Nonalcoholic Steatohepatitis (NASH) Clinical Trial
Official title:
A Phase 1b, Open-Label Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Adult Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
This phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
| Status | Recruiting |
| Enrollment | 70 |
| Est. completion date | August 2024 |
| Est. primary completion date | August 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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: - Have participated in another clinical trial within the last year and received active treatment for NASH - Have participated in another clinical trial for any other indication within the last 3 months - Are pregnant or lactating women - Have a BMI <18 kg/m2 - Have had liver transplantation or plan to have liver transplantation during the study - Have type 1 diabetes or poorly controlled type 2 diabetes. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Site 211 | Austin | Texas |
| United States | Site 207 | Chandler | Arizona |
| United States | Site 213 | Edinburg | Texas |
| United States | Site 305 | Houston | Texas |
| United States | Site 214 | Panorama City | California |
| United States | Site 212 | San Antonio | Texas |
| United States | Site 233 | Santa Ana | California |
| United States | Site 210 | Sarasota | Florida |
| United States | 226 | Seattle | Washington |
| United States | Site 209 | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Corcept Therapeutics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline. | Baseline Day 1 up to Week 24 | ||
| Secondary | Change from Baseline in aspartate aminotransferase (AST). | Baseline Day 1 up to Week 24 | ||
| Secondary | Change from Baseline in alanine aminotransferase (ALT). | Baseline Day 1 up to Week 24 | ||
| Secondary | Change from Baseline in gamma-glutamyl transferase (GGT). | Baseline Day 1 up to Week 24 | ||
| Secondary | 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 |
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