MZE782 in adults with phenylketonuria (PKU) testing safety and efficacy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial evaluating MZE782 in adults aged 18 to 75 with phenylketonuria. Participants receive MZE782 or placebo to assess safety, tolerability, and signs of efficacy while maintaining or adjusting dietary/protein intake as specified. Some groups may require stopping certain PKU medications or meeting specific blood phenylalanine level criteria. The study is conducted at select U.S. sites and is sponsored by Maze Therapeutics, with coordination across multiple academic centers. Eligible participants will have PKU confirmed by diagnosis and must meet predefined inclusion and exclusion criteria to ensure safe and interpretable results.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Males and females 18 to 75 years old
* Confirmed diagnosis of PKU
* Willing and able to keep diet and protein intake consistent during the study
* For some study groups, is willing and able to stop certain PKU medications before starting study treatment
* For some study groups, may need to meet additional blood phenylalanine level or background-treatment requirements
* Meets minimum blood phenylalanine level requirements for study group

Key Exclusion Criteria:

* Is pregnant, breastfeeding, or planning to become pregnant or conceive a child during the study
* Medical conditions or abnormal test results that could make participation unsafe or make it difficult to complete study procedures or interpret study results
* Has recently received another investigational drug
* Is unable to swallow tablets or tolerate oral medication

Other inclusion/exclusion criteria defined in protocol apply.

Where it's running

• UCSF Benioff Children's Hospital Oakland
  Oakland, California, United States Recruiting
• Stanford University Clinical and Translational Research Unit
  Palo Alto, California, United States Recruiting
• Ann and Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• Indiana University School of Medicine
  Indianapolis, Indiana, United States Recruiting
• University of Kentucky Medical Center
  Lexington, Kentucky, United States Recruiting
• Clinic for Special Children
  Gordonville, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Maze Therapeutics
• Email: medicalinfo@mazetx.com
• Phone: 650-850-5075

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.