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Corticosteroid

Miricorilant for Liver Impairment

Phase 1
Recruiting
Research Sponsored by Corcept Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Control Group Participants Only: Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic (including cholecystectomy), and metabolic disease
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This trial will compare how well miricorilant works in people with different degrees of liver impairment.

Who is the study for?
This trial is for adults with moderate liver problems (hepatic impairment) or nonalcoholic fatty liver disease, who are not heavy smokers and have stable body weight. They must be able to swallow tablets, not have had significant alcohol use recently, and agree to contraception if applicable. People with severe liver issues, recent major illnesses or surgeries, uncontrolled diabetes or other serious health conditions cannot join.Check my eligibility
What is being tested?
The study tests how a single dose of the drug Miricorilant behaves in the body when someone has moderate liver problems compared to those with normal liver function. It's looking at whether having a fatty liver changes how the drug works after one oral dose.See study design
What are the potential side effects?
While specific side effects for Miricorilant aren't listed here, drugs like it can cause stomach upset, potential allergic reactions, changes in blood sugar levels or blood pressure. The study will monitor participants closely for any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have a significant history of major health issues.
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My kidney function, measured by eGFR, is normal or near normal.
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My liver function is impaired but stable.
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I am a non-smoker or light smoker, my BMI is between 18 and 32, and I weigh at least 50 kg.
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I have had stable, mild or moderate liver problems for 6 months or more.
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I have mild or moderate liver disease, confirmed by a CP score.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC from Time Zero to Infinity (AUC0-∞)
Area under the Concentration-Time Curve (AUC) from Time Zero to the Last Non-Zero Concentration (AUC 0-t)
Maximum Observed Plasma Concentration (Cmax)
Secondary outcome measures
Electrocardiogram
Number of Participants with Clinically-Significant Laboratory Test Abnormality
Number of Participants with Clinically-Significant Vital Sign Abnormality
+2 more

Side effects data

From 2022 Phase 2 trial • 50 Patients • NCT04466215
12%
Fatigue
12%
Headache
8%
Abdominal distension
8%
Feeling less euphoric
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
CORT118335

Trial Design

3Treatment groups
Experimental Treatment
Group I: No Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets.
Group II: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets.
Group III: Mild Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Miricorilant
2021
Completed Phase 2
~150

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Corcept TherapeuticsLead Sponsor
68 Previous Clinical Trials
6,344 Total Patients Enrolled
5 Trials studying Non-alcoholic Fatty Liver Disease
280 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Joseph Custodio, PhDStudy DirectorCorcept Therapeutics
4 Previous Clinical Trials
144 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
26 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Miricorilant (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05553470 — Phase 1
Non-alcoholic Fatty Liver Disease Research Study Groups: Mild Hepatic Impairment, No Hepatic Impairment, Moderate Hepatic Impairment
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Miricorilant Highlights & Side Effects. Trial Name: NCT05553470 — Phase 1
Miricorilant (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05553470 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the quota for participants in this experiment filled?

"Affirmative. Per the information hosted on clinicaltrials.gov, recruitment for this research project is currently underway and commenced on October 3rd 2022. The experiment requires 36 participants to be enrolled from 2 distinct sites, with the most recent data update occurring November 2nd 2022."

Answered by AI

Who is eligible to partake in this research?

"This clinical trial is recruiting 36 individuals aged 18 to 75 with steatohepatitis. To be eligible, participants must adhere to these restrictions: Non-smokers or light smokers (no more than 5 cigarettes/day or nicotine equivalent) with a BMI of ≥18.0 and ≤32 kg/m2 as well as body weight ≥50.0kg., Male participants who are sexually active must use an acceptable contraceptive method from dosing until at least 90 days after study drug administration., Males should not donate sperm for 90 days following the administration of the study drug., Estimated glomerular filtration rate (eGFR)"

Answered by AI

Does this medical research venture include seniors aged over 55?

"To be eligible for participation in this medical study, individuals must have attained the age of majority and not exceeded 75 years."

Answered by AI

What risks does Moderate Hepatic Impairment pose to those receiving treatment?

"As Moderate Hepatic Impairment is only in Phase 1 of clinical trials, there is limited research to support its safety and efficacy. Our team at Power has assigned a score of 1 for this therapeutic intervention's risk profile."

Answered by AI

Is participation in this experiment accessible to the public at present?

"As indicated on clinicaltrials.gov, this investigation is presently recruiting participants. It was initially posted in October 3rd 2022 and its details were last refreshed on November 2nd 2022."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Site 01
Site 02
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~0 spots leftby Mar 2024