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Clinical Trials in the UK / NCT07694440
Recruiting Phase 2

A Study of MZE782 in Adults With PKU

NCT07694440 · tracked via the Priya Life Science UK tracker
Sponsor
Maze Therapeutics
Phase
Phase 2
Started
2026-06-23
Last updated
2026-10-08

Condition(s) studied

Phenylketonuria (PKU)

Investigational drug(s) / intervention(s)

MZE782PlaceboMZE782

MZE782: Tablet, Low Dose

Placebo: Tablet

MZE782: Tablet, High Dose

Study summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of MZE782 in adults with Phenylketonuria (PKU).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Safety and tolerability based on incidence of adverse events (AEs) — Week 0 to Week 17
  • For Cohorts 1A and 1B: Absolute change in plasma Phe levels from Baseline to the mean of plasma Phe levels — Baseline and Weeks 2, 3, and 4

Trial sites (7)

FacilityCityRegionStatus
UCSF Benioff Children's Hospital Oakland Oakland California Recruiting
Stanford University Clinical and Translational Research Unit Palo Alto California Recruiting
Ann and Robert H. Lurie Children's Hospital of Chicago Chicago Illinois Recruiting
Indiana University School of Medicine Indianapolis Indiana Recruiting
University of Kentucky Medical Center Lexington Kentucky Recruiting
Clinic for Special Children Gordonville Pennsylvania Recruiting
University of Tennessee Health Science Center Le Bonheur Children's Hospital Memphis Tennessee Recruiting

More Maze Therapeutics trials in the UK

A Phase 2 Study of MZE829 in Adults With APOL1 Kidney Disease Recruiting

Other trials for the same condition

PKU Microtablets Case Studies Starting soon
AAV Gene Therapy Study for Subjects with PKU Active, not recruiting
A Self-test Home-use Blood Phenylalanine Monitoring System Under the Brand Name Egoo Phe System Has Been Developed for Measurement of Phenylalanine (Phe) in Individuals Diagnosed With Phenylketonuria (PKU): The Study Purpose is to Evaluate Accuracy and Usability Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07694440 on ClinicalTrials.gov ↗ ← All trials in the UK