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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823703
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

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).

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis (NASH) Drug: Miricorilant Drug: Placebo Phase 2

Detailed Description:

This is a randomized, double-blind, placebo-controlled study that 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 CORT118335-860 will be randomized on Day 1 to receive 900 mg miricorilant, 600 mg miricorilant, or placebo for 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Subject, Investigator and Outcomes Assessor
Primary Purpose: Treatment
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)
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Miricorilant- 900 mg
Patients who meet the entry criteria for the Study CORT118335-860 will be randomized to receive 900 mg miricorilant once daily for 12 weeks.
Drug: Miricorilant
Miricorilant 900 mg for oral dosing
Other Name: CORT118335

Experimental: Miricorilant- 600 mg
Patients who meet the entry criteria for the Study CORT118335-860 will be randomized to receive 600 mg miricorilant plus placebo once daily for 12 weeks.
Drug: Miricorilant
Miricorilant 600 mg for oral dosing
Other Name: CORT118335

Drug: Placebo
Placebo tablets for oral dosing

Placebo Comparator: Placebo
Patients who meet the entry criteria for the Study CORT118335-860 will be randomized to receive placebo once daily for 12 weeks.
Drug: Placebo
Placebo tablets for oral dosing




Primary Outcome Measures :
  1. Relative change from Baseline in LFC (liver fat content) assessed by MRI-PDFF. [ Time Frame: Baseline Day 1 to Week 12 ]

Secondary Outcome Measures :
  1. Proportion of patients achieving a relative reduction in LFC of ≥30% by MRI-PDFF [ Time Frame: Baseline Day 1 to week 12 ]
  2. Change from Baseline in propeptide of type III collagen (pro-C3) [ Time Frame: Baseline Day 1 to week 12 ]
  3. Change from Baseline in enhanced liver fibrosis (ELF) score and its components (hyaluronic acid, tissue inhibitor of metalloproteinases-1 [TIMP-1], type III procollagen [PIIINP]) [ Time Frame: Baseline Day 1 to Week 12 ]
  4. Change from Baseline in aspartate aminotransferase (AST) [ Time Frame: Baseline Day 1 to Week 12 ]
  5. Change from Baseline in alanine aminotransferase (ALT) [ Time Frame: Baseline Day 1 to Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823703


Contacts
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Contact: Clinical Trial Lead 650-327-3270 study860ct.gov@corcept.com

Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Study Director: Ada Lee, MD Corcept Therapeutics
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Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT03823703    
Other Study ID Numbers: CORT118335-860
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corcept Therapeutics:
Nonalcoholic Steatohepatitis
NASH
Nonalcoholic Fatty Liver Disease
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Cortisone
Anti-Inflammatory Agents