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This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH).
All patients who participated in the current study (CORT118335-861) or the Corcept Phase 2a NASH study (CORT118335-860), and who received at least one dose of miricorilant will be eligible for participation in an observational follow-up study; this includes patients who either terminated early or are study completers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CORT118335-860 Participants | This group will include patients who participated in CORT118335-860 study and received at least one dose of miricorilant. |
| |
| CORT118335-861 Participants | This group will include patients who participated in CORT118335-861 study and received at least one dose of miricorilant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI-PDFF | Other | Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a MRI-based diagnostic imaging biomarker of the liver. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver-fat content assessed by MRI-PDFF after the last dose of study drug. | Baseline Day 1 up to Month 12 |
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Inclusion Criteria:
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Patients that have previously enrolled in CORT118335-860 or in CORT118335-861 and have received at least one dose of miricorilant.
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| Name | Affiliation | Role |
|---|---|---|
| Kavita Juneja, MD | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 207 | Chandler | Arizona | 85224 | United States | ||
| Site 209 |
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| Label | URL |
|---|---|
| Clinical Trial public posting for CORT113885-860 | View source |
| Clinical Trial public posting for CORT118335-861 | View source |
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Whole blood and Serum samples will be retained.
| Tucson |
| Arizona |
| 85712 |
| United States |
| Site 214 | Panorama City | California | 91402 | United States |
| Site 233 | Santa Ana | California | 92704 | United States |
| Site 211 | Austin | Texas | 78757 | United States |
| Site 213 | Edinburg | Texas | 78539 | United States |
| 305 | Houston | Texas | 77079 | United States |
| Site 212 | San Antonio | Texas | 78229 | United States |
| 226 | Seattle | Washington | 98105 | United States |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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