A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)

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)

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.

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.