No Hepatic Impairment for Non-alcoholic Fatty Liver Disease (NAFLD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-alcoholic Fatty Liver Disease (NAFLD)Miricorilant - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Treatment Effectiveness

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: 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

Day 7
Number of Participants with Clinically-Significant Laboratory Test Abnormality
Hour 24
Number of Participants with Clinically-Significant Vital Sign Abnormality
Day 7
Electrocardiogram
Hour 144
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)
Day 30
Number of Participants with One or More Serious Adverse Events (SAEs)
Up to Day 7
Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)

Trial Safety

Trial Design

3 Treatment Groups

No Hepatic Impairment
1 of 3
Moderate Hepatic Impairment
1 of 3
Mild Hepatic Impairment
1 of 3

Experimental Treatment

36 Total Participants · 3 Treatment Groups

Primary Treatment: No Hepatic Impairment · No Placebo Group · Phase 1

No Hepatic Impairment
Drug
Experimental Group · 1 Intervention: Miricorilant · Intervention Types: Drug
Moderate Hepatic Impairment
Drug
Experimental Group · 1 Intervention: Miricorilant · Intervention Types: Drug
Mild Hepatic Impairment
Drug
Experimental Group · 1 Intervention: Miricorilant · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

Corcept TherapeuticsLead Sponsor
60 Previous Clinical Trials
4,848 Total Patients Enrolled
Joseph Custodio, PhDStudy DirectorCorcept Therapeutics
3 Previous Clinical Trials
118 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are female and non-childbearing or willing to use an acceptable intrauterine contraceptive device 4 weeks prior and throughout the study and for 90 days after study drug administration.
You are not currently engaging in heterosexual intercourse.
You have stable hepatic impairment (Child-Pugh [CP] class A or B according to group).