Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03823703
Other study ID # CORT118335-860
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 4, 2020
Est. completion date April 5, 2021

Study information

Verified date April 2021
Source Corcept Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).


Description:

This is a randomized, double-blind, placebo-controlled study that assessed the safety efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH). Patients who meet the criteria for Study CORT118335-860 were randomized on Day 1 to receive 900 mg miricorilant, 600 mg miricorilant, or placebo for 12 weeks. Due to observations related to safety, the study was terminated prior to completion and study objectives, endpoints, and procedures were modified as specified in the protocol.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date April 5, 2021
Est. primary completion date April 5, 2021
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/m^2 - 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
Tablets taken orally
Placebo
Placebo tablets

Locations

Country Name City State
United States Site 211 Austin Texas
United States Site 207 Chandler Arizona
United States Site 232 East Syracuse New York
United States Site 213 Edinburg Texas
United States Site 215 Edinburg Texas
United States Site 208 Glendale Arizona
United States Site 228 Kansas City Missouri
United States Site 227 Los Angeles California
United States Site 214 Panorama City California
United States Site 234 Port Orange Florida
United States Site 212 San Antonio Texas
United States Site 233 Santa Ana California
United States Site 210 Sarasota Florida
United States Site 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
Other Number of Participants With a Relative Reduction in Liver Fat Content =50% by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) for Miricorilant Versus Placebo Baseline and up to ~Day 95
Other Number of Participants With Complete Resolution in Liver Fat by MRI-PDFF for Miricorilant Versus Placebo Baseline and up to ~Day 95
Primary Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: ([Post-Baseline LFC-Baseline LFC]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups. Baseline and up to ~Day 95
Secondary Number of Participants Achieving a Relative Reduction From Baseline in LFC of =30% by MRI-PDFF The number of participants (defined as responders) with a =30% reduction in LFC from baseline by treatment group as assessed by MRI-PDFF. The number of participants with a reduction in LFC from baseline of <30% were defined as non-responders. MRI-PDFF was performed at screening and up to 33 days after last dose of study drug. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups. Baseline and up to ~Day 95
Secondary Change From Baseline in Aspartate Aminotransferase The change in aspartate aminotransferase (AST) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups. Baseline and Week 6
Secondary Change From Baseline in Alanine Aminotransferase The change in serum alanine aminotransferase (ALT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups. Baseline and Week 6
Secondary Change From Baseline in Gamma-glutamyl Transferase The change in gamma-glutamyl transferase (GGT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups. Baseline and Week 6
Secondary Change From Baseline in Propeptide of Type III Collagen The change in serum propeptide of Type III collagen (pro-C3) from baseline at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups. Baseline and Week 6
Secondary Change From Baseline in Enhanced Liver Fibrosis Score The change in enhanced liver fibrosis (ELF) from baseline for each treatment group at the Week 6 visit is summarized. The ELF score combines 3 serum biomarkers (hyaluronic acid, tissue inhibitor of metalloproteinases-1 [TIMP-1] and type III procollagen [PIIINP]) which have been shown to correlate with the degree of liver fibrosis assessed by liver biopsy. Each of these markers is measured by an immunoassay and an ELF score is generated [ELF=2.278+0.851 ln(HA)+0.751 ln(PIIINP)+0.394 ln(TIMP-1)], from which a level of fibrosis severity can be determined; higher ELF scores are associated with worsening liver fibrosis. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups. Baseline and Week 6
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
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
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

External Links