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

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108219
• Other study ID #: CORT118335-862
• Status: Recruiting
• Phase: Phase 2
• Start date: October 25, 2023
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Corcept Therapeutics
• Contact: Clinical Trial Lead Kaur
• Phone: 650-688-2858
• Email: monarch[@]corcept.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Approximately 150 patients who are eligible for participation in the study will be randomized on Day 1 in a 2:1 ratio to 100 mg miricorilant or placebo twice weekly, for 48 weeks of treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

• AST > 17 U/L for women and AST > 20 U/L for men.

• FibroScan® liver stiffness measurement = 8 kPa and CAP = 300 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 3 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 6 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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis (NASH)

Intervention

Drug:
• Miricorilant
Miricorilant 100 mg for oral dosing
• Placebo
Matching placebo for oral dosing

Locations

Country	Name	City	State
Puerto Rico	Site #457	San Juan
United States	Site #211	Austin	Texas
United States	Site #447	Beavercreek	Ohio
United States	Site #452	Boca Raton	Florida
United States	Site #432	Brownsville	Texas
United States	Site #207	Chandler	Arizona
United States	Site #461	Cordova	Tennessee
United States	Site #370	Dallas	Texas
United States	Site #448	Dayton	Ohio
United States	Site #445	East Syracuse	New York
United States	Site #213	Edinburg	Texas
United States	Site #215	Edinburg	Texas
United States	Site #431	Georgetown	Texas
United States	Site #465	Hallandale Beach	Florida
United States	Site #430	Hialeah Gardens	Florida
United States	Site #453	Houma	Louisiana
United States	Site #305	Houston	Texas
United States	Site #378	Huntington Park	California
United States	Site #455	Jackson	New Jersey
United States	Site #228	Kansas City	Missouri
United States	Site #459	Katy	Texas
United States	Site #458	Lakewood Ranch	Florida
United States	Site #439	Lancaster	California
United States	Site #469	Long Beach	California
United States	Site #373	Los Angeles	California
United States	Site #463	Manassas	Virginia
United States	Site #451	Marrero	Louisiana
United States	Site #061	Metairie	Louisiana
United States	Site #438	Miami Lakes	Florida
United States	Site #464	Morehead City	North Carolina
United States	Site #454	New York	New York
United States	Site #214	Panorama City	California
United States	Site #440	Rockville	Maryland
United States	Site #442	Saint Paul	Minnesota
United States	Site #212	San Antonio	Texas
United States	Site #433	San Antonio	Texas
United States	Site #233	Santa Ana	California
United States	Site #226	Seattle	Washington
United States	Site #209	Tucson	Arizona
United States	Site #460	Viera	Florida
United States	Site #434	Waco	Texas
United States	Site #441	West Jordan	Utah
United States	Site #437	Westlake	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent relative change from Baseline in liver-fat content assessed by MRI-PDFF.		Week 24
Secondary	Change in liver stiffness and Controlled Attenuation Parameter (CAP) by FibroScan.		Week 24 and 48
Secondary	Change in absolute body weight		Week 24 and 48
Secondary	Change in lipids - total cholesterol, HDL, LDL, VLDL, TG, serum free fatty acids, apolipoproteins		Week 24 and 48
Secondary	Change in Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)		Week 24 and 48
Secondary	Change in ELF, Pro-C3 and other markers of liver fibrosis		Week 24 and 48
Secondary	Change in HbA1c		Week 24 and 48
Secondary	Change in HOMA-IR		Week 24 and 48
Secondary	Change in plasma glucose		Week 24 and 48
Secondary	Percent relative change from Baseline in liver-fat content by MRI-PDFF.		Week 6, Week 48
Secondary	Absolute change from Baseline in liver-fat content by MRI-PDFF.		Week 6, 24, Week 48
Secondary	Resolution of steatohepatitis (defined as a ballooning grade of 0 and a lobular inflammation grade of = 1) and no worsening of liver fibrosis at Week 48 assessed by biopsy.		Week 48
Secondary	Proportion of patients with at least 2 points reduction from Baseline in the NAS (NAFLD activity score) without worsening of liver fibrosis at Week 48 assessed by biopsy, with at least a 1-point reduction in ballooning or inflammation.		Week 48
Secondary	Improvement in liver fibrosis stage by at least 1-point (NASH CRN fibrosis score) from Baseline and no worsening of steatohepatitis at Week 48 assessed by biopsy.		Week 48