A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)

March 1, 2024 updated by: Corcept Therapeutics

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients with Nonalcoholic Steatohepatitis (MONARCH)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Approximately 150 patients who are eligible for participation in the study will be randomized on Day 1 in a 2:1 ratio to 100 mg miricorilant or placebo twice weekly, for 48 weeks of treatment.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927-4807
        • Recruiting
        • Site #457
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Site #207
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Site #209
    • California
      • Huntington Park, California, United States, 90255
        • Recruiting
        • Site #378
      • Lancaster, California, United States, 93534
        • Recruiting
        • Site #439
      • Los Angeles, California, United States, 90056
        • Recruiting
        • Site #373
      • Panorama City, California, United States, 91402
        • Recruiting
        • Site #214
      • Santa Ana, California, United States, 92704
        • Recruiting
        • Site #233
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Recruiting
        • Site #452
      • Hallandale Beach, Florida, United States, 33009
        • Recruiting
        • Site #465
      • Hialeah Gardens, Florida, United States, 33016
        • Recruiting
        • Site #430
      • Lakewood Ranch, Florida, United States, 38018
        • Not yet recruiting
        • Site #458
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Site #438
      • Viera, Florida, United States, 32940
        • Recruiting
        • Site #460
    • Louisiana
      • Houma, Louisiana, United States, 70363
        • Not yet recruiting
        • Site #453
      • Marrero, Louisiana, United States, 70072
        • Not yet recruiting
        • Site #451
    • Maryland
      • Rockville, Maryland, United States, 20854
        • Recruiting
        • Site #440
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
        • Recruiting
        • Site #442
    • Mississippi
      • Biloxi, Mississippi, United States, 39532
        • Not yet recruiting
        • Site #449
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Not yet recruiting
        • Site #228
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Not yet recruiting
        • Site #462
    • New Jersey
      • Jackson, New Jersey, United States, 08724
        • Recruiting
        • Site #455
    • New York
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Site #445
      • New York, New York, United States, 10033
        • Not yet recruiting
        • Site #454
    • North Carolina
      • Morehead City, North Carolina, United States, 29557
        • Recruiting
        • Site #464
    • Ohio
      • Beavercreek, Ohio, United States, 45440
        • Recruiting
        • Site #447
      • Dayton, Ohio, United States, 45145
        • Recruiting
        • Site #448
      • Westlake, Ohio, United States, 44145
        • Recruiting
        • Site #437
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Site #461
    • Texas
      • Austin, Texas, United States, 78757
        • Recruiting
        • Site #211
      • Brownsville, Texas, United States, 78520
        • Recruiting
        • Site #432
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • Site #213
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • Site #215
      • Georgetown, Texas, United States, 78626
        • Recruiting
        • Site #431
      • Houston, Texas, United States, 77079
        • Recruiting
        • Site #305
      • Katy, Texas, United States, 77494
        • Recruiting
        • Site #459
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Site #212
      • San Antonio, Texas, United States, 78125
        • Recruiting
        • Site #433
      • Waco, Texas, United States, 78125
        • Recruiting
        • Site #434
    • Utah
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • Site #441
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Not yet recruiting
        • Site #463
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Site #226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histological diagnosis of NASH/MASH with NAS ≥ 4 (≥ 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH-CRN fibrosis score of 2 or 3 based on the consensus method of histological assessment. A historical liver biopsy within 6 months of Screening with reading confirmed during the Screening period by a consensus panel is acceptable.
  • AST > 17 U/L for women and AST > 20 U/L for men.
  • FibroScan® liver stiffness measurement ≥ 8 kPa and CAP ≥ 300 dB/m.
  • MRI-PDFF with ≥ 8% steatosis

  • Presence of at least 1 of the following metabolic syndromes that increase the risk of NASH/MASH:

    1. Diagnosis of type 2 diabetes OR
    2. Presence of 3 or more components of metabolic syndrome:

    i. Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose ii. Systolic blood pressure ≥ 130mmHg, diastolic blood pressure ≥ 85mmHg, or treatment for hypertension iii. Serum triglycerides ≥ 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides iv. Serum high-density lipoprotein (HDL) cholesterol < 40 mg/dL (1 mmol/L) in men and < 50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL v. Overweight or obese (body mass index [BMI] ≥ 25 kg/m2 [BMI ≥ 23 kg/m2 in Asians]), or increased waist circumference ≥ 102 cm (40 in) in men and ≥ 88 cm (35 in) in women (male ≥ 90 cm [35.4 in]; women ≥ 80 cm [31.5 in] in

  • Other inclusion criteria may apply

Exclusion Criteria:

  • Have participated in another clinical trial within the last 6 months of Screening where the patient received active treatment for NASH/MASH.
  • Have participated in a clinical trial for any other indication within the last 3 months or 5 half-lives of the treatment, whichever is longer.
  • Are pregnant or lactating women
  • Have a BMI < 18 kg/m2 or > 45 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.
  • Are pregnant or lactating women
  • Have a BMI < 18 kg/m2 or > 45 kg/m2
  • Have had successful weight-loss surgery within 2 years prior to Screening or are planning weight-loss surgery during the study.
  • Have a >5% weight change within 3 months prior to Screening.
  • Have significant alcohol consumption of more than 20 g per day for women and 30 g per day for men within 1 year prior to screening or score of ≥8 on AUDIT questionnaire
  • Have any other chronic liver disease
  • History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation
  • Have hepatic decompensation
  • Other exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Patients who meet the entry criteria for study CORT118335-862 will be enrolled to receive 100 mg of miricorilant, twice a week for 48 weeks.
Drug: Miricorilant
Miricorilant 100 mg for oral dosing
Other Names:
  • CORT118335
Placebo Comparator: Placebo
Patients who meet the entry criteria for study CORT118335-862 will be enrolled to receive a matching placebo twice a week for 48 weeks.
Drug: Placebo
Matching placebo for oral dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent relative change from Baseline in liver-fat content assessed by MRI-PDFF.
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in liver stiffness and Controlled Attenuation Parameter (CAP) by FibroScan.
Time Frame: Week 24 and 48
Week 24 and 48
Change in absolute body weight
Time Frame: Week 24 and 48
Week 24 and 48
Change in lipids - total cholesterol, HDL, LDL, VLDL, TG, serum free fatty acids, apolipoproteins
Time Frame: Week 24 and 48
Week 24 and 48
Change in Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)
Time Frame: Week 24 and 48
Week 24 and 48
Change in ELF, Pro-C3 and other markers of liver fibrosis
Time Frame: Week 24 and 48
Week 24 and 48
Change in HbA1c
Time Frame: Week 24 and 48
Week 24 and 48
Change in HOMA-IR
Time Frame: Week 24 and 48
Week 24 and 48
Change in plasma glucose
Time Frame: Week 24 and 48
Week 24 and 48
Percent relative change from Baseline in liver-fat content by MRI-PDFF.
Time Frame: Week 6, Week 48
Week 6, Week 48
Absolute change from Baseline in liver-fat content by MRI-PDFF.
Time Frame: Week 6, 24, Week 48
Week 6, 24, Week 48
Resolution of steatohepatitis (defined as a ballooning grade of 0 and a lobular inflammation grade of ≤ 1) and no worsening of liver fibrosis at Week 48 assessed by biopsy.
Time Frame: Week 48
Week 48
Proportion of patients with at least 2 points reduction from Baseline in the NAS (NAFLD activity score) without worsening of liver fibrosis at Week 48 assessed by biopsy, with at least a 1-point reduction in ballooning or inflammation.
Time Frame: Week 48
Week 48
Improvement in liver fibrosis stage by at least 1-point (NASH CRN fibrosis score) from Baseline and no worsening of steatohepatitis at Week 48 assessed by biopsy.
Time Frame: Week 48
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corcept Therapeutics

Investigators

  • Study Director: Kavita Juneja, MD, Corcept Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CORT118335-862

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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