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

StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fields
  2. Trial completed Primary completion date changed from estimate of Sep 2026 to Feb 13, 2026 · Study completion date changed from estimate of Sep 2026 to Aug 24, 2026 · Eligibility criteria expanded, about 17 words · 1 more Show 4 more changesShow less
    • Primary completion date changed from estimate of Sep 2026 to Feb 13, 2026
    • Study completion date changed from estimate of Sep 2026 to Aug 24, 2026
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 1 of 14 entries
  3. Secondary endpoints: 13 to 14v15 See this version in full on ClinicalTrials.gov ↗
  4. 3 versions Re-verified since Oct 14, 2025, no change to tracked fieldsv12-v14
  5. Enrollment target: estimated 195 to confirmed 175 Primary and study completion dates: Jun 2026 to Sep 2026 · Study description revisedv11 Show 2 more changesShow less
    • Primary and study completion dates: Jun 2026 to Sep 2026
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

Show 9 earlier versionsHide 9 earlier versions
  1. Re-verified, no change to tracked fieldsv10
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 45 to 77 · Primary and study completion dates: Dec 2025 to Jun 2026v9 Show 2 more changesShow less
    • Study sites: 45 to 77
    • Primary and study completion dates: Dec 2025 to Jun 2026
  3. Study sites: 44 to 45 Eligibility criteria revisedv8 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  4. Primary endpoint revised Enrollment target: 150 to 195 · Study sites: 43 to 44 · Interventions: Miricorilant (Drug), Placebo (Drug) to Miricorilant (Cohort A) (Drug), Miricorilant (Cohort B) (Drug), Placebo (Cohort A) (Drug), Placebo (Cohort B) (Drug) · 4 morev7 Show 7 more changesShow less
    • Enrollment target: 150 to 195
    • Study sites: 43 to 44
    • Interventions: Miricorilant (Drug), Placebo (Drug) to Miricorilant (Cohort A) (Drug), Miricorilant (Cohort B) (Drug), Placebo (Cohort A) (Drug), Placebo (Cohort B) (Drug)
    • Eligibility criteria expanded, about 88 words
    • Secondary endpoints revised (13)
    • Study description expanded, about 71 words
    • Study arms: 2 to 4

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 42 to 43v6
  6. Study sites: 34 to 42 Eligibility criteria expanded, about 5 words · Study title expanded, about 2 wordsv5 Show 2 more changesShow less
    • Eligibility criteria expanded, about 5 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  7. Site details revised at 4 of 34 sitesv4
  8. Study sites: 1 to 34v3
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Oct 2023 to Oct 25, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2023 to Oct 25, 2023
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT06108219
Lead Sponsor Corcept Therapeutics
Conditions Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-associated Steatohepatitis (MASH)
Enrollment 175 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov