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

Primary Purpose

Nonalcoholic Steatohepatitis (NASH)

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Miricorilant 150 mg
Miricorilant 100 mg
Miricorilant 50 mg
Miricorilant 10 mg
Sponsored by
Corcept Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 207
  • Site 209Recruiting
  • Site 214Recruiting
  • Site 233Recruiting
  • Site 210
  • Site 211Recruiting
  • Site 213
  • Site 305Recruiting
  • Site 212Recruiting
  • 226Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1 - 150 mg of miricorilant for 24 weeks

Cohort 2 - 150 mg of miricorilant for 12 weeks

Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks

Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks

Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks

Cohort 6 - 100 mg of miricorilant every MF for 12 weeks

Cohort 7 - 50 mg of miricorilant daily for 12 weeks

Cohort 8 - 100 mg of miricorilant daily for 12 weeks

Cohort 9 - 30 mg of miricorilant daily for 12 weeks

Cohort 10 - 200 mg of miricorilant once a week for 12 weeks

Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeks

Arm Description

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 24 weeks.

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 12 weeks.

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily for 2 weeks, followed by 100 mg of miricorilant every Monday, Wednesday and Friday for 10 weeks.

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 2 weeks, followed by 100 mg of miricorilant every Monday and Friday for 10 weeks.

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday, Wednesday and Friday for 12 weeks.

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday and Friday for 12 weeks.

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 50 mg once daily, for 12 weeks.

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 12 weeks.

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 30 mg once daily, for 12 weeks.

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 200 mg once weekly, for 12 weeks.

Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg twice weekly for 12 weeks.

Outcomes

Primary Outcome Measures

Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.

Secondary Outcome Measures

Change from Baseline in aspartate aminotransferase (AST).
Change from Baseline in alanine aminotransferase (ALT).
Change from Baseline in gamma-glutamyl transferase (GGT).
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.

Full Information

First Posted
October 12, 2021
Last Updated
September 28, 2023
Sponsor
Corcept Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05117489
Brief Title
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
Official Title
A Phase 1b, Open-Label Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Adult Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

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
No

5. Study Description

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

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 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 - 150 mg of miricorilant for 24 weeks
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 24 weeks.
Arm Title
Cohort 2 - 150 mg of miricorilant for 12 weeks
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg once daily, for 12 weeks.
Arm Title
Cohort 3 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MWF for 10 weeks
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily for 2 weeks, followed by 100 mg of miricorilant every Monday, Wednesday and Friday for 10 weeks.
Arm Title
Cohort 4 - 100 mg daily miricorilant for 2 weeks, followed by 100 mg every MF for 10 weeks
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 2 weeks, followed by 100 mg of miricorilant every Monday and Friday for 10 weeks.
Arm Title
Cohort 5 - 100 mg of miricorilant every MWF for 12 weeks
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday, Wednesday and Friday for 12 weeks.
Arm Title
Cohort 6 - 100 mg of miricorilant every MF for 12 weeks
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant of 100 mg every Monday and Friday for 12 weeks.
Arm Title
Cohort 7 - 50 mg of miricorilant daily for 12 weeks
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 50 mg once daily, for 12 weeks.
Arm Title
Cohort 8 - 100 mg of miricorilant daily for 12 weeks
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 100 mg once daily, for 12 weeks.
Arm Title
Cohort 9 - 30 mg of miricorilant daily for 12 weeks
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 30 mg once daily, for 12 weeks.
Arm Title
Cohort 10 - 200 mg of miricorilant once a week for 12 weeks
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 200 mg once weekly, for 12 weeks.
Arm Title
Cohort 11 - 150 mg of miricorilant twice weekly for 12 weeks
Arm Type
Experimental
Arm Description
Patients who meet the entry criteria for study CORT-118335-861 will be enrolled to receive miricorilant as a steady dose of 150 mg twice weekly for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Miricorilant 150 mg
Other Intervention Name(s)
CORT118335
Intervention Description
Miricorilant 150 mg for oral dosing
Intervention Type
Drug
Intervention Name(s)
Miricorilant 100 mg
Other Intervention Name(s)
CORT118335
Intervention Description
Miricorilant 100 mg for oral dosing
Intervention Type
Drug
Intervention Name(s)
Miricorilant 50 mg
Other Intervention Name(s)
CORT118335
Intervention Description
Miricorilant 50 mg for oral dosing
Intervention Type
Drug
Intervention Name(s)
Miricorilant 10 mg
Other Intervention Name(s)
CORT118335
Intervention Description
Miricorilant 10 mg for oral dosing.
Primary Outcome Measure Information:
Title
Relative change from Baseline in liver-fat content assessed by MRI-PDFF compared to Baseline.
Time Frame
Baseline Day 1 up to Week 24
Secondary Outcome Measure Information:
Title
Change from Baseline in aspartate aminotransferase (AST).
Time Frame
Baseline Day 1 up to Week 24
Title
Change from Baseline in alanine aminotransferase (ALT).
Time Frame
Baseline Day 1 up to Week 24
Title
Change from Baseline in gamma-glutamyl transferase (GGT).
Time Frame
Baseline Day 1 up to Week 24
Title
Change from baseline in enhanced liver fibrosis score (ELF).
Description
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.
Time Frame
Baseline Day 1 up to Week 24

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/m2 Have had liver transplantation or plan to have liver transplantation during the study Have type 1 diabetes or poorly controlled type 2 diabetes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Lead
Phone
650-327-3270
Email
Study861ctgov@corcept.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kavita Juneja, MD
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
Individual Site Status
Active, not recruiting
Facility Name
Site 209
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 214
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 233
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 210
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Individual Site Status
Withdrawn
Facility Name
Site 211
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 213
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Site 305
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Individual Site Status
Recruiting
Facility Name
Site 212
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
226
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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