Nonalcoholic Steatohepatitis (NASH)Phase 1NCT05117489
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
A Phase 1 study testing Miricorilant 150 mg, Miricorilant 100 mg and Miricorilant 50 mg in people with Nonalcoholic Steatohepatitis (NASH), run by Corcept Therapeutics at 9 sites in United States.
Trial summary
This 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?
- Miricorilant 150 mg, Miricorilant 100 mg and Miricorilant 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 9 sitesUnited States
- Study dates
- 23 Nov 2021to 29 Jan 2024
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of NASH based on a biopsy obtained within the last year OR Have a diagnosis of presumed NASH based on blood tests and scans
Who cannot join
- Have participated in another clinical trial within the last year and received active treatment for NASH
- Have participated in another clinical trial for any other indication within the last 3 months
- Are pregnant or lactating women
- Have a BMI <18 kg/m2
- Have had liver transplantation or plan to have liver transplantation during the study
- Have type 1 diabetes or poorly controlled type 2 diabetes.
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
Site 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 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 phase 1b, Open-Label Study will assess the safety, efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH).
Patients who meet the criteria for the study CORT-118335-861 will be enrolled on Day 1 into 1 of 11 cohorts and receive:
- Cohort 1 - a daily dose of 150 mg of miricorilant over 24 weeks.
- Cohort 2 - a daily dose of 150 mg of miricorilant over 12 weeks.
- Cohort 3 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday, Wednesday and Friday.
- Cohort 4 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday and Friday.
- Cohort 5 - a thrice weekly dose of 100 mg of miricorilant over 12 weeks every Monday, Wednesday, and Friday.
- Cohort 6 - a twice weekly dose of 100 mg of miricorilant over 12 weeks every Monday and Friday.
- Cohort 7 - a daily dose of 50 mg of miricorilant over 12 weeks.
- Cohort 8 - a daily dose of 100 mg of miricorilant over 12 weeks.
- Cohort 9 - a daily dose of 30 mg of miricorilant over 12 weeks.
- Cohort 10 - a once weekly dose of 200 mg of miricorilant over 12 weeks.
- Cohort 11 - a twice weekly dose of 150 mg miricorilant over 12 weeks.
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Being tested
- Miricorilant 150 mg, Miricorilant 100 mg, Miricorilant 50 mg, Miricorilant 10 mg
- 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.
Miricorilant 150 mgDrug
Also called CORT118335
Miricorilant 150 mg for oral dosing
Miricorilant 100 mgDrug
Also called CORT118335
Miricorilant 100 mg for oral dosing
Miricorilant 50 mgDrug
Also called CORT118335
Miricorilant 50 mg for oral dosing
Miricorilant 10 mgDrug
Also called CORT118335
Miricorilant 10 mg for oral dosing.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - 150 mg of miricorilant for 24 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 24 weeks. Receives: Drug: Miricorilant 150 mg |
| Cohort 2 - 150 mg of miricorilant for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 12 weeks. Receives: Drug: Miricorilant 150 mg |
| Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily for 2 weeks, followed by 100 mg of miricorilant every Monday, Wednesday and Friday for 10 weeks. Receives: Drug: Miricorilant 100 mg |
| Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 2 weeks, followed by 100 mg of miricorilant every Monday and Friday for 10 weeks. Receives: Drug: Miricorilant 100 mg |
| Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday, Wednesday and Friday for 12 weeks. Receives: Drug: Miricorilant 100 mg |
| Cohort 6 - 100 mg of miricorilant every MF for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday and Friday for 12 weeks. Receives: Drug: Miricorilant 100 mg |
| Cohort 7 - 50 mg of miricorilant daily for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 50 mg once daily, for 12 weeks. Receives: Drug: Miricorilant 50 mg |
| Cohort 8 - 100 mg of miricorilant daily for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 12 weeks. Receives: Drug: Miricorilant 50 mg |
| Cohort 9 - 30 mg of miricorilant daily for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 30 mg once daily, for 12 weeks. Receives: Drug: Miricorilant 10 mg |
| Cohort 10 - 200 mg of miricorilant once a week for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 200 mg once weekly, for 12 weeks. Receives: Drug: Miricorilant 50 mg |
| Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeks | Experimental | Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg twice weekly for 12 weeks. Receives: Drug: Miricorilant 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.
Measured: Baseline Day 1 up to Week 24
Secondary outcomes (4)
Change from Baseline in aspartate aminotransferase (AST).
Measured: Baseline Day 1 up to Week 24
Change from Baseline in alanine aminotransferase (ALT).
Measured: Baseline Day 1 up to Week 24
Change from Baseline in gamma-glutamyl transferase (GGT).
Measured: Baseline Day 1 up to Week 24
Change from baseline in enhanced liver fibrosis score (ELF).
ELF numerical values are calculated from serum measurements of hyaluronic acid (HA), tissue inhibitor of metalloproteinases-1 (TIMP-1), and type III procollagen (PIIINP) using the formula: ELF score = 2.494 + 0.846 In [HA] + 0.735 In [PIIINP] + 0.391 In [TIMP-1], and range on a continuous scale. Liver fibrosis is unlikely with scores <6.7 and increasingly likely with higher scores.
Measured: Baseline Day 1 up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start23 Nov 2021
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT05117489
- Sponsor's protocol ID
- CORT118335-861
- Status last verified
- Aug 2024
- First submitted
- 12 Oct 2021
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
- NCT05117489
- Acronym / sponsor ID
- CORT118335-861
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Keywords
- Nonalcoholic Steatohepatitis, NASH, Nonalcoholic Fatty Liver Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 11 Nov 2021 (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 phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)
Detailed description
This phase 1b, Open-Label Study will assess the safety, efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH).
Patients who meet the criteria for the study CORT-118335-861 will be enrolled on Day 1 into 1 of 11 cohorts and receive:
- Cohort 1 - a daily dose of 150 mg of miricorilant over 24 weeks.
- Cohort 2 - a daily dose of 150 mg of miricorilant over 12 weeks.
- Cohort 3 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday, Wednesday and Friday.
- Cohort 4 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday and Friday.
- Cohort 5 - a thrice weekly dose of 100 mg of miricorilant over 12 weeks every Monday, Wednesday, and Friday.
- Cohort 6 - a twice weekly dose of 100 mg of miricorilant over 12 weeks every Monday and Friday.
- Cohort 7 - a daily dose of 50 mg of miricorilant over 12 weeks.
- Cohort 8 - a daily dose of 100 mg of miricorilant over 12 weeks.
- Cohort 9 - a daily dose of 30 mg of miricorilant over 12 weeks.
- Cohort 10 - a once weekly dose of 200 mg of miricorilant over 12 weeks.
- Cohort 11 - a twice weekly dose of 150 mg miricorilant over 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - 150 mg of miricorilant for 24 weeks | Experimental | Drug: Miricorilant 150 mgPatients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 24 weeks. |
| Cohort 2 - 150 mg of miricorilant for 12 weeks | Experimental | Drug: Miricorilant 150 mgPatients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 12 weeks. |
| Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks | Experimental | Drug: Miricorilant 100 mgPatients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily for 2 weeks, followed by 100 mg of miricorilant every Monday, Wednesday and Friday for 10 weeks. |
| Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks | Experimental | Drug: Miricorilant 100 mgPatients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 2 weeks, followed by 100 mg of miricorilant every Monday and Friday for 10 weeks. |
| Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks | Experimental | Drug: Miricorilant 100 mgPatients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday, Wednesday and Friday for 12 weeks. |
| Cohort 6 - 100 mg of miricorilant every MF for 12 weeks | Experimental | Drug: Miricorilant 100 mgPatients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday and Friday for 12 weeks. |
| Cohort 7 - 50 mg of miricorilant daily for 12 weeks | Experimental | Drug: Miricorilant 50 mgPatients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 50 mg once daily, for 12 weeks. |
| Cohort 8 - 100 mg of miricorilant daily for 12 weeks | Experimental | Drug: Miricorilant 50 mgPatients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 12 weeks. |
| Cohort 9 - 30 mg of miricorilant daily for 12 weeks | Experimental | Drug: Miricorilant 10 mgPatients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 30 mg once daily, for 12 weeks. |
| Cohort 10 - 200 mg of miricorilant once a week for 12 weeks | Experimental | Drug: Miricorilant 50 mgPatients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 200 mg once weekly, for 12 weeks. |
| Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeks | Experimental | Drug: Miricorilant 50 mgPatients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg twice weekly for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have a diagnosis of NASH based on a biopsy obtained within the last year OR Have a diagnosis of presumed NASH based on blood tests and scans
Key exclusion criteria (6 listed)
- Have participated in another clinical trial within the last year and received active treatment for NASH
- Have participated in another clinical trial for any other indication within the last 3 months
- Are pregnant or lactating women
- Have a BMI <18 kg/m2
- Have had liver transplantation or plan to have liver transplantation during the study
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 |
|---|---|---|
| Miricorilant 150 mgAlso: CORT118335Miricorilant 150 mg for oral dosing | Drug | Cohort 1 - 150 mg of miricorilant for 24 weeks, Cohort 2 - 150 mg of miricorilant for 12 weeks |
| Miricorilant 100 mgAlso: CORT118335Miricorilant 100 mg for oral dosing | Drug | Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks, Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks, Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks, Cohort 6 - 100 mg of miricorilant every MF for 12 weeks |
| Miricorilant 50 mgAlso: CORT118335Miricorilant 50 mg for oral dosing | Drug | Cohort 10 - 200 mg of miricorilant once a week for 12 weeks, Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeks, Cohort 7 - 50 mg of miricorilant daily for 12 weeks, Cohort 8 - 100 mg of miricorilant daily for 12 weeks |
| Miricorilant 10 mgAlso: CORT118335Miricorilant 10 mg for oral dosing. | Drug | Cohort 9 - 30 mg of miricorilant daily for 12 weeks |
Primary outcome
Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.
Time frame: Baseline Day 1 up to Week 24
4 secondary outcomes
Change from Baseline in aspartate aminotransferase (AST).
Time frame: Baseline Day 1 up to Week 24
Change from Baseline in alanine aminotransferase (ALT).
Time frame: Baseline Day 1 up to Week 24
Change from Baseline in gamma-glutamyl transferase (GGT).
Time frame: Baseline Day 1 up to Week 24
Change from baseline in enhanced liver fibrosis score (ELF).
Time frame: Baseline Day 1 up to Week 24
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.
- Individual participant dataSharing planned: No
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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?
A Phase 1 study testing Miricorilant 150 mg, Miricorilant 100 mg and Miricorilant 50 mg in people with 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 1 inclusion and 6 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline. (time frame: Baseline Day 1 up to Week 24). 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.