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New treatment option for Phenylketonuria (PKU)
Official title A Study of MZE782 in Adults With PKU
ClinicalTrials.gov ID: NCT07694440
What this study is testing
What is MZE782?
MZE782 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for phenylketonuria (pku).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety, tolerability, and efficacy of MZE782 in adults with Phenylketonuria (PKU).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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...
- Has recently received another investigational drug
- Is unable to swallow tablets or tolerate oral medication Other inclusion/exclusion criteria defined in protocol apply.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Gordonville, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; Gordonville, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.