A Study of MZE782 in Adults With PKU

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)

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

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.