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A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181 in Subjects With Phenylketonuria

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 4 to 5 Eligibility criteria expanded, about 13 words · Secondary endpoints: details revised at 2 of 7 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 7 entries
  2. 2 versions Re-verified since Jul 29, 2026, no change to tracked fieldsv9-v10
  3. Study sites: 2 to 4v8
  4. Study sites: 1 to 2 Start date: Apr 21, 2026 to Apr 17, 2026v7 Show 1 more changeShow less
    • Start date: Apr 21, 2026 to Apr 17, 2026
  5. Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of Mar 2026 to Apr 21, 2026v6 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2026 to Apr 21, 2026
Show 4 earlier versionsHide 4 earlier versions
  1. 2 versions Re-verified since Feb 27, 2026, no change to tracked fieldsv4-v5
  2. Primary endpoint revised Study title revisedv3 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary purpose of this study is to assess the safety and tolerability of AG-181 in subjects with Phenylketonuria (PKU).
Trial Details
NCT Number NCT07241234
Lead Sponsor Agios Pharmaceuticals, Inc.
Conditions Phenylketonuria
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov