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.
