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This phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
This phase 1b, Open-Label Study will assess the safety, efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH).
Patients who meet the criteria for the study CORT-118335-861 will be enrolled on Day 1 into 1 of 11 cohorts and receive:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - 150 mg of miricorilant for 24 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 24 weeks. |
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| Cohort 2 - 150 mg of miricorilant for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 12 weeks. |
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| Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily for 2 weeks, followed by 100 mg of miricorilant every Monday, Wednesday and Friday for 10 weeks. |
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| Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 2 weeks, followed by 100 mg of miricorilant every Monday and Friday for 10 weeks. |
|
| Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miricorilant 150 mg | Drug | Miricorilant 150 mg for oral dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline. | Baseline Day 1 up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in aspartate aminotransferase (AST). | Baseline Day 1 up to Week 24 | |
| Change from Baseline in alanine aminotransferase (ALT). | Baseline Day 1 up to Week 24 | |
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Inclusion Criteria:
Have a diagnosis of NASH based on a biopsy obtained within the last year OR Have a diagnosis of presumed NASH based on blood tests and scans
Exclusion Criteria:
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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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 7, 2026 | |
| Reset | Jan 22, 2026 | |
| Release | Mar 16, 2026 |
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| Experimental |
Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday, Wednesday and Friday for 12 weeks. |
|
| Cohort 6 - 100 mg of miricorilant every MF for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday and Friday for 12 weeks. |
|
| Cohort 7 - 50 mg of miricorilant daily for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 50 mg once daily, for 12 weeks. |
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| Cohort 8 - 100 mg of miricorilant daily for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 12 weeks. |
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| Cohort 9 - 30 mg of miricorilant daily for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 30 mg once daily, for 12 weeks. |
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| Cohort 10 - 200 mg of miricorilant once a week for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 200 mg once weekly, for 12 weeks. |
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| Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg twice weekly for 12 weeks. |
|
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| Miricorilant 100 mg | Drug | Miricorilant 100 mg for oral dosing |
|
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| Miricorilant 50 mg | Drug | Miricorilant 50 mg for oral dosing |
|
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| Miricorilant 10 mg | Drug | Miricorilant 10 mg for oral dosing. |
|
|
| Change from Baseline in gamma-glutamyl transferase (GGT). |
| Baseline Day 1 up to Week 24 |
| Change from baseline in enhanced liver fibrosis score (ELF). | ELF numerical values are calculated from serum measurements of hyaluronic acid (HA), tissue inhibitor of metalloproteinases-1 (TIMP-1), and type III procollagen (PIIINP) using the formula: ELF score = 2.494 + 0.846 In [HA] + 0.735 In [PIIINP] + 0.391 In [TIMP-1], and range on a continuous scale. Liver fibrosis is unlikely with scores <6.7 and increasingly likely with higher scores. | Baseline Day 1 up to Week 24 |
| 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 |
| Site 305 | Houston | Texas | 77079 | United States |
| Site 212 | San Antonio | Texas | 78229 | United States |
| 226 | Seattle | Washington | 98105 | United States |
| Reset | Apr 2, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 7, 2026 | Jan 22, 2026 | |||
| Mar 16, 2026 | Apr 2, 2026 | |||
| Jun 23, 2026 |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000606526 | CORT118335 |
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