Miricorilant for Fatty Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called miricorilant for individuals with a type of fatty liver disease known as MASH, linked to metabolic issues. The main goal is to understand how the body processes the drug and to assess its safety. Participants will receive a single dose of the treatment. Suitable candidates for this trial include those with fatty liver disease and metabolic conditions like type 2 diabetes or high blood pressure, who regularly face related health issues. As a Phase 1 trial, this research aims to understand how miricorilant works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that miricorilant is likely to be safe for humans?
Research has shown that miricorilant has been studied for its effects on liver conditions like fatty liver disease. In these studies, miricorilant was generally well-tolerated, but some important points require consideration. For instance, one study found that a high dose of miricorilant (600 mg per day) helped reduce liver fat. However, the specific side effects at this dose were not detailed in the sources provided.
The current trial, in its early phase, primarily focuses on assessing the safety of miricorilant for humans. Early phase trials involve close monitoring for safety, so less is known about potential side effects compared to treatments in later research stages.
Joining this trial helps researchers learn more about how miricorilant works in the body and its safety for people with liver issues. Participants will provide valuable information on how well individuals tolerate the treatment.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for fatty liver disease, which often focus on lifestyle changes like diet and exercise or medications that target insulin resistance, miricorilant offers a novel approach by directly influencing cortisol activity. Researchers are excited about miricorilant because it works as a selective cortisol modulator, potentially reducing liver fat more effectively and quickly. This unique mechanism of action could provide a new therapeutic avenue for patients who have not responded well to existing treatments, making it a promising candidate in the fight against fatty liver disease.
What evidence suggests that miricorilant might be an effective treatment for fatty liver disease?
Research has shown that miricorilant effectively reduces liver fat and improves liver health. Studies have found that it decreases liver fat and enhances heart and metabolic health. These early results are promising, suggesting that miricorilant may benefit people with fatty liver disease. By adjusting cortisol, a hormone related to fat storage, miricorilant might explain its positive effects. Although more research is needed, these findings offer hope for those considering treatment for fatty liver issues.12345
Who Is on the Research Team?
Aprille Espinueva, PharmD
Principal Investigator
Corcept Therapeutics
Are You a Good Fit for This Trial?
This trial is for adults with fatty liver disease (including NASH/MASH) who have certain levels of liver inflammation or scarring, and signs of metabolic issues like high blood sugar, high blood pressure, abnormal cholesterol, or being overweight. Participants must meet specific lab criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of 60 mg miricorilant
Observation
Participants are observed for pharmacokinetics and safety for 4 days post-dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Miricorilant
Trial Overview
The study is testing the safety and how the body processes a new drug called Miricorilant in people with fatty liver disease. All participants will receive Miricorilant; there is no placebo group.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients who meet the entry criteria for study CORT118335-863 will be administered a single dose of 60 mg miricorilant.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Corcept Therapeutics
Lead Sponsor
Dr. Joseph K. Belanoff
Corcept Therapeutics
Chief Executive Officer since 2014
MD from Stanford University
Dr. William Guyer
Corcept Therapeutics
Chief Medical Officer since 2021
PharmD
Citations
1.
ir.corcept.com
ir.corcept.com/news-releases/news-release-details/corcepts-miricorilant-shows-great-promise-treatment-nonCorcept's Miricorilant Shows Great Promise in Treatment of ...
Phase 1b study demonstrates that miricorilant, a selective cortisol modulator, effectively reduces liver fat, improves liver health and key ...
Evaluation of Miricorilant on Liver Fat in Patients With MASLD
Study Overview. Brief Summary. A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed ...
3.
withpower.com
withpower.com/trial/phase-1-metabolic-dysfunction-associated-steatotic-liver-disease-masld-5-2025-242d2Miricorilant for Fatty Liver Disease
Other studies have found that miricorilant not only reduced liver fat but also improved heart and metabolic health indicators. These early results suggest that ...
Pharmacotherapy for Non-Alcoholic Fatty Liver Disease - PMC
Clesacostat (2–50 mg/d) has demonstrated good efficacy in terms of reducing liver steatosis, and is being developed in combination with the DGAT2 inhibitor ...
Study to Evaluate the Effects of Hepatic Impairment ...
The primary objective of this study is to determine the effect of hepatic impairment on the pharmacokinetics (PK) of miricorilant following a ...
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