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A Study to Evaluate the Safety and Efficacy of JNT-517 in Participants With Phenylketonuria (PKU)
NCT06971731 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this Phase 3, randomized study is to assess the safety, efficacy, tolerability, and pharmacokinetics (PK) of oral JNT-517 in adults (18 years of age or older) with PKU. Participants will receive either JNT-517 or placebo and will be blinded to their treatment assignment. Participants will have a 2 in 3 (or approximately 67%) chance of receiving JNT-517 during the first part of the study which will last approximately six weeks. During the second part of the study every participant who continues in the study will receive one of two doses of JNT-517 for an additional 46 weeks. The study requires a screening period of up to 35 days to ensure dietary stabilization and amino acid levels required to meet study eligibility. In total, participation in the study could last for up to 400 days. Participants will: Take 75 mg JNT-517 or 150 mg JNT-517, or a placebo BID (2x per day) for approximately 365 days; Visit the clinic or have a mobile health nurse visit your home for checkups and tests; Collect urine sample at home and bring to clinic on specified days; Keep a food diary 3 days before each study visit
Conditions Studied
Interventions
- DRUG JNT-517 Tablet
- DRUG Placebo Tablet: BID
Study Locations (20)
Other
- Royal Adelaide Hospital — Adelaide
- Royal Melbourne Hospital — Parkville
- Mater Health - Mater Hospital Brisbane — South Brisbane
- Centre Hospitalier Régional Universitaire (CHRU) de Tours - Hôpital Bretonneau — Tours
- Nihon University Hospital — Chiyoda-ku
- Osaka Metropolitan University Hospital — Osaka
- Universitair Medisch Centra (AMC)- Amsterdam — Amsterdam
- Beatrix Children's Hospital — Groningen
- Pomorski Uniwersytet Medyczny w Szczecinie — Szczecin
- Hospital Universitario Ramón y Cajal — Madrid
- Hospital Clinico Universitario de Santiago de Compostela — Santiago de Compostela
Texas
- University of Texas Southwestern — Dallas
- University of Texas Health (UTHealth) Science Center at Houston — Houston
California
- University of California Los Angeles (UCLA) School of Medicine — Los Angeles
Florida
- University of Florida (UF) Health Shands Hospital — Gainesville
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Oregon
- Oregon Health and Science University — Portland
Pennsylvania
- University of Pittsburgh Medical Center (UPMC) - Children's Hospital of Pittsburgh — Pittsburgh
Tennessee
- Vanderbilt University Medical Center — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-10-20 |
| Est. Completion | 2027-12-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06971731
The ClinicalTrials.gov registry entry for NCT06971731 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 79 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Phenylketonuria appearing as the primary indexed condition, and to 2 interventions — of which JNT-517 Tablet is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06971731 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06971731 about?
NCT06971731 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of JNT-517 in Participants With Phenylketonuria (PKU)". The goal of this Phase 3, randomized study is to assess the safety, efficacy, tolerability, and pharmacokinetics (PK) of oral JNT-517 in adults (18 years of age or older) with PKU. Participants will receive either JNT-517 or placebo and will be blinded to their treatment assignment. Participants wil...
What is the current status of trial NCT06971731?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2025-10-20. Estimated completion is 2027-12-15.
What conditions does trial NCT06971731 study?
This clinical trial studies the following conditions: Phenylketonuria. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06971731?
The interventions under investigation include: JNT-517 Tablet (DRUG), Placebo Tablet: BID (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06971731?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 79 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06971731 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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