A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, and Efficacy of MZE782 in Adults With Phenylketonuria (PKU)

Maze Therapeutics

Summary

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

Eligibility

Age range: 18–75 years
Sex: All
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria: * Males and females 18 to 75 years old * Clinical 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 or within…

Interventions

Drug
MZE782
Tablet, Low Dose

Locations (6)

UCSF Benioff Children's Hospital Oakland
Oakland, California
Stanford University Clinical and Translational Research Unit
Palo Alto, California
Indiana University School of Medicine
Indianapolis, Indiana
University of Kentucky Medical Center
Lexington, Kentucky
Clinic for Special Children
Gordonville, Pennsylvania
University of Tennessee Health Science Center Le Bonheur Children's Hospital
Memphis, Tennessee