A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
Miricorilant (Cohort A)Placebo (Cohort A)Miricorilant (Cohort B)Placebo (Cohort B)
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
Study summary
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients with Nonalcoholic Steatohepatitis (MONARCH)
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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:
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
* Other inclusion criteria may apply
Exclusion Criteria:
* 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
Primary outcome measure(s)
Percent relative change from Baseline in liver-fat content assessed by MRI-PDFF (Cohort A and Cohort B) — Week 24
Trial sites (77)
Facility
City
Region
Status
Site #207
Chandler
Arizona
Site #209
Tucson
Arizona
Site #378
Huntington Park
California
Site #439
Lancaster
California
Site #469
Long Beach
California
Site #373
Los Angeles
California
Site #214
Panorama City
California
Site #233
Santa Ana
California
Site #452
Boca Raton
Florida
Site # 101
Gainesville
Florida
Site #465
Hallandale
Florida
Site #430
Hialeah Gardens
Florida
Site #458
Lakewood Rch
Florida
Site #475
Largo
Florida
Site #438
Miami Lakes
Florida
Site #460
Viera
Florida
Site #453
Houma
Louisiana
Site #451
Marrero
Louisiana
Site #061
Metairie
Louisiana
Site #440
Rockville
Maryland
Site #442
Saint Paul
Minnesota
Site #228
Kansas City
Missouri
Site #455
Jackson
New Jersey
Site #445
East Syracuse
New York
Site #454
New York
New York
Site #464
Morehead City
North Carolina
Site #447
Beavercreek
Ohio
Site #470
Columbus
Ohio
Site #448
Dayton
Ohio
Site #437
Westlake
Ohio
Site #461
Cordova
Tennessee
Site # 546
Arlington
Texas
Site #545
Austin
Texas
Site #211
Austin
Texas
Site #432
Brownsville
Texas
Site #370
Dallas
Texas
Site #213
Edinburg
Texas
Site #215
Edinburg
Texas
Site #431
Georgetown
Texas
Site # 066
Houston
Texas
+ 37 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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