A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Interventions
- Other: MRI-PDFF
- Registration Number
- NCT05320146
- Lead Sponsor
- Corcept Therapeutics
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CORT118335-860 Participants MRI-PDFF This group will include patients who participated in CORT118335-860 study and received at least one dose of miricorilant. CORT118335-861 Participants MRI-PDFF This group will include patients who participated in CORT118335-861 study and received at least one dose of miricorilant.
- 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
Trial Locations
- Locations (9)
Site 233
🇺🇸Santa Ana, California, United States
226
🇺🇸Seattle, Washington, United States
305
🇺🇸Houston, Texas, United States
Site 212
🇺🇸San Antonio, Texas, United States
Site 214
🇺🇸Panorama City, California, United States
Site 209
🇺🇸Tucson, Arizona, United States
Site 213
🇺🇸Edinburg, Texas, United States
Site 207
🇺🇸Chandler, Arizona, United States
Site 211
🇺🇸Austin, Texas, United States