Trials / Active Not Recruiting
Active Not RecruitingNCT06108219
A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
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)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 175 (actual)
- Sponsor
- Corcept Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients with Nonalcoholic Steatohepatitis (MONARCH)
Detailed description
Approximately 75 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 (Cohort A). Approximately 90 patients who are eligible for participation in the study will be randomized on Day 1 in a 2:1 ratio to 100 mg miricorilant twice a week for 6 weeks of treatment, followed by a dose escalation to 200 mg miricorilant or placebo twice weekly for an additional 18 weeks which resulting in a total treatment duration of 24 weeks, or to placebo for 24 weeks. (Cohort B).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| DRUG | Placebo (Cohort B) | Matching placebo for oral dosing for 24 Weeks |
Timeline
- Start date
- 2023-10-25
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2023-10-30
- Last updated
- 2025-11-26
Locations
77 sites across 3 countries: United States, India, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06108219. Inclusion in this directory is not an endorsement.