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

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03823703
• Other study ID #: CORT118335-860
• Status: Terminated
• Phase: Phase 2
• 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
• 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.

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

External Links

•   Poster #:LP34