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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 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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 89-participant average among 12 other Phenylketonuria trials with a reported enrollment target (35% higher). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.