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

September 28, 2023 updated by: Corcept Therapeutics

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Active, not recruiting
        • Site 207
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Site 209
    • California
      • Panorama City, California, United States, 91402
        • Recruiting
        • Site 214
      • Santa Ana, California, United States, 92704
        • Recruiting
        • Site 233
    • Florida
      • Sarasota, Florida, United States, 34240
        • Withdrawn
        • Site 210
    • Texas
      • Austin, Texas, United States, 78757
        • Recruiting
        • Site 211
      • Edinburg, Texas, United States, 78539
        • Active, not recruiting
        • Site 213
      • Houston, Texas, United States, 77079
        • Recruiting
        • Site 305
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Site 212
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • 226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 - 150 mg of miricorilant for 24 weeks
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.
Drug: Miricorilant 150 mg
Miricorilant 150 mg for oral dosing
Other Names:
  • CORT118335
Experimental: Cohort 2 - 150 mg of miricorilant for 12 weeks
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.
Drug: Miricorilant 150 mg
Miricorilant 150 mg for oral dosing
Other Names:
  • CORT118335
Experimental: Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks
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.
Drug: Miricorilant 100 mg
Miricorilant 100 mg for oral dosing
Other Names:
  • CORT118335
Experimental: Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks
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.
Drug: Miricorilant 100 mg
Miricorilant 100 mg for oral dosing
Other Names:
  • CORT118335
Experimental: Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks
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.
Drug: Miricorilant 100 mg
Miricorilant 100 mg for oral dosing
Other Names:
  • CORT118335
Experimental: Cohort 6 - 100 mg of miricorilant every MF for 12 weeks
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.
Drug: Miricorilant 100 mg
Miricorilant 100 mg for oral dosing
Other Names:
  • CORT118335
Experimental: Cohort 7 - 50 mg of miricorilant daily for 12 weeks
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.
Drug: Miricorilant 50 mg
Miricorilant 50 mg for oral dosing
Other Names:
  • CORT118335
Experimental: Cohort 8 - 100 mg of miricorilant daily for 12 weeks
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.
Drug: Miricorilant 50 mg
Miricorilant 50 mg for oral dosing
Other Names:
  • CORT118335
Experimental: Cohort 9 - 30 mg of miricorilant daily for 12 weeks
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.
Drug: Miricorilant 10 mg
Miricorilant 10 mg for oral dosing.
Other Names:
  • CORT118335
Experimental: Cohort 10 - 200 mg of miricorilant once a week for 12 weeks
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.
Drug: Miricorilant 50 mg
Miricorilant 50 mg for oral dosing
Other Names:
  • CORT118335
Experimental: Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeks
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.
Drug: Miricorilant 50 mg
Miricorilant 50 mg for oral dosing
Other Names:
  • CORT118335

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.
Time Frame: Baseline Day 1 up to Week 24
Baseline Day 1 up to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in aspartate aminotransferase (AST).
Time Frame: Baseline Day 1 up to Week 24
Baseline Day 1 up to Week 24
Change from Baseline in alanine aminotransferase (ALT).
Time Frame: Baseline Day 1 up to Week 24
Baseline Day 1 up to Week 24
Change from Baseline in gamma-glutamyl transferase (GGT).
Time Frame: Baseline Day 1 up to Week 24
Baseline Day 1 up to Week 24
Change from baseline in enhanced liver fibrosis score (ELF).
Time Frame: Baseline Day 1 up to Week 24
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.
Baseline Day 1 up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corcept Therapeutics

Investigators

  • Study Director: Kavita Juneja, MD, Corcept Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 11, 2021

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORT118335-861

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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