A Study of JNT-517 in Participants With Phenylketonuria (PKU)

ClinicalTrials.gov ID: NCT06971731

Public ClinicalTrials.gov record NCT06971731. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 5, 2026, 7:08 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Double-Blind, Randomized, Two-Period, Multicenter, Placebo-Controlled, Efficacy and Safety Study of JNT-517 for the Treatment of Participants With Phenylketonuria

Study identification

NCT ID: NCT06971731
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; Industry
Enrollment: 120 participants

Conditions and interventions

Conditions

Phenylketonuria

Interventions

JNT-517 Tablet Drug
Placebo Tablet: BID Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 19, 2025
Primary completion: Feb 29, 2028
Completion: Mar 31, 2028
Last update posted: May 3, 2026

2025 – 2028

United States locations

U.S. sites: 10
U.S. states: 8
U.S. cities: 10

Facility	City	State	ZIP	Site status
University of California Los Angeles (UCLA) School of Medicine	Los Angeles	California	90024	Recruiting
University of Florida (UF) Health Shands Hospital	Gainesville	Florida	32608	Recruiting
University of South Florida	Tampa	Florida	33606	Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	60611	Recruiting
Oregon Health and Science University	Portland	Oregon	97239	Recruiting
University of Pittsburgh Medical Center (UPMC) - Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	15201	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	37232	Recruiting
University of Texas Southwestern	Dallas	Texas	75390	Recruiting
University of Texas Health (UTHealth) Science Center at Houston	Houston	Texas	77030-1501	Recruiting
Utah Health - The University of Utah Hospital	Salt Lake City	Utah	84112	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06971731, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 3, 2026 · Synced May 5, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06971731 live on ClinicalTrials.gov.

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