieving more than or equal to 5% weight loss [ Time Frame: Baseline Day 1 to week 12 ]Percentage of patients achieving more than or equal to 5% weight loss for 600 mg miricorilant versus placebo
- Change from baseline in Homeostatic model assessment for insulin resistance (HOMA-IR) at Week 12 [ Time Frame: Baseline Day 1 to week 12 ]Change in insulin resistance (HOMA-IR) for 600 mg miricorilant versus placebo
- Change from baseline in waist-to-hip ratio at Week 12 [ Time Frame: Baseline Day1 to week 12 ]600 mg Miricorilant versus placebo
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818256
Contacts
| Contact: Clinical Trial Lead | 650-688-8806 | study876ctgov@corcept.com |
Locations
Show 27 study locations
Sponsors and Collaborators
Corcept Therapeutics
Investigators
| Study Director: | Ada Lee, MD | Corcept Therapeutics |
| Responsible Party: | Corcept Therapeutics |
| ClinicalTrials.gov Identifier: | NCT03818256 |
| Other Study ID Numbers: |
CORT118335-876 |
| First Posted: | January 28, 2019 Key Record Dates |
| Last Update Posted: | January 20, 2021 |
| Last Verified: | January 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Corcept Therapeutics:
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Antipsychotic-induced weight gain (AIWG) Obesity Weight Gain Mental disorders Schizophrenia |
Risperidone Quetiapine Olanzapine Bipolar Disorder |
Additional relevant MeSH terms:
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Weight Gain Schizophrenia Bipolar Disorder Body Weight |
Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Bipolar and Related Disorders Body Weight Changes |