A Study to Evaluate the Long-Term Safety and Efficacy of JNT-517 in Participants With Phenylketonuria

Study Identifier:

JNT517-501

ClinicalTrials.gov Identifier:

NCT06628128

EudraCT Identifier:

N/A

EU CT ID:

N/A

Study Contact Information:

844-687-8522 or [email protected]

Will Be Recruiting

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Study Details

Medical Condition

Phenylketonuria (PKU)

Study Drug

Drug: JNT-517 Tablet

Date

Jun 2025 - Nov 2027

Phase 1/2

Phase 2/3

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 12+ years

Requirements Information

Protocol Summary

The goal of this Phase 3, open-label extension study is to evaluate the long-term safety and efficacy of JNT-517 in participants with Phenylketonuria (PKU) after completion of either Study JNT517-101 or JNT517-201. In this long-term extension (LTE) study, all adults (aged ≥18 years) who complete Study JNT517-101 will be randomized 1:1 to receive JNT-517 at 75 mg twice daily (BID) or 150 mg BID, regardless of their previous dose. Adolescent participants who complete Study JNT517-201 will receive the same JNT-517 dose of the cohort they were initially assigned to, either 75 mg BID or 150 mg BID.

Study Locations

No locations found.