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Miricorilant for Liver Impairment
Study Summary
This trial will compare how well miricorilant works in people with different degrees of liver impairment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 50 Patients • NCT04466215Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- I have chronic kidney disease and liver problems.My liver condition has been stable for the last 30 days.I have had acute viral hepatitis in the last 6 months.I am healthy with no liver issues and have a negative drug test.I have no history of suicidal tendencies, seizures, confusion, or significant psychiatric conditions.I have a history of severe liver issues and lactic acid buildup.I haven't donated plasma or lost a significant amount of blood recently.I do not have a significant history of major health issues.I have a surgically-created shunt in my liver.My cholesterol levels are very high and not under control.I have severe fluid buildup in my abdomen due to liver issues.I have liver issues and either Type 1 diabetes or uncontrolled Type 2 diabetes.I have moderate liver issues due to NASH, with no other chronic liver diseases.I am not taking any medication that is not allowed due to my liver condition.I have not had any major illness or surgery in the last 4 weeks.I have been diagnosed with Gilbert's syndrome.I am pregnant.I am healthy with no liver issues and only use topical medications.I have liver issues and lost more than 5% of my weight in the last 3 months.I am currently breastfeeding.I do not have severe liver issues that would stop me from joining the study.I have trouble swallowing pills.My liver function is impaired but stable.I have liver cancer or liver disease due to infection or medication.I have had stable, mild or moderate liver problems for 6 months or more.I do not engage in heterosexual intercourse, as per my usual lifestyle choices.My partner is currently pregnant or breastfeeding.I am healthy with no liver issues, significant abnormal tests, or positive for HBsAg, HCV, HIV.I have severe liver impairment with symptoms affecting my brain.I have had a liver transplant or am on the liver transplant list.I have moderate liver issues due to NASH and meet the specific health criteria mentioned.I have liver disease confirmed by an ultrasound, CT, MRI, or biopsy.I have a history of severe liver problems.I am a non-smoker or light smoker, my BMI is between 18 and 32, and I weigh at least 50 kg.I have no liver disease, confirmed by tests like ultrasound or MRI.I have liver issues and tested positive for drugs.I have mild or moderate liver disease, confirmed by a CP score.I agree to use contraception for 90 days after the last dose of the study drug.I haven't taken any form of glucocorticoids recently.I am not able to have children or will use birth control during and after the study.My liver condition doesn't affect my overall health significantly.I agree not to donate sperm for 90 days after taking the study drug.My kidney function, measured by eGFR, is normal or near normal.I don't have major stomach or intestine issues affecting medication absorption.I match the gender, age (± 10 years), and weight (± 20%) of someone with moderate liver issues.I practice total abstinence from heterosexual intercourse as part of my lifestyle.I do not have conditions worsened by certain hormone therapies like autoimmune or low blood pressure issues.I have had stomach surgery that affects how my body processes food.You have had surgery to create a shunt that connects the portal vein to another vein in your liver.I have lost more than 5% of my body weight in the last 3 months.I am not taking any medications that are not allowed in the study.I only use skin-applied medications that don't affect my whole body.
- Group 1: Mild Hepatic Impairment
- Group 2: No Hepatic Impairment
- Group 3: Moderate Hepatic Impairment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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)"
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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