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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 * 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 90 days after the last dose * 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

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Conditions

Phenylketonuria (PKU)

Locations

Indiana University School of Medicine

Indianapolis, Indiana 46202

United States

Clinic for Special Children

Gordonville, Pennsylvania 17529

United States