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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-associated Steatohepatitis (MASH)

In brief

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

Key facts

Study ID: NCT06108219
Run by: Corcept Therapeutics
People needed: 175
Starts: 2023-10-25
Expected to finish: 2026-09-01
Last updated by the study team: 2026-05-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
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:
Diagnosis of type 2 diabetes OR
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
Other inclusion criteria may apply

You may not qualify if…

Have participated in another clinical trial within the last 3 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

Where it is running

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

Full record on ClinicalTrials.gov

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