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

Corcept Therapeutics

Status and phase: Completed; Phase 1

Conditions: Nonalcoholic Steatohepatitis (NASH)

Treatments: Drug: Miricorilant 50 mg; Drug: Miricorilant 100 mg; Drug: Miricorilant 10 mg; Drug: Miricorilant 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05117489

CORT118335-861

Details and patient eligibility

About

This phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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70 participants in 11 patient groups

Cohort 1 - 150 mg of miricorilant for 24 weeks

Experimental group

Description:

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 24 weeks.

Treatment:

Drug: Miricorilant 150 mg

Cohort 2 - 150 mg of miricorilant for 12 weeks

Experimental group

Description:

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 12 weeks.

Treatment:

Drug: Miricorilant 150 mg

Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks

Experimental group

Description:

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily for 2 weeks, followed by 100 mg of miricorilant every Monday, Wednesday and Friday for 10 weeks.

Treatment:

Drug: Miricorilant 100 mg

Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks

Experimental group

Description:

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 2 weeks, followed by 100 mg of miricorilant every Monday and Friday for 10 weeks.

Treatment:

Drug: Miricorilant 100 mg

Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks

Experimental group

Description:

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday, Wednesday and Friday for 12 weeks.

Treatment:

Drug: Miricorilant 100 mg

Cohort 6 - 100 mg of miricorilant every MF for 12 weeks

Experimental group

Description:

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday and Friday for 12 weeks.

Treatment:

Drug: Miricorilant 100 mg

Cohort 7 - 50 mg of miricorilant daily for 12 weeks

Experimental group

Description:

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 50 mg once daily, for 12 weeks.

Treatment:

Drug: Miricorilant 50 mg

Cohort 8 - 100 mg of miricorilant daily for 12 weeks

Experimental group

Description:

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 12 weeks.

Treatment:

Drug: Miricorilant 50 mg

Cohort 9 - 30 mg of miricorilant daily for 12 weeks

Experimental group

Description:

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 30 mg once daily, for 12 weeks.

Treatment:

Drug: Miricorilant 10 mg

Cohort 10 - 200 mg of miricorilant once a week for 12 weeks

Experimental group

Description:

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 200 mg once weekly, for 12 weeks.

Treatment:

Drug: Miricorilant 50 mg

Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeks

Experimental group

Description:

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg twice weekly for 12 weeks.

Treatment:

Drug: Miricorilant 50 mg