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

Completed

Brief Summary: 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)

Detailed Description: 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.

Recruitment & Eligibility

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.

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Change in liver-fat content assessed by MRI-PDFF after the last dose of study drug.	Baseline Day 1 up to Month 12

Secondary Outcome Measures

Name	Time	Method

Locations (9): Site 207
🇺🇸
Chandler, Arizona, United States
Site 209
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Tucson, Arizona, United States
Site 214
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Panorama City, California, United States
Site 233
🇺🇸
Santa Ana, California, United States
Site 211
🇺🇸
Austin, Texas, United States
Site 213
🇺🇸
Edinburg, Texas, United States
305
🇺🇸
Houston, Texas, United States
Site 212
🇺🇸
San Antonio, Texas, United States
226
🇺🇸
Seattle, Washington, United States
Site 207
🇺🇸Chandler, Arizona, United States