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

NCT06108219 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: CORT118335-862
• Study Type: interventional
• Target: 175
• Locations: 3 countries
• Sites: 77

Brief Summary

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent relative change from Baseline in liver-fat content assessed by MRI-PDFF (Cohort A and Cohort B)

  Week 24

Secondary Outcomes (13)

• Change in liver stiffness and Controlled Attenuation Parameter (CAP) by FibroScan. (Cohort A and Cohort B at Week 24, Cohort A at Week 48)

  Week 24 and 48

• Change in absolute body weight (Cohort A and B at Week 24, Cohort A at Week 48)

  Week 24 and 48

• Change in lipids - total cholesterol, HDL, LDL, VLDL, TG, serum free fatty acids, apolipoproteins (Cohort A and Cohort B at Week 24, Cohort A at Week 48)

  Week 24 and 48

• Change in Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) (Cohort A and Cohort B at Week 6 and 24, Cohort A at Week 48)

  Week 6, 24 and 48

• Change in ELF, Pro-C3 and other markers of liver fibrosis (Cohort A and B at Week 24, Cohort A at Week 48)

  Week 24 and 48

Study Arms (4)

Experimental (Cohort A)

EXPERIMENTAL

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.

Drug: Miricorilant (Cohort A)

Placebo (Cohort A)

PLACEBO COMPARATOR

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.

Drug: Placebo (Cohort A)

Placebo (Cohort B)

PLACEBO COMPARATOR

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.

Drug: Placebo (Cohort B)

Experimental (Cohort B)

EXPERIMENTAL

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.

Drug: Miricorilant (Cohort B)

Interventions

Miricorilant (Cohort A) DRUG

Miricorilant 100 mg for oral dosing

Also known as: CORT118335

Experimental (Cohort A)

Placebo (Cohort A) DRUG

Matching placebo for oral dosing for 48 Weeks

Placebo (Cohort A)

Miricorilant (Cohort B) DRUG

Miricorilant 100 mg for oral dosing Miricorilant 200 mg for oral dosing

Also known as: CORT118335

Experimental (Cohort B)

Placebo (Cohort B) DRUG

Matching placebo for oral dosing for 24 Weeks

Placebo (Cohort B)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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

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

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (77)

Site #207

Chandler, Arizona, 85224, United States

Location

Site #209

Tucson, Arizona, 85712, United States

Location

Site #378

Huntington Park, California, 90255, United States

Location

Site #439

Lancaster, California, 93534, United States

Location

Site #469

Long Beach, California, 90815, United States

Location

Site #373

Los Angeles, California, 90056, United States

Location

Site #214

Panorama City, California, 91402, United States

Location

Site #233

Santa Ana, California, 92704, United States

Location

Site #452

Boca Raton, Florida, 33434, United States

Location

Site # 101

Gainesville, Florida, 32610, United States

Location

Site #465

Hallandale, Florida, 33009, United States

Location

Site #430

Hialeah Gardens, Florida, 33016, United States

Location

Site #458

Lakewood Rch, Florida, 38018, United States

Location

Site #475

Largo, Florida, 33777, United States

Location

Site #438

Miami Lakes, Florida, 33016, United States

Location

Site #460

Viera, Florida, 32940, United States

Location

Site #453

Houma, Louisiana, 70363, United States

Location

Site #451

Marrero, Louisiana, 70072, United States

Location

Site #061

Metairie, Louisiana, 70006, United States

Location

Site #440

Rockville, Maryland, 20854, United States

Location

Site #442

Saint Paul, Minnesota, 55114, United States

Location

Site #228

Kansas City, Missouri, 64131, United States

Location

Site #455

Jackson, New Jersey, 08724, United States

Location

Site #445

East Syracuse, New York, 13057, United States

Location

Site #454

New York, New York, 10033, United States

Location

Site #464

Morehead City, North Carolina, 29557, United States

Location

Site #447

Beavercreek, Ohio, 45440, United States

Location

Site #470

Columbus, Ohio, 43234, United States

Location

Site #448

Dayton, Ohio, 45145, United States

Location

Site #437

Westlake, Ohio, 44145, United States

Location

Site #461

Cordova, Tennessee, 38018, United States

Location

Site # 546

Arlington, Texas, 76012, United States

Location

Site #545

Austin, Texas, 78756, United States

Location

Site #211

Austin, Texas, 78757, United States

Location

Site #432

Brownsville, Texas, 78520, United States

Location

Site #370

Dallas, Texas, 75230, United States

Location

Site #213

Edinburg, Texas, 78539, United States

Location

Site #215

Edinburg, Texas, 78539, United States

Location

Site #431

Georgetown, Texas, 78626, United States

Location

Site # 066

Houston, Texas, 77030, United States

Location

Site #305

Houston, Texas, 77079, United States

Location

Site #459

Katy, Texas, 77494, United States

Location

Site #433

San Antonio, Texas, 78125, United States

Location

Site #212

San Antonio, Texas, 78229, United States

Location

Site #434

Waco, Texas, 78125, United States

Location

Site #441

West Jordan, Utah, 84088, United States

Location

Site #463

Manassas, Virginia, 20110, United States

Location

Site #226

Seattle, Washington, 98105, United States

Location

Site #506

Guwahati, Assam, 781032, India

Location

Site #492

Ahmedabad, Gujarat, 380053, India

Location

Site #513

Rajkot, Gujarat, 360001, India

Location

Site #490

Surat, Gujarat, 395009, India

Location

Site #514

Surat, Gujarat, 395009, India

Location

Site #502

Vadodara, Gujarat, 390007, India

Location

Site # 494

Rohtak, Haryana, 124001, India

Location

Site #511

Mysore, Karnataka, 570015, India

Location

Site #507

Thiruvananthapuram, Kerala, 695011, India

Location

Site #512

Mumbai, Maharashtra, 400008, India

Location

Site #509

Mumbai, Maharashtra, 400062, India

Location

Site #500

Nagpur, Maharashtra, 440009, India

Location

Site #496

Pune, Maharashtra, 412201, India

Location

Site #495

Ludhiana, Punjab, 141002, India

Location

Site #489

Jaipur, Rajasthan, 302001, India

Location

Site # 485

Jaipur, Rajasthan, 302004, India

Location

Site #508

Madurai, Tamil Nadu, 625020, India

Location

Site #486

Hyderabad, Telangana, 500003, India

Location

Site #549

Lucknow, Uttar Pradesh, 226003, India

Location

Site #488

Varanasi, Uttar Pradesh, 221005, India

Location

Site #503

Varanasi, Uttar Pradesh, 221005, India

Location

Site #504

Dehradun, Uttarakhand, 248001, India

Location

Site #487

Kolkata, West Bengal, 700020, India

Location

Site #493

Kolkata, West Bengal, 700073, India

Location

Site #491

Kolkata, West Bengal, 700150, India

Location

Site #482

New Delhi, 110029, India

Location

Site #510

New Delhi, 110060, India

Location

Site #501

New Delhi, 110070, India

Location

Site #457

San Juan, 00927-4807, Puerto Rico

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

CORT118335

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Kavita Juneja, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 30, 2023
• Study Start: October 25, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (48); PR (1); IN (28)