Phase 2 Phenylketonuria Trial, Recruiting NCT07694440 Sponsor: Maze Therapeutics Condition: Phenylketonuria
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Phase 2 Phenylketonuria Trial, Recruiting

NCT07694440
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 to 75 years, of any gender, may be considered for this trial
  • People who have been clinically diagnosed with PKU (phenylketonuria) may be eligible
  • Participants must be willing and able to keep their diet and protein intake consistent throughout the study
  • For certain study groups, participants may need to be willing and able to stop certain PKU medications before the study treatment begins
  • For certain study groups, additional requirements around blood phenylalanine levels or current background treatments may apply (confirm with trial site)
  • Blood phenylalanine levels must meet a minimum threshold for the relevant study group (confirm with trial site)

Who may not be able to join:

  • People who are pregnant, breastfeeding, planning to become pregnant, or planning to father a child during the study or within 90 days after the last dose may not be eligible
  • People with certain medical conditions or abnormal test results that could make participation unsafe, or that could interfere with completing study procedures or interpreting results, may not be eligible
  • People who have recently received another investigational (experimental) drug may not be eligible
  • People who are unable to swallow tablets or tolerate medication taken by mouth may not be eligible

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Medical Director, Maze Therapeutics

Phone: 650-850-5075

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Maze Therapeutics
Registry
ClinicalTrials.gov
Start date
23 June 2026
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and tolerability based on incidence of adverse events (AEs); For Cohorts 1A and 1B: Absolute change in plasma Phe levels from Baseline to the mean of plasma Phe levels

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov