Nonalcoholic Steatohepatitis (NASH)
Conditions
Keywords
Nonalcoholic Steatohepatitis, NASH, Nonalcoholic Fatty Liver Disease
Brief summary
This phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
Detailed description
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: * Cohort 1 - a daily dose of 150 mg of miricorilant over 24 weeks. * Cohort 2 - a daily dose of 150 mg of miricorilant over 12 weeks. * Cohort 3 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday, Wednesday and Friday. * Cohort 4 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday and Friday. * Cohort 5 - a thrice weekly dose of 100 mg of miricorilant over 12 weeks every Monday, Wednesday, and Friday. * Cohort 6 - a twice weekly dose of 100 mg of miricorilant over 12 weeks every Monday and Friday. * Cohort 7 - a daily dose of 50 mg of miricorilant over 12 weeks. * Cohort 8 - a daily dose of 100 mg of miricorilant over 12 weeks. * Cohort 9 - a daily dose of 30 mg of miricorilant over 12 weeks. * Cohort 10 - a once weekly dose of 200 mg of miricorilant over 12 weeks. * Cohort 11 - a twice weekly dose of 150 mg miricorilant over 12 weeks.
Interventions
DRUGMiricorilant 150 mg
Miricorilant 150 mg for oral dosing
DRUGMiricorilant 100 mg
Miricorilant 100 mg for oral dosing
DRUGMiricorilant 50 mg
Miricorilant 50 mg for oral dosing
DRUGMiricorilant 10 mg
Miricorilant 10 mg for oral dosing.
Sponsors
Corcept Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline. | Baseline Day 1 up to Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Change from Baseline in gamma-glutamyl transferase (GGT). | Baseline Day 1 up to Week 24 | — |
| Change from baseline in enhanced liver fibrosis score (ELF). | Baseline Day 1 up to Week 24 | 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. |
Countries
United States
Outcome results
None listed