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: * 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Miricorilant 150 mg for oral dosing
Miricorilant 100 mg for oral dosing
Miricorilant 50 mg for oral dosing
Site 207
Chandler, Arizona, United States
Site 209
Tucson, Arizona, United States
Site 214
Panorama City, California, United States
Site 233
Santa Ana, California, United States
Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.
Time frame: Baseline Day 1 up to Week 24
Change from Baseline in aspartate aminotransferase (AST).
Time frame: Baseline Day 1 up to Week 24
Change from Baseline in alanine aminotransferase (ALT).
Time frame: Baseline Day 1 up to Week 24
Change from Baseline in gamma-glutamyl transferase (GGT).
Time frame: 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.
Time frame: Baseline Day 1 up to Week 24
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Miricorilant 10 mg for oral dosing.
Site 211
Austin, Texas, United States
Site 213
Edinburg, Texas, United States
Site 305
Houston, Texas, United States
Site 212
San Antonio, Texas, United States
226
Seattle, Washington, United States