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NCT05117489 Clinical Trial

A 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: Recruiting

Administrative data
NCT number NCT05117489
Other study ID # CORT118335-861
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 23, 2021
Est. completion date August 2024

Study information
Verified date September 2023
Source Corcept Therapeutics
Contact Clinical Trial Lead
Phone 650-327-3270
Email Study861ctgov@corcept.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

This phase 1b, Open-Label Study will assess the safety, efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH). Patients who meet the criteria for the study CORT-118335-861 will be enrolled on Day 1 into 1 of 11 cohorts and receive: - Cohort 1 - a daily dose of 150 mg of miricorilant over 24 weeks. - Cohort 2 - a daily dose of 150 mg of miricorilant over 12 weeks. - Cohort 3 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday, Wednesday and Friday. - Cohort 4 - a daily dose of 100 mg of miricorilant over 2 weeks, followed by 10 weeks of dosing at 100 mg miricorilant every Monday and Friday. - Cohort 5 - a thrice weekly dose of 100 mg of miricorilant over 12 weeks every Monday, Wednesday, and Friday. - Cohort 6 - a twice weekly dose of 100 mg of miricorilant over 12 weeks every Monday and Friday. - Cohort 7 - a daily dose of 50 mg of miricorilant over 12 weeks. - Cohort 8 - a daily dose of 100 mg of miricorilant over 12 weeks. - Cohort 9 - a daily dose of 30 mg of miricorilant over 12 weeks. - Cohort 10 - a once weekly dose of 200 mg of miricorilant over 12 weeks. - Cohort 11 - a twice weekly dose of 150 mg miricorilant over 12 weeks.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: Have a diagnosis of NASH based on a biopsy obtained within the last year OR Have a diagnosis of presumed NASH based on blood tests and scans Exclusion Criteria: - Have participated in another clinical trial within the last year and received active treatment for NASH - Have participated in another clinical trial for any other indication within the last 3 months - Are pregnant or lactating women - Have a BMI <18 kg/m2 - Have had liver transplantation or plan to have liver transplantation during the study - Have type 1 diabetes or poorly controlled type 2 diabetes.

Study Design

Related Conditions & MeSH terms

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

Intervention

Drug:
• Miricorilant 150 mg
Miricorilant 150 mg for oral dosing
• Miricorilant 100 mg
Miricorilant 100 mg for oral dosing
• Miricorilant 50 mg
Miricorilant 50 mg for oral dosing
• Miricorilant 10 mg
Miricorilant 10 mg for oral dosing.

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 Site 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 Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline. Baseline Day 1 up to Week 24
Secondary Change from Baseline in aspartate aminotransferase (AST). Baseline Day 1 up to Week 24
Secondary Change from Baseline in alanine aminotransferase (ALT). Baseline Day 1 up to Week 24
Secondary Change from Baseline in gamma-glutamyl transferase (GGT). Baseline Day 1 up to Week 24
Secondary Change from baseline in enhanced liver fibrosis score (ELF). ELF numerical values are calculated from serum measurements of hyaluronic acid (HA), tissue inhibitor of metalloproteinases-1 (TIMP-1), and type III procollagen (PIIINP) using the formula: ELF score = 2.494 + 0.846 In [HA] + 0.735 In [PIIINP] + 0.391 In [TIMP-1], and range on a continuous scale. Liver fibrosis is unlikely with scores <6.7 and increasingly likely with higher scores. Baseline Day 1 up to Week 24
See also
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Completed NCT02891408 - Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function Phase 1
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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
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Terminated NCT03823703 - Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH) Phase 2
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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
Active, not recruiting NCT05320146 - A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
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