Miricorilant Dose Escalation for Nonalcoholic Steatohepatitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nonalcoholic Steatohepatitis+2 More
Miricorilant Dose Escalation - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Nonalcoholic Steatohepatitis
  • Non Alcoholic Steatohepatitis (NASH)

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline Day 1 up to Week 24

Week 24
Change from Baseline in alanine aminotransferase (ALT).
Aspartate Transaminase
Change from Baseline in gamma-glutamyl transferase (GGT).
Change from baseline in enhanced liver fibrosis score (ELF).
Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.

Trial Safety

Trial Design

15 Treatment Groups

Cohort 3 - 300 mg of miricorilant
1 of 15
Cohort 8 - 100 mg of miricorilant for 12 weeks
1 of 15
Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF fo...
1 of 15
Cohort 2 - 150 mg of miricorilant for 12 weeks
1 of 15
Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF f...
1 of 15
Cohort 2 - 150 mg of miricorilant
1 of 15
Cohort 4 - 450 mg of miricorilant
1 of 15
Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks
1 of 15
Cohort 8 - 30 mg of miricorilant for 12 weeks
1 of 15
Cohort 9 - 10 mg of miricorilant for 12 weeks
1 of 15
Cohort 1 - 150 mg of miricorilant for 24 weeks
1 of 15
Cohort 4 - 100 mg daily miriorilant for 2 weeks, followed by 100 mg every MF for...
1 of 15
Cohort 1 - Dose escalation of miricorilant
1 of 15
Cohort 7 - 50 mg of miricorilant for 12 weeks
1 of 15
Cohort 6 - 100 mg of miricorilant every MF for 12 weeks
1 of 15

Experimental Treatment

50 Total Participants · 15 Treatment Groups

Primary Treatment: Miricorilant Dose Escalation · No Placebo Group · Phase 1

Cohort 3 - 300 mg of miricorilant
Drug
Experimental Group · 1 Intervention: Miricorilant 300 mg · Intervention Types: Drug
Cohort 8 - 100 mg of miricorilant for 12 weeks
Drug
Experimental Group · 1 Intervention: Miricorilant 100 mg · Intervention Types: Drug
Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks
Drug
Experimental Group · 1 Intervention: Miricorilant 100 mg · Intervention Types: Drug
Cohort 2 - 150 mg of miricorilant for 12 weeks
Drug
Experimental Group · 1 Intervention: Miricorilant 150 mg · Intervention Types: Drug
Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks
Drug
Experimental Group · 1 Intervention: Miricorilant 100 mg · Intervention Types: Drug
Cohort 2 - 150 mg of miricorilant
Drug
Experimental Group · 1 Intervention: Miricorilant 150 mg · Intervention Types: Drug
Cohort 4 - 450 mg of miricorilant
Drug
Experimental Group · 1 Intervention: Miricorilant 450 mg · Intervention Types: Drug
Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks
Drug
Experimental Group · 1 Intervention: Miricorilant 100 mg · Intervention Types: Drug
Cohort 8 - 30 mg of miricorilant for 12 weeks
Drug
Experimental Group · 1 Intervention: Miricorilant 10 mg · Intervention Types: Drug
Cohort 9 - 10 mg of miricorilant for 12 weeks
Drug
Experimental Group · 1 Intervention: Miricorilant 10 mg · Intervention Types: Drug
Cohort 1 - 150 mg of miricorilant for 24 weeks
Drug
Experimental Group · 1 Intervention: Miricorilant 150 mg · Intervention Types: Drug
Cohort 4 - 100 mg daily miriorilant for 2 weeks, followed by 100 mg every MF for 10 weeks
Drug
Experimental Group · 1 Intervention: Miricorilant 100 mg · Intervention Types: Drug
Cohort 1 - Dose escalation of miricorilant
Drug
Experimental Group · 1 Intervention: Miricorilant Dose Escalation · Intervention Types: Drug
Cohort 7 - 50 mg of miricorilant for 12 weeks
Drug
Experimental Group · 1 Intervention: Miricorilant 50 mg · Intervention Types: Drug
Cohort 6 - 100 mg of miricorilant every MF for 12 weeks
Drug
Experimental Group · 1 Intervention: Miricorilant 100 mg · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline day 1 up to week 24

Who is running the clinical trial?

Corcept TherapeuticsLead Sponsor
60 Previous Clinical Trials
4,834 Total Patients Enrolled
Peter Butler, MDStudy DirectorCorcept Therapeutics
1 Previous Clinical Trials
36 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: November 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria100.0%