A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
← catalyst calendarNCT06108219 · readout ≤ 42 d
Sponsored by Corcept Therapeutics (industry) · CORT — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
175actual
Sites
77
Countries
India, Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-10-25 | actual | When the study began enrolling |
| Primary completion | Sep 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Metabolic Dysfunction-associated Steatohepatitis (MASH)
Interventions
- Drug: Miricorilant (Cohort A) — also filed as CORT118335
- Drug: Placebo (Cohort A)
- Drug: Miricorilant (Cohort B) — also filed as CORT118335
- Drug: Placebo (Cohort B)
Primary outcome
what the primary-completion date above is the date OFPercent relative change from Baseline in liver-fat content assessed by MRI-PDFF (Cohort A and Cohort B)
measured Week 24
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