NCT05117489

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonalcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	Miricorilant 150 mg	Miricorilant 150 mg for oral dosing
DRUG	Miricorilant 100 mg	Miricorilant 100 mg for oral dosing
DRUG	Miricorilant 50 mg	Miricorilant 50 mg for oral dosing
DRUG	Miricorilant 10 mg	Miricorilant 10 mg for oral dosing.

Timeline

• Start date: 2021-11-23
• Primary completion: 2024-01-29
• Completion: 2024-01-29
• First posted: 2021-11-11
• Last updated: 2024-08-19

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study