Skip to main content
OpenTrials
Completed

NCT Number: NCT05117489

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in 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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nonalcoholic Steatohepatitis (NASH) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site 207, Chandler, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Miricorilant 150 mg

Drug

Miricorilant 150 mg for oral dosing

Other names: CORT118335

Miricorilant 100 mg

Drug

Miricorilant 100 mg for oral dosing

Other names: CORT118335

Miricorilant 50 mg

Drug

Miricorilant 50 mg for oral dosing

Other names: CORT118335

Miricorilant 10 mg

Drug

Miricorilant 10 mg for oral dosing.

Other names: CORT118335

Primary outcomes

  1. Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.

    Time frame: Baseline Day 1 up to Week 24

Secondary outcomes

  1. Change from Baseline in aspartate aminotransferase (AST).

    Time frame: Baseline Day 1 up to Week 24

  2. Change from Baseline in alanine aminotransferase (ALT).

    Time frame: Baseline Day 1 up to Week 24

  3. Change from Baseline in gamma-glutamyl transferase (GGT).

    Time frame: Baseline Day 1 up to Week 24

  4. 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.

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study title

A Phase 1b, Open-Label Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Adult Patients With Presumed Nonalcoholic Steatohepatitis (NASH)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 11, 2021
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.