Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05320146
  4. Details
NCT05320146 Clinical Trial

A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:
A Phase 1b, Open-Label Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Adult Patients With Presumed Nonalcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05320146
Other study ID # CORT118335-861 - Sub Study
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 4, 2022
Est. completion date August 2024

Study information
Verified date August 2023
Source Corcept Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)

Description:

This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH). All patients who participated in the current study (CORT118335-861) or the Corcept Phase 2a NASH study (CORT118335-860), and who received at least one dose of miricorilant will be eligible for participation in an observational follow-up study; this includes patients who either terminated early or are study completers.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 22
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Have participated in either Study CORT118335-861 (current study) or Study CORT118335-860 (Corcept Phase 2a NASH study) and received at least one dose of miricorilant; this includes patients who terminated early from the study or completed the study. - Have not participated in any other clinical trial following study completion in either Study CORT118335-861 or Study CORT118335-860.

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • Non-alcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis (NASH)

Intervention

Other:
• MRI-PDFF
Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) is a MRI-based diagnostic imaging biomarker of the liver.

Locations
Country Name City State
United States Site 211 Austin Texas
United States Site 207 Chandler Arizona
United States Site 213 Edinburg Texas
United States 305 Houston Texas
United States Site 214 Panorama City California
United States Site 212 San Antonio Texas
United States Site 233 Santa Ana California
United States Site 210 Sarasota Florida
United States 226 Seattle Washington
United States Site 209 Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in liver-fat content assessed by MRI-PDFF after the last dose of study drug. Baseline Day 1 up to Month 12
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04880031 - A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) Phase 2
Suspended NCT04104321 - A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR) Phase 3
Completed NCT02891408 - Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function Phase 1
Completed NCT04546984 - Multiple Dose Safety, Tolerability, PK，PD and Food Effect Study of HEC96719 in Healthy Adult Subjects Phase 1
Recruiting NCT05842512 - Study of ADI-PEG 20 Versus Placebo in Subjects With NASH Phase 2
Completed NCT02854605 - Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH) Phase 2
Recruiting NCT06108219 - A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH) Phase 2
Recruiting NCT03572465 - Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis
Active, not recruiting NCT05402371 - A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis Phase 2
Terminated NCT03823703 - Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH) Phase 2
Recruiting NCT05117489 - A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH) Phase 1
Completed NCT04165343 - Evaluation of Multi-Organ Metabolism and Perfusion in NAFLD by Total Body Dynamic PET Scan on EXPLORER
Recruiting NCT04913090 - A Phase I Clinical Trial of XZP-5610 Tablets in Healthy Subjects Phase 1
Recruiting NCT06024408 - A Trial to Learn if Receiving ALN-PNP siRNA is Safe and Well Tolerated, and How it Works in Adult Participants With Nonalcoholic Fatty Liver Disease (NAFLD) and a Genetic Risk Factor Phase 1
Terminated NCT04004325 - A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis Phase 1/Phase 2
Completed NCT06037577 - Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects Phase 1
Completed NCT01265498 - The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT) Phase 2
Terminated NCT00845845 - Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH) Phase 2
Terminated NCT04267393 - Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH) Phase 2
Completed NCT04616014 - A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH) Phase 2

External Links