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NCT06971731 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of JNT-517 in Participants With Phenylketonuria (PKU)
A Phase 3 study of Phenylketonuria, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT06971731: Recruiting Phase 3 study of Phenylketonuria, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT06971731 is a Phase 3 study of Phenylketonuria that is actively recruiting participants, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 120 participants, above the 89-participant average among 12 other Phenylketonuria trials with a reported enrollment target (35% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06971731, a Phase 3 study of Phenylketonuria, is actively recruiting participants, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
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 |
What NCT06971731 shows while recruiting
NCT06971731 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 89-participant average among 12 other Phenylketonuria trials with a reported enrollment target (35% higher).
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.
NCT06971731 names 20 study sites across 9 states, led by Other, Texas, California.
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.
What interventions are being tested in trial NCT06971731?
The interventions under investigation include: JNT-517 Tablet (DRUG), Placebo Tablet: BID (DRUG).
Who is sponsoring clinical trial NCT06971731?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06971731's enrollment target sits among peer trials
120 5th of 12 higher than 8 of 12 other Phenylketonuria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phenylketonuria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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