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

NCT06108219 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2026-05-08

No results posted yet for this 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)

Conditions

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

Interventions

DRUG

Placebo (Cohort B)

Matching placebo for oral dosing for 24 Weeks

DRUG

Miricorilant (Cohort A)

Miricorilant 100 mg for oral dosing

DRUG

Placebo (Cohort A)

Matching placebo for oral dosing for 48 Weeks

DRUG

Miricorilant (Cohort B)

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

Sponsors & Collaborators

  • Corcept Therapeutics

    lead INDUSTRY

Principal Investigators

  • Kavita Juneja, MD · Corcept Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-25
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States
  • India
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06108219 on ClinicalTrials.gov