ACTIVE_NOT_RECRUITING

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

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Conditions

Nonalcoholic Steatohepatitis (NASH)Metabolic Dysfunction-associated Steatohepatitis (MASH)Nonalcoholic Fatty Liver Disease (NAFLD)Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2023-10-25
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06108219

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cohort A: 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.
  2. * Cohort B: Have a liver biopsy result that does not meet with the criteria for inclusion in Cohort A and is consistent with one of the following based on the consensus method of histological assessment:
  3. * NAS ≥ 3 with ≥1 point in each subcomponent of steatosis, inflammation, and ballooning, and a NASH-CRN fibrosis score of F1 or
  4. * NAS ≥ 2 with ≥1 point in subcomponent of steatosis and ≥ 1 point in subcomponent of ballooning or inflammation and a NASH-CRN fibrosis score of F2 or 3
  5. * AST \> 17 U/L for women and AST \> 20 U/L for men.
  6. * FibroScan® liver stiffness measurement ≥ 8 kPa and CAP ≥ 280 dB/m.
  7. * MRI-PDFF with ≥ 8% steatosis
  8. * Presence of at least 1 of the following metabolic syndromes that increase the risk of NASH/MASH:
  9. 1. Diagnosis of type 2 diabetes OR
  10. 2. Presence of 2 or more components of metabolic syndrome:
  11. * Other inclusion criteria may apply
  1. * Have participated in another clinical trial within the last 3 months of Screening where the patient received active treatment for NASH/MASH.
  2. * 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.
  3. * Are pregnant or lactating women
  4. * Have a BMI \< 18 kg/m2 or \> 45 kg/m2.• Have had liver transplantation or plan to have liver transplantation during the study
  5. * Have type 1 diabetes or poorly controlled type 2 diabetes.
  6. * Are pregnant or lactating women
  7. * Have a BMI \< 18 kg/m2 or \> 45 kg/m2
  8. * Have had successful weight-loss surgery within 2 years prior to Screening or are planning weight-loss surgery during the study.
  9. * Have a \>5% weight change within 3 months prior to Screening.
  10. * 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
  11. * Have any other chronic liver disease
  12. * History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation
  13. * Have hepatic decompensation
  14. * Other exclusion criteria may apply

Contacts and Locations

Principal Investigator

Kavita Juneja, MD
STUDY_DIRECTOR
Corcept Therapeutics

Study Locations (Sites)

Site #207
Chandler, Arizona, 85224
United States
Site #209
Tucson, Arizona, 85712
United States
Site #378
Huntington Park, California, 90255
United States
Site #439
Lancaster, California, 93534
United States
Site #469
Long Beach, California, 90815
United States
Site #373
Los Angeles, California, 90056
United States
Site #214
Panorama City, California, 91402
United States
Site #233
Santa Ana, California, 92704
United States
Site #452
Boca Raton, Florida, 33434
United States
Site # 101
Gainesville, Florida, 32610
United States
Site #465
Hallandale Beach, Florida, 33009
United States
Site #430
Hialeah Gardens, Florida, 33016
United States
Site #458
Lakewood Ranch, Florida, 38018
United States
Site #475
Largo, Florida, 33777
United States
Site #438
Miami Lakes, Florida, 33016
United States
Site #460
Viera, Florida, 32940
United States
Site #453
Houma, Louisiana, 70363
United States
Site #451
Marrero, Louisiana, 70072
United States
Site #061
Metairie, Louisiana, 70006
United States
Site #440
Rockville, Maryland, 20854
United States
Site #442
Saint Paul, Minnesota, 55114
United States
Site #228
Kansas City, Missouri, 64131
United States
Site #455
Jackson, New Jersey, 08724
United States
Site #445
East Syracuse, New York, 13057
United States
Site #454
New York, New York, 10033
United States
Site #464
Morehead City, North Carolina, 29557
United States
Site #447
Beavercreek, Ohio, 45440
United States
Site #470
Columbus, Ohio, 43234
United States
Site #448
Dayton, Ohio, 45145
United States
Site #437
Westlake, Ohio, 44145
United States
Site #461
Cordova, Tennessee, 38018
United States
Site # 546
Arlington, Texas, 76012
United States
Site #545
Austin, Texas, 78756
United States
Site #211
Austin, Texas, 78757
United States
Site #432
Brownsville, Texas, 78520
United States
Site #370
Dallas, Texas, 75230
United States
Site #213
Edinburg, Texas, 78539
United States
Site #215
Edinburg, Texas, 78539
United States
Site #431
Georgetown, Texas, 78626
United States
Site # 066
Houston, Texas, 77030
United States
Site #305
Houston, Texas, 77079
United States
Site #459
Katy, Texas, 77494
United States
Site #433
San Antonio, Texas, 78125
United States
Site #212
San Antonio, Texas, 78229
United States
Site #434
Waco, Texas, 78125
United States
Site #441
West Jordan, Utah, 84088
United States
Site #463
Manassas, Virginia, 20110
United States
Site #226
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Corcept Therapeutics

  • Kavita Juneja, MD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2023-10-25
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-10-25
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Nonalcoholic Steatohepatitis (NASH)
  • Nonalcoholic Fatty Liver Disease (NAFLD)
  • Metabolic dysfunction-Associated Steatohepatitis (MASH)
  • Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)

Additional Relevant MeSH Terms

  • Nonalcoholic Steatohepatitis (NASH)
  • Metabolic Dysfunction-associated Steatohepatitis (MASH)