Nonalcoholic Steatohepatitis (NASH)NCT05320146
A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
An observational study of Nonalcoholic Steatohepatitis (NASH), run by Corcept Therapeutics at 9 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis (NASH)
- What is being tested?
- MRI-PDFF
- How many people
- 22 participants
- Where
- 9 sitesUnited States
- Study dates
- 4 Mar 2022to 18 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients that have previously enrolled in CORT118335-860 or in CORT118335-861 and have received at least one dose of miricorilant.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Site 211
Austin, Texas, 78757
Site 207
Chandler, Arizona, 85224
Site 213
Edinburg, Texas, 78539
305
Houston, Texas, 77079
Site 214
Panorama City, California, 91402
Site 212
San Antonio, Texas, 78229
Site 233
Santa Ana, California, 92704
226
Seattle, Washington, 98105
Site 209
Tucson, Arizona, 85712
About this study
Official title: A Phase 1b, Open-Label Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Adult 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)
Read the 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.
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Being tested
- MRI-PDFF
- Keywords
- Nonalcoholic Steatohepatitis, NASH, Nonalcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-PDFFOther
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a MRI-based diagnostic imaging biomarker of the liver.
| Study group | Role | What they receive |
|---|---|---|
| CORT118335-860 Participants | This group will include patients who participated in CORT118335-860 study and received at least one dose of miricorilant. Receives: Other: MRI-PDFF | |
| CORT118335-861 Participants | This group will include patients who participated in CORT118335-861 study and received at least one dose of miricorilant. Receives: Other: MRI-PDFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver-fat content assessed by MRI-PDFF after the last dose of study drug.
Measured: Baseline Day 1 up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start4 Mar 2022
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kavita Juneja, MD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320146
- Sponsor's protocol ID
- CORT118335-861 - Sub Study
- Status last verified
- Aug 2024
- First submitted
- 1 Apr 2022
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Adult Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT05320146
- Acronym / sponsor ID
- CORT118335-861 - Sub Study
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Keywords
- Nonalcoholic Steatohepatitis, NASH, Nonalcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CORT118335-860 Participants | – | Other: MRI-PDFFThis group will include patients who participated in CORT118335-860 study and received at least one dose of miricorilant. |
| CORT118335-861 Participants | – | Other: MRI-PDFFThis group will include patients who participated in CORT118335-861 study and received at least one dose of miricorilant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients that have previously enrolled in CORT118335-860 or in CORT118335-861 and have received at least one dose of miricorilant.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI-PDFFMagnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a MRI-based diagnostic imaging biomarker of the liver. | Other | CORT118335-860 Participants, CORT118335-861 Participants |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Clinical Trial public posting for CORT113885-860Link provided by the sponsor.
- Clinical Trial public posting for CORT118335-861Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kavita Juneja, MD study director
Corcept Therapeutics
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Steatohepatitis (NASH), run by Corcept Therapeutics at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.