Non-alcoholic Steatohepatitis (NASH)Phase 1NCT05553470
Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Miricorilant
A Phase 1 study testing Miricorilant in people with Non-alcoholic Steatohepatitis (NASH), run by Corcept Therapeutics at 3 sites in United States.
Trial summary
The primary objective of this study is to determine the effect of hepatic impairment on the pharmacokinetics (PK) of miricorilant following a single oral dose by comparing participants with normal hepatic function with participants with moderate hepatic impairment with or without nonalcoholic steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Steatohepatitis (NASH)
- What is being tested?
- Miricorilant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Mar 2022to 13 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoker or light smokers (no more than 5 cigarettes/day or nicotine equivalent) with BMI ≥18.0 and ≤32 kg/m2 and body weight ≥50.0 kg.
- Female participants must be non-childbearing or willing to use an acceptable intra-uterine contraceptive device 4 weeks prior and throughout the study and for 90 days after study drug administration.
- Male participants who are sexually active must be willing to use an acceptable contraceptive method from dosing until at least 90 days after study drug administration.
- Total abstinence from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the participant.
- Male participants must be willing to not donate sperm until 90 days following the administration of the study drug.
- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m^2 at screening, by the Modification of Diet in Renal Disease, 4 variable (MDRD4) Equation.
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- Additional Inclusion Criteria for Control Group Participants Only:
- On a population basis, matched to participants with moderate hepatic impairment according to gender, age (± 10 years), and weight (± 20 %).
- Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic (including cholecystectomy), and metabolic disease.
- Non-clinically significant deviation for laboratory tests results (albumin ≥ the lower limit of normal (LLN), total bilirubin ≤ ULN, aspartate aminotransferase (AST) ≤ upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ ULN, alkaline phosphatase ≤ ULN).
- Additional Inclusion Criteria for Participants With Hepatic Impairment Only:
- Participant with stable hepatic impairment (Child-Pugh [CP] class A or B according to group)
- Documented parenchymal hepatic disease as evidenced by ultrasonography, computed tomography (CT), magnetic resonance imaging (MRI), or biopsy.
- Participants who have chronic (≥ 6 months) mild or moderate hepatic impairment that has been clinically stable
- Have hepatic impairment as assessed by a CP classification score: Mild (5-6 points), or Moderate (7-9 points) impaired hepatic function with known medical history of liver disease.
- Have non-clinically significant findings at physical examination and in clinically laboratory evaluations.
- Moderate hepatic impairment participants with nonalcoholic steatohepatitis (NASH) only should have a history or presence of metabolic syndrome or type 2 diabetes, clinical characteristics or prior liver biopsy, ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women, and except for participants with prior liver biopsy, participants should have currently or previously one of the following: MRI-iron-corrected T1 (cT1) value > 800 ms, MRI proton density fat fraction (PDFF) liver fat content ≥ 8 % or FibroScan liver stiffness measurement (LSM) ≥ 8.5 kilopascals (kPa).
Who cannot join
- Clinically significant illness or surgery within 4 weeks prior to dosing.
- Gastrointestinal surgery that interferes with physiological absorption and motility or gastric bands.
- Clinically significant history or presence of any gastrointestinal pathology, or unresolved gastrointestinal symptoms that can interfere with drug absorption.
- History of suicidal tendency, disposition to seizures, state of confusion, or clinically relevant psychiatric diseases.
- Any medical condition that could be aggravated by glucocorticoid antagonism, and/or mineralocorticoid antagonism, such as autoimmune disease, rheumatic disease, hypotension, or postural hypotension.
- Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities at screening
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- Acute viral hepatitis in the 6 calendar months before the administration of the study drug.
- Positive to Coronavirus disease 2019 (COVID-19) test at screening
- History of Gilbert's syndrome
- Uncontrolled hyperlipidemia
- History of significant drug abuse within 1 year prior to screening or recreational use of soft drugs within 1 month or hard drugs within 3 months prior to screening, unless for hepatic impaired participants only, the participants uses any of these drugs as prescriptions.
- History of significant alcohol abuse within six months prior to screening or regular use of alcohol within six months prior to the screening visit.
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the dosing.
- Female participants with a positive pregnancy test.
- Participant with a positive alcohol test at screening.
- History of allergic reactions to miricorilant or other related drugs
- Known clinically significant hypersensitivity to any of the ingredients or excipients of the study drug
- Previous participation in a study with miricorilant administration.
- Participated in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing.
- Participants who have taken oral, parenteral, depot or intra-articular glucocorticoids within 12 months prior to study drug administration; or intranasal, topical, or inhaled glucocorticoids within 2 weeks prior to study drug administration.
- Male participants (including men who have had vasectomies) with a pregnant or lactating partner.
- Breast-feeding female participants
- Inability or difficulty to swallow tablets
- Inability to be venipunctured and/or tolerate catheter venous access.
- Additional Exclusion Criteria for Healthy Group (No Hepatic Impairment) Participants Only:
- Previously documented parenchymal hepatic disease evidenced by, for example, ultrasonography, computed tomography, magnetic resonance imaging, or biopsy.
- Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HBsAg, HCV, or HIV at screening;
- Participants using medication other than topical products without significant systemic absorption.
- Participants with a positive urine drug screen at screening.
- Additional Exclusion Criteria for Participants with Hepatic Impairment Only:
- Clinically significant unstable medical conditions or clinically significant acute exacerbation of hepatic disease within 30 days of study drug administration
- Clinically significant abnormalities of laboratory, ECG, or clinical data that would preclude participation in the study
- Presence of chronic kidney disease (CKD).
- Presence of hepatocellular carcinoma or acute hepatic disease from infection or drug toxicity
- Presence of clinically significant history of lactic acidosis and severe hepatomegaly with steatosis
- Presence of active stage 2, 3 or stage 4 hepatic encephalopathy
- Evidence of severe ascites
- Type 1 or uncontrolled Type 2 diabetes
- Presence of surgically-created or transjugular intrahepatic portal systemic shunts.
- Positive test for HIV
- Positive drug screen at screening
- Use of prohibited concomitant medication
- History or clinical evidence of hepatic decompensation or other severe liver impairment.
- History of liver transplant, or current placement on a liver transplant list.
- For moderate hepatic impairment participants with NASH, a history or clinical evidence of chronic liver diseases other than nonalcoholic fatty liver disease (NAFLD).
- Weight loss of > 5% total body weight within 3 months prior to screening.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Site 01
Miami, Florida, 33136
Site 02
Miami Lakes, Florida, 33104
Site 03
Rialto, California, 92377
About this study
Official title: A Phase 1, Open-label, Single-dose, Adaptive Design Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Miricorilant
The primary objective of this study is to determine the effect of hepatic impairment on the pharmacokinetics (PK) of miricorilant following a single oral dose by comparing participants with normal hepatic function with participants with moderate hepatic impairment with or without nonalcoholic steatohepatitis (NASH).
Read the detailed description
A reduced, adaptive study design will be used to compare the PK of miricorilant between participants with normal hepatic function and participants with hepatic impairment according to the Child-Pugh (CP) classification. Initially, participants with moderate hepatic impairment will be enrolled. Since indications for the development of miricorilant include participants with NASH, 3 or 4 of these participants will have NASH. Healthy control participants will be selected matched to these participants with moderate hepatic impairment according to gender, age (± 10 years), and weight (± 20 %) using a mean matching procedure. Based on the observed effect of moderate hepatic impairment on the miricorilant PK profile following an interim PK analysis, an optional group of participants with mild hepatic impairment may be evaluated. This optional group, matched to the participants with moderate hepatic impairment using the same procedure, will be enrolled to evaluate the effect of mild hepatic impairment on miricorilant PK.
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Being tested
- Miricorilant
- 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.
MiricorilantDrug
Also called CORT118335
600 mg miricorilant
| Study group | Role | What they receive |
|---|---|---|
| No Hepatic Impairment | Experimental | Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets. Receives: Drug: Miricorilant |
| Moderate Hepatic Impairment | Experimental | Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets. Receives: Drug: Miricorilant |
| Mild Hepatic Impairment | Experimental | Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets. Receives: Drug: Miricorilant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Concentration-Time Curve (AUC) from Time Zero to the Last Non-Zero Concentration (AUC 0-t)
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose
AUC from Time Zero to Infinity (AUC0-∞)
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose
Secondary outcomes (5)
Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Day 7
Number of Participants with One or More Serious Adverse Events (SAEs)
Measured: Up to 30 days after study drug administration
Number of Participants with Clinically-Significant Vital Sign Abnormality
Measured: Day -1, pre-dose and ~ 1, 2, 4, and 24 hours post-dose.
Number of Participants with Clinically-Significant 12-Lead Electrocardiogram (ECG) Abnormality
Measured: Day -1, pre-dose and ~1, 2, 4, and 24 hours post-dose, and up to ~Day 7
Number of Participants with Clinically-Significant Laboratory Test Abnormality
Measured: Day -1 and up to ~Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start3 Mar 2022
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Custodio, PhD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553470
- Sponsor's protocol ID
- CORT118335-854
- Status last verified
- Mar 2025
- First submitted
- 21 Sep 2022
- Last updated
- 30 Mar 2025
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-dose, Adaptive Design Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Miricorilant
- ClinicalTrials.gov ID
- NCT05553470
- Acronym / sponsor ID
- CORT118335-854
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 23 Sep 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.
The primary objective of this study is to determine the effect of hepatic impairment on the pharmacokinetics (PK) of miricorilant following a single oral dose by comparing participants with normal hepatic function with participants with moderate hepatic impairment with or without nonalcoholic steatohepatitis (NASH).
Detailed description
A reduced, adaptive study design will be used to compare the PK of miricorilant between participants with normal hepatic function and participants with hepatic impairment according to the Child-Pugh (CP) classification. Initially, participants with moderate hepatic impairment will be enrolled. Since indications for the development of miricorilant include participants with NASH, 3 or 4 of these participants will have NASH. Healthy control participants will be selected matched to these participants with moderate hepatic impairment according to gender, age (± 10 years), and weight (± 20 %) using a mean matching procedure. Based on the observed effect of moderate hepatic impairment on the miricorilant PK profile following an interim PK analysis, an optional group of participants with mild hepatic impairment may be evaluated. This optional group, matched to the participants with moderate hepatic impairment using the same procedure, will be enrolled to evaluate the effect of mild hepatic impairment on miricorilant PK.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Hepatic Impairment | Experimental | Drug: MiricorilantParticipants will receive a single oral dose of miricorilant (6 X100 mg) tablets. |
| Moderate Hepatic Impairment | Experimental | Drug: MiricorilantParticipants will receive a single oral dose of miricorilant (6 X100 mg) tablets. |
| Mild Hepatic Impairment | Experimental | Drug: MiricorilantParticipants will receive a single oral dose of miricorilant (6 X100 mg) tablets. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Non-smoker or light smokers (no more than 5 cigarettes/day or nicotine equivalent) with BMI ≥18.0 and ≤32 kg/m2 and body weight ≥50.0 kg.
- Female participants must be non-childbearing or willing to use an acceptable intra-uterine contraceptive device 4 weeks prior and throughout the study and for 90 days after study drug administration.
- Male participants who are sexually active must be willing to use an acceptable contraceptive method from dosing until at least 90 days after study drug administration.
- Total abstinence from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the participant.
- Male participants must be willing to not donate sperm until 90 days following the administration of the study drug.
Key exclusion criteria (46 listed)
- Clinically significant illness or surgery within 4 weeks prior to dosing.
- Gastrointestinal surgery that interferes with physiological absorption and motility or gastric bands.
- Clinically significant history or presence of any gastrointestinal pathology, or unresolved gastrointestinal symptoms that can interfere with drug absorption.
- History of suicidal tendency, disposition to seizures, state of confusion, or clinically relevant psychiatric diseases.
- Any medical condition that could be aggravated by glucocorticoid antagonism, and/or mineralocorticoid antagonism, such as autoimmune disease, rheumatic disease, hypotension, or postural hypotension.
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 |
|---|---|---|
| MiricorilantAlso: CORT118335600 mg miricorilant | Drug | Mild Hepatic Impairment, Moderate Hepatic Impairment, No Hepatic Impairment |
Primary outcome
Area under the Concentration-Time Curve (AUC) from Time Zero to the Last Non-Zero Concentration (AUC 0-t)
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose
AUC from Time Zero to Infinity (AUC0-∞)
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose
5 secondary outcomes
Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 7
Number of Participants with One or More Serious Adverse Events (SAEs)
Time frame: Up to 30 days after study drug administration
Number of Participants with Clinically-Significant Vital Sign Abnormality
Time frame: Day -1, pre-dose and ~ 1, 2, 4, and 24 hours post-dose.
Number of Participants with Clinically-Significant 12-Lead Electrocardiogram (ECG) Abnormality
Time frame: Day -1, pre-dose and ~1, 2, 4, and 24 hours post-dose, and up to ~Day 7
Number of Participants with Clinically-Significant Laboratory Test Abnormality
Time frame: Day -1 and up to ~Day 7
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 30 Mar 2025.
- 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.
Joseph Custodio, PhD study director
Corcept Therapeutics
3 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 in people with Non-alcoholic Steatohepatitis (NASH), run by Corcept Therapeutics at 3 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 17 inclusion and 46 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 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Area under the Concentration-Time Curve (AUC) from Time Zero to the Last Non-Zero Concentration (AUC 0-t) (time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose). The study lists 3 primary outcomes in all. 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 30 Mar 2025.