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Phase 2 Study to Assess the Safety and Efficacy of ANG003

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Site details revised at 2 of 27 sites
  2. Minor Site details revised at 1 of 27 sites
  3. Minor Study sites: 26 to 27 Eligibility criteria expanded, about 11 words · Secondary endpoints: details revised at 1 of 5 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 5 entries
  4. Minor Site details revised at 1 of 26 sitesv11
  5. Minor Site details revised at 3 of 26 sitesv10
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Site details revised at 1 of 26 sitesv9
  2. Minor Site details revised at 3 of 26 sitesv8
  3. Minor Site details revised at 1 of 26 sitesv7
  4. Minor Site details revised at 1 of 26 sitesv6
  5. Minor Site details revised at 1 of 26 sitesv5
  6. Minor Site details revised at 1 of 26 sitesv4
  7. Minor Site details revised at 2 of 26 sitesv3
  1. Notable Recruitment opened Trial sites expanded: 0 → 26 locations · Start date changed from estimate of Apr 2026 to Apr 24, 2026v2 Show 2 more changesShow less
    • Trial sites expanded: 0 → 26 locations
    • Start date changed from estimate of Apr 2026 to Apr 24, 2026
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In this study, ANG003, a pancreatic enzyme replacement therapy (PERT; commonly called "enzymes"), is being investigated as a potential treatment for exocrine pancreatic insufficiency (EPI). People with EPI due to Cystic Fibrosis (CF) may be eligible to participate in this study. The primary objective of this study is to evaluate the safety of ANG003 and see if it works as well compared to Creon, an approved PERT.
Trial Details
NCT Number NCT07450547
Lead Sponsor Anagram Therapeutics, Inc.
Conditions Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
Enrollment 113 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov