Back to resultsStudy Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)
Primary Purpose
Nonalcoholic Steatohepatitis (NASH)
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Miricorilant
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH) focused on measuring Nonalcoholic Steatohepatitis, NASH, Nonalcoholic Fatty Liver Disease
Eligibility Criteria
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.
Sites / Locations
- Site 207
- Site 208
- Site 209
- Site 227
- Site 214
- Site 233
- Site 234
- Site 210
- Site 228
- Site 232
- Site 211
- Site 213
- Site 215
- Site 212
- Site 226
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Miricorilant- 900 mg
Miricorilant- 600 mg
Placebo
Arm Description
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
Participants received 6 placebo tablets orally once daily.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03823703
Brief Title
Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Suspended by sponsor, pending investigation of abnormal laboratory values in patients with NASH
Study Start Date
November 4, 2020 (Actual)
Primary Completion Date
April 5, 2021 (Actual)
Study Completion Date
April 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcept Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis (NASH)
Keywords
Nonalcoholic Steatohepatitis, NASH, Nonalcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Miricorilant- 900 mg
Arm Type
Experimental
Arm Description
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
Arm Title
Miricorilant- 600 mg
Arm Type
Experimental
Arm Description
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 6 placebo tablets orally once daily.
Intervention Type
Drug
Intervention Name(s)
Miricorilant
Other Intervention Name(s)
CORT118335
Intervention Description
Tablets taken orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets
Primary Outcome Measure Information:
Title
Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction
Description
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.
Time Frame
Baseline and up to ~Day 95
Secondary Outcome Measure Information:
Title
Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF
Description
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.
Time Frame
Baseline and up to ~Day 95
Title
Change From Baseline in Aspartate Aminotransferase
Description
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.
Time Frame
Baseline and Week 6
Title
Change From Baseline in Alanine Aminotransferase
Description
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.
Time Frame
Baseline and Week 6
Title
Change From Baseline in Gamma-glutamyl Transferase
Description
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.
Time Frame
Baseline and Week 6
Title
Change From Baseline in Propeptide of Type III Collagen
Description
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.
Time Frame
Baseline and Week 6
Title
Change From Baseline in Enhanced Liver Fibrosis Score
Description
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.
Time Frame
Baseline and Week 6
Other Pre-specified Outcome Measures:
Title
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
Time Frame
Baseline and up to ~Day 95
Title
Number of Participants With Complete Resolution in Liver Fat by MRI-PDFF for Miricorilant Versus Placebo
Time Frame
Baseline and up to ~Day 95
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director
Organizational Affiliation
Corcept Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Site 207
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Site 208
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Site 209
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Site 227
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Site 214
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Site 233
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Site 234
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Site 210
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Facility Name
Site 228
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
61434
Country
United States
Facility Name
Site 232
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Site 211
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Site 213
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Site 215
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Site 212
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site 226
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.corcept.com/wp-content/uploads/sites/3/2021/11/AASLD2021-poster-11102021-updated.pdf
Description
Poster #:LP34
Learn more about this trial
Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)
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