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Corticosteroid

Miricorilant for Nonalcoholic Steatohepatitis

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
Have a diagnosis of presumed NASH based on blood tests and scans
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline day 1 up to week 24
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective for people with NASH, a liver disease.

Who is the study for?
This trial is for adults with Nonalcoholic Steatohepatitis (NASH), diagnosed through a liver biopsy in the last year or presumed NASH based on blood tests and scans. It's not open to those who've been in another NASH treatment trial within a year, pregnant or breastfeeding women, anyone planning a liver transplant, people with type 1 diabetes or uncontrolled type 2 diabetes, or individuals with a BMI under 18.Check my eligibility
What is being tested?
The study is testing different doses of Miricorilant (10 mg, 50 mg, 100 mg, and 150 mg) to see how safe and effective they are for treating patients with presumed NASH. This phase of the trial will also look at how the body processes the drug.See study design
What are the potential side effects?
Specific side effects of Miricorilant aren't listed here but generally could include gastrointestinal symptoms like nausea or diarrhea, potential liver-related issues since it targets fatty liver disease, as well as possible reactions related to metabolism changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am diagnosed with NASH based on tests and scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline day 1 up to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline day 1 up to week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.
Secondary outcome measures
Change from Baseline in alanine aminotransferase (ALT).
Aspartate Transaminase
Change from Baseline in gamma-glutamyl transferase (GGT).
+1 more

Side effects data

From 2018 Phase 4 trial • 1670 Patients • NCT02261727
32%
COPD Exacerbation - not hospitalised
16%
COPD Exacerbation - Hospitalised
7%
Upper Respiratory Tract Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Low-dose Theophylline Arm
Theophylline and Prednisone Arm

Trial Design

11Treatment groups
Experimental Treatment
Group I: Cohort 9 - 30 mg of miricorilant daily for 12 weeksExperimental Treatment1 Intervention
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.
Group II: Cohort 8 - 100 mg of miricorilant daily for 12 weeksExperimental Treatment1 Intervention
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.
Group III: Cohort 7 - 50 mg of miricorilant daily for 12 weeksExperimental Treatment1 Intervention
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.
Group IV: Cohort 6 - 100 mg of miricorilant every MF for 12 weeksExperimental Treatment1 Intervention
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.
Group V: Cohort 5 - 100 mg of miricorilant every MWF for 12 weeksExperimental Treatment1 Intervention
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.
Group VI: Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeksExperimental Treatment1 Intervention
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.
Group VII: Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeksExperimental Treatment1 Intervention
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.
Group VIII: Cohort 2 - 150 mg of miricorilant for 12 weeksExperimental Treatment1 Intervention
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.
Group IX: Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeksExperimental Treatment1 Intervention
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.
Group X: Cohort 10 - 200 mg of miricorilant once a week for 12 weeksExperimental Treatment1 Intervention
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.
Group XI: Cohort 1 - 150 mg of miricorilant for 24 weeksExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Corcept TherapeuticsLead Sponsor
68 Previous Clinical Trials
6,310 Total Patients Enrolled
5 Trials studying Non-alcoholic Fatty Liver Disease
246 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Peter Butler, MDStudy DirectorCorcept Therapeutics
1 Previous Clinical Trials
22 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
22 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Kavita Juneja, MDStudy DirectorCorcept Therapeutics
4 Previous Clinical Trials
394 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
172 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Miricorilant (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05117489 — Phase 1
Non-alcoholic Fatty Liver Disease Research Study Groups: Cohort 1 - 150 mg of miricorilant for 24 weeks, Cohort 7 - 50 mg of miricorilant daily for 12 weeks, Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks, Cohort 2 - 150 mg of miricorilant for 12 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 10 - 200 mg of miricorilant once a week for 12 weeks, Cohort 6 - 100 mg of miricorilant every MF for 12 weeks, Cohort 8 - 100 mg of miricorilant daily for 12 weeks, Cohort 9 - 30 mg of miricorilant daily for 12 weeks, Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeks
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Miricorilant Highlights & Side Effects. Trial Name: NCT05117489 — Phase 1
Miricorilant (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05117489 — Phase 1

Frequently Asked Questions

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

What other investigations have looked into the effects of escalating Miricorilant doses?

"The Miricorilant Dose Escalation study was first launched in 2021 at Site 305. To date, there are 5 completed trials and 1 ongoing trial based out of Panorama City, CA."

Answered by AI

Is this particular trial pioneering in nature?

"Miricorilant Dose Escalation has been investigated since 2021, with a first study sponsored by Corcept Therapeutics. After the initial trial of 50 participants was completed in 2021, this particular drug successfully navigated Phase 1 approval and is now currently subject to one active clinical trial run by Corcept Therapeutics."

Answered by AI

How many participants are partaking in this experiment?

"This clinical trial requires 50 individuals that meet the established qualifications. The study is available in two different sites, Site 214 located in Panorama City, California and Site 233 found in Santa Ana, Florida."

Answered by AI

Has the FDA sanctioned Miricorilant Dose Escalation?

"Due to the limited amount of data surrounding Miricorilant Dose Escalation, our team has assigned it a score of 1 on our safety scale. This is in accordance with the Phase 1 trial status indicating that efficacy and safety assessments are still underway."

Answered by AI

Is this trial still recruiting participants?

"Affirmative. The clinical trial registry on clinicaltrials.gov notes that the recruitment for this medical study is still ongoing, with an initial posting of November 23rd 2021 and most recent update of October 27th 2022. 50 participants are being sought from 10 distinct sites."

Answered by AI

What type of participant would be best to include in this research?

"A total of 50 participants are required for this clinical trial centered on nonalcoholic steatohepatitis. To be eligible, potential subjects must have the condition and fall between 18 to 75 years old in age."

Answered by AI

Is elderly participation being considered for this clinical investigation?

"Eligibility criteria for this trial mandates that patients are over 18 years old and not exceeding 75 years of age."

Answered by AI

How many distinct facilities are overseeing the trial?

"Currently, this medical study is enrolling participants at Site 214 in Panorama City, California; Site 233 in Santa Ana, Florida; and Site 212 in San Antonio, Arizona as well as 10 additional sites."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
2021. "A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05117489.
All > Autoimmune Hepatitis > Nash
~7 spots leftby Aug 2024
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