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Study Evaluating the Safety, Efficacy, and Pharmacokinetics of CORT118335 in Patients With Probable 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 10, 2019
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Brief Summary:
This phase 2, double blind, placebo-controlled, randomized study is to access the safety and efficacy of CORT118335 in Patients with Probable Nonalcoholic Steatohepatitis (NASH).

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis (NASH) Drug: CORT118335 Phase 2

Detailed Description:

This is a randomized, double-blind, placebo-controlled study that will assess the safety efficacy and PK of CORT118335 in in Patients with Probable Nonalcoholic Steatohepatitis (NASH).

Patients who meet the criteria for the Study CORT118335-860 will be randomized on Day 1 to receive 600 mg CORT118335, 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 CORT118335 in Patients With Probable Nonalcoholic Steatohepatitis (NASH)
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021


Arm Intervention/treatment
Experimental: CORT118335- 600 mg
Patients who meet the entry criteria for the Study CORT118335-860 will be randomized to receive 600 mg CORT118335, or placebo for 12 weeks.
Drug: CORT118335
CORT118335 600mg, and Placebo tablets for oral dosing
Other Name: Miricorilant

Placebo Comparator: Placebo
Patients who meet the entry criteria for the Study CORT118335-860 will be randomized to receive 600 mg CORT118335, or placebo for 12 weeks.
Drug: CORT118335
CORT118335 600mg, and Placebo tablets for oral dosing
Other Name: Miricorilant




Primary Outcome Measures :
  1. Relative change from Baseline to Week 12 in LFC (Liver fat content) assessed by MRI-PDFF comparing 600 mg CORT118335 to placebo. [ Time Frame: Baseline Day 1 to Week 12 ]
  2. Incidence of TEAEs from Baseline to Week 12 and during follow-up for 600 mg CORT118335 and placebo [ Time Frame: Up to week 16 ]
  3. Changes in hematology from Baseline to Week 12 for 600 mg CORT118335 and placebo [ Time Frame: Baseline Day 1 to week 12 ]
  4. Changes in chemistry panel from Baseline to Week 12 for 600 mg CORT118335 and placebo [ Time Frame: Baseline Day 1 to week 12 ]

Secondary Outcome Measures :
  1. Proportion of patients achieving a relative reduction in LFC (Liver fat content) of ≥30% by MRI-PDFF [ Time Frame: Baseline Day 1 to week 12 ]

    LFC assessed at week 12 for 600 mg CORT118335 versus placebo

    LFC assessed at week 12 for 600 mg CORT118335 versus placebo LFC assessed at week 12 for 600 mg CORT118335 versus placebo

    LFC assessed at week 12 for 600 mg CORT118335 versus placebo


  2. Change in propeptide of type III collagen (pro-C3) [ Time Frame: Baseline Day 1 to week 12 ]
    Change in Pro-C for 600 mg CORT118335 versus placebo



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 probable NASH with fibrosis defined by blood tests and scans

Exclusion Criteria:

  • Have participated in another clinical trial within the last 6 months where patient received active treatment for NASH
  • Have participated in another clinical trial within the last 3 months
  • Are pregnant or lactating females
  • 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 study860ctgov@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 10, 2019
Last Verified: September 2019
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