A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
NCT ID: NCT06108219
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
175 participants
INTERVENTIONAL
2023-10-25
2026-09-30
Brief Summary
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Detailed Description
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Approximately 90 patients who are eligible for participation in the study will be randomized on Day 1 in a 2:1 ratio to 100 mg miricorilant twice a week for 6 weeks of treatment, followed by a dose escalation to 200 mg miricorilant or placebo twice weekly for an additional 18 weeks which resulting in a total treatment duration of 24 weeks, or to placebo for 24 weeks. (Cohort B).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental (Cohort A)
Patients who meet the entry criteria for study CORT118335-862 (Cohort A) will be enrolled to receive 100 mg of miricorilant, twice a week for 48 weeks.
Miricorilant (Cohort A)
Miricorilant 100 mg for oral dosing
Placebo (Cohort A)
Patients who meet the entry criteria for study CORT118335-862 (Cohort A) will be enrolled to receive a matching placebo twice a week for 48 weeks.
Placebo (Cohort A)
Matching placebo for oral dosing for 48 Weeks
Placebo (Cohort B)
Patients who meet the entry criteria for study CORT118335-862 (Cohort B) will be enrolled to receive a matching placebo twice a week for 24 weeks.
Placebo (Cohort B)
Matching placebo for oral dosing for 24 Weeks
Experimental (Cohort B)
Patients who meet the entry criteria for study CORT118335-862 (Cohort B) will be enrolled to receive 100 mg of miricorilant, twice a week for 6 weeks. Dose will be escalated to 200 mg of miricorilant, twice a week for 18 weeks.
Miricorilant (Cohort B)
Miricorilant 100 mg for oral dosing Miricorilant 200 mg for oral dosing
Interventions
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Miricorilant (Cohort A)
Miricorilant 100 mg for oral dosing
Placebo (Cohort A)
Matching placebo for oral dosing for 48 Weeks
Miricorilant (Cohort B)
Miricorilant 100 mg for oral dosing Miricorilant 200 mg for oral dosing
Placebo (Cohort B)
Matching placebo for oral dosing for 24 Weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
* NAS ≥ 3 with ≥1 point in each subcomponent of steatosis, inflammation, and ballooning, and a NASH-CRN fibrosis score of F1 or
* 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
* AST \> 17 U/L for women and AST \> 20 U/L for men.
* FibroScan® liver stiffness measurement ≥ 8 kPa and CAP ≥ 280 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 2 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Corcept Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Kavita Juneja, MD
Role: STUDY_DIRECTOR
Corcept Therapeutics
Locations
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Site #207
Chandler, Arizona, United States
Site #209
Tucson, Arizona, United States
Site #378
Huntington Park, California, United States
Site #439
Lancaster, California, United States
Site #469
Long Beach, California, United States
Site #373
Los Angeles, California, United States
Site #214
Panorama City, California, United States
Site #233
Santa Ana, California, United States
Site #452
Boca Raton, Florida, United States
Site # 101
Gainesville, Florida, United States
Site #465
Hallandale, Florida, United States
Site #430
Hialeah Gardens, Florida, United States
Site #458
Lakewood Rch, Florida, United States
Site #475
Largo, Florida, United States
Site #438
Miami Lakes, Florida, United States
Site #460
Viera, Florida, United States
Site #453
Houma, Louisiana, United States
Site #451
Marrero, Louisiana, United States
Site #061
Metairie, Louisiana, United States
Site #440
Rockville, Maryland, United States
Site #442
Saint Paul, Minnesota, United States
Site #228
Kansas City, Missouri, United States
Site #455
Jackson, New Jersey, United States
Site #445
East Syracuse, New York, United States
Site #454
New York, New York, United States
Site #464
Morehead City, North Carolina, United States
Site #447
Beavercreek, Ohio, United States
Site #470
Columbus, Ohio, United States
Site #448
Dayton, Ohio, United States
Site #437
Westlake, Ohio, United States
Site #461
Cordova, Tennessee, United States
Site # 546
Arlington, Texas, United States
Site #545
Austin, Texas, United States
Site #211
Austin, Texas, United States
Site #432
Brownsville, Texas, United States
Site #370
Dallas, Texas, United States
Site #213
Edinburg, Texas, United States
Site #215
Edinburg, Texas, United States
Site #431
Georgetown, Texas, United States
Site # 066
Houston, Texas, United States
Site #305
Houston, Texas, United States
Site #459
Katy, Texas, United States
Site #433
San Antonio, Texas, United States
Site #212
San Antonio, Texas, United States
Site #434
Waco, Texas, United States
Site #441
West Jordan, Utah, United States
Site #463
Manassas, Virginia, United States
Site #226
Seattle, Washington, United States
Site #506
Guwahati, Assam, India
Site #492
Ahmedabad, Gujarat, India
Site #513
Rajkot, Gujarat, India
Site #490
Surat, Gujarat, India
Site #514
Surat, Gujarat, India
Site #502
Vadodara, Gujarat, India
Site # 494
Rohtak, Haryana, India
Site #511
Mysore, Karnataka, India
Site #507
Thiruvananthapuram, Kerala, India
Site #512
Mumbai, Maharashtra, India
Site #509
Mumbai, Maharashtra, India
Site #500
Nagpur, Maharashtra, India
Site #496
Pune, Maharashtra, India
Site #495
Ludhiana, Punjab, India
Site #489
Jaipur, Rajasthan, India
Site # 485
Jaipur, Rajasthan, India
Site #508
Madurai, Tamil Nadu, India
Site #486
Hyderabad, Telangana, India
Site #549
Lucknow, Uttar Pradesh, India
Site #488
Varanasi, Uttar Pradesh, India
Site #503
Varanasi, Uttar Pradesh, India
Site #504
Dehradun, Uttarakhand, India
Site #487
Kolkata, West Bengal, India
Site #493
Kolkata, West Bengal, India
Site #491
Kolkata, West Bengal, India
Site #482
New Delhi, , India
Site #510
New Delhi, , India
Site #501
New Delhi, , India
Site #457
San Juan, , Puerto Rico
Countries
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Other Identifiers
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CORT118335-862
Identifier Type: -
Identifier Source: org_study_id
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