Skip to main content
OpenTrials
Completed

NCT Number: NCT05320146

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

This optional sub study is a part of the 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

Observational

Primary location

Site 207, Chandler, Arizona, United States

Loading trial locations.

About this study

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

All patients who participated in the current study (CORT118335-861) or the Corcept Phase 2a NASH study (CORT118335-860), and who received at least one dose of miricorilant will be eligible for participation in an observational follow-up study; this includes patients who either terminated early or are study completers.

Who can participate

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

Inclusion criteria

  • Have participated in either Study CORT118335-861 (current study) or Study CORT118335-860 (Corcept Phase 2a NASH study) and received at least one dose of miricorilant; this includes patients who terminated early from the study or completed the study.
  • Have not participated in any other clinical trial following study completion in either Study CORT118335-861 or Study CORT118335-860.

Treatment and study plan

MRI-PDFF

Other

Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a MRI-based diagnostic imaging biomarker of the liver.

Primary outcomes

  1. Change in liver-fat content assessed by MRI-PDFF after the last dose of study drug.

    Time frame: Baseline Day 1 up to Month 12

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
2022
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2022
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.