A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
A Phase 1b, Open-Label Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Adult Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
1 other identifier
observational
22
1 country
9
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2022
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2022
CompletedFirst Submitted
Initial submission to the registry
April 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2023
CompletedAugust 19, 2024
August 1, 2024
1.4 years
April 1, 2022
August 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in liver-fat content assessed by MRI-PDFF after the last dose of study drug.
Baseline Day 1 up to Month 12
Study Arms (2)
CORT118335-860 Participants
This group will include patients who participated in CORT118335-860 study and received at least one dose of miricorilant.
CORT118335-861 Participants
This group will include patients who participated in CORT118335-861 study and received at least one dose of miricorilant.
Interventions
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a MRI-based diagnostic imaging biomarker of the liver.
Eligibility Criteria
Patients that have previously enrolled in CORT118335-860 or in CORT118335-861 and have received at least one dose of miricorilant.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Site 207
Chandler, Arizona, 85224, United States
Site 209
Tucson, Arizona, 85712, United States
Site 214
Panorama City, California, 91402, United States
Site 233
Santa Ana, California, 92704, United States
Site 211
Austin, Texas, 78757, United States
Site 213
Edinburg, Texas, 78539, United States
305
Houston, Texas, 77079, United States
Site 212
San Antonio, Texas, 78229, United States
226
Seattle, Washington, 98105, United States
Related Links
Biospecimen
Whole blood and Serum samples will be retained.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kavita Juneja, MD
Corcept Therapeutics
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2022
First Posted
April 11, 2022
Study Start
March 4, 2022
Primary Completion
July 18, 2023
Study Completion
July 18, 2023
Last Updated
August 19, 2024
Record last verified: 2024-08