NCT07694440PHASE2Recruiting
A Study of MZE782 in Adults With PKU
Maze Therapeutics
Start Date
6/23/2026
Completion Date
2/1/2028
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of MZE782 in adults with Phenylketonuria (PKU).
Eligibility Criteria
Age Range: 18 years to 75 years
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.
Interventions
DRUG
MZE782
OTHER
Placebo
DRUG
MZE782
Conditions
Phenylketonuria (PKU)
Locations
UCSF Benioff Children's Hospital Oakland
Oakland, California 94609
United States
Stanford University Clinical and Translational Research Unit
Palo Alto, California 94304
United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United States
Indiana University School of Medicine
Indianapolis, Indiana 46202
United States
University of Kentucky Medical Center
Lexington, Kentucky 40536
United States
Clinic for Special Children
Gordonville, Pennsylvania 17529
United States
University of Tennessee Health Science Center Le Bonheur Children's Hospital
Memphis, Tennessee 38103
United States