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)
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the safety, tolerability, and efficacy of MZE782 in adults with Phenylketonuria (PKU).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
California
UCSF Benioff Children's Hospital Oakland
RECRUITING
Oakland
Stanford University Clinical and Translational Research Unit
RECRUITING
Palo Alto
Indiana
Indiana University School of Medicine
RECRUITING
Indianapolis
Kentucky
University of Kentucky Medical Center
RECRUITING
Lexington
Pennsylvania
Clinic for Special Children
RECRUITING
Gordonville
Tennessee
University of Tennessee Health Science Center Le Bonheur Children's Hospital
RECRUITING
Memphis
Contact Information
Primary
Maze Therapeutics
medicalinfo@mazetx.com
650-850-5075
Time Frame
Start Date: 2026-06-23
Estimated Completion Date: 2028-02
Participants
Target number of participants: 38
Treatments
Experimental: MZE782 Low Dose (Cohort 1A)
Placebo_comparator: Placebo (Cohort 1A)
Experimental: MZE782 High Dose (Cohort 1B)
Placebo_comparator: Placebo (Cohort 1B)
Experimental: MZE782 High Dose (Cohort 2)
Placebo_comparator: Placebo (Cohort 2)
Related Therapeutic Areas
Sponsors
Leads: Maze Therapeutics