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Clinical Trials in India / NCT06108219
Active, not recruiting Phase 2

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

NCT06108219 · tracked via the Priya Life Science India tracker
Sponsor
Corcept Therapeutics
Phase
Phase 2
Started
2023-10-25
Last updated
2026-05-08

Condition(s) studied

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

Investigational drug(s) / intervention(s)

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)

Trial sites (77)

FacilityCityRegionStatus
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.

Other trials for the same condition

Official registry record

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.

View NCT06108219 on ClinicalTrials.gov ↗ ← All trials in India