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A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 3, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later May 15, 2025 → Sep 30, 2026
Primary endpoints added 8 → 12 primary endpoints
See other at-risk trials from Inipharm Australia Pty Ltd

Record History

  1. Primary completion pushed from May 15, 2025 to Sep 30, 2026 Primary endpoint(s) modified · Enrollment increased: 104 → 168 participants · Trial sites expanded: 7 → 11 locations · 5 morev6 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 104 → 168 participants
    • Trial sites expanded: 7 → 11 locations
    • Completion pushed from Jun 15, 2025 to Oct 31, 2026
    • Eligibility criteria expanded, about 666 words
    • Secondary endpoints: 3 to 6
    • Study description expanded, about 186 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Nov 15, 2024 to May 15, 2025 Enrollment target: 96 to 104 · Completion date: Dec 15, 2024 to Jun 15, 2025 · Eligibility criteria expanded, about 68 words · 2 morev5 Show 5 more changesShow less
    • Enrollment target: 96 to 104
    • Completion date: Dec 15, 2024 to Jun 15, 2025
    • Eligibility criteria expanded, about 68 words
    • Study description expanded, about 20 words
    • Site details revised at 6 of 7 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 1 to 7 Primary completion date: May 20, 2024 to Nov 15, 2024 · Completion date: Jul 28, 2024 to Dec 15, 2024 · Eligibility criteria expanded, about 449 wordsv4 Show 3 more changesShow less
    • Primary completion date: May 20, 2024 to Nov 15, 2024
    • Completion date: Jul 28, 2024 to Dec 15, 2024
    • Eligibility criteria expanded, about 449 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study site revisedv3 See this version in full on ClinicalTrials.gov ↗
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jul 20, 2023 to Sep 8, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 20, 2023 to Sep 8, 2023
  6. 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.
This Phase 1 trial will explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of INI-822 in healthy volunteers in Parts A, B, D and F and in participants with a history of MASH or presumed MASH in Part C and in participants with MASH in E.
Trial Details
NCT Number NCT05945537
Lead Sponsor Inipharm Australia Pty Ltd
Conditions Metabolic Dysfunction-Associated Steatohepatitis
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov