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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 25 to 26v11
  2. Primary endpoint(s) modified Study sites: 24 to 25 · Eligibility criteria expanded, about 9 words · Secondary endpoints: 5 to 24 · 1 morev10 Show 4 more changesShow less
    • Study sites: 24 to 25
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 5 to 24
    • Study title shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria revisedv9 See this version in full on ClinicalTrials.gov ↗
  4. Primary completion pushed from Nov 15, 2027 to Mar 1, 2028 Trial sites expanded: 20 → 24 locations · Completion pushed from Dec 15, 2027 to Apr 1, 2028v8 Show 2 more changesShow less
    • Trial sites expanded: 20 → 24 locations
    • Completion pushed from Dec 15, 2027 to Apr 1, 2028
  5. Study sites: 15 to 20v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Nov 1, 2026 to Nov 15, 2027 Study sites: 8 to 15 · Completion date: Oct 1, 2027 to Dec 15, 2027v6 Show 2 more changesShow less
    • Study sites: 8 to 15
    • Completion date: Oct 1, 2027 to Dec 15, 2027
  2. Study sites: 2 to 8 Start date: Oct 24, 2025 to Oct 20, 2025v5 Show 1 more changeShow less
    • Start date: Oct 24, 2025 to Oct 20, 2025
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Primary completion date: Nov 2026 to Nov 1, 2026 · Completion date: Oct 2027 to Oct 1, 2027 · 2 morev4 Show 5 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Nov 2026 to Nov 1, 2026
    • Completion date: Oct 2027 to Oct 1, 2027
    • Start date changed from estimate of Aug 2025 to Oct 24, 2025
    • Eligibility criteria expanded, about 465 words

    See this version in full on ClinicalTrials.gov ↗

  4. Lead sponsor: Jnana Therapeutics to Otsuka Pharmaceutical Development & Commercialization, Inc. Collaborators shortened, about 6 wordsv3 Show 1 more changeShow less
    • Collaborators shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study title expanded, about 5 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06971731
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Phenylketonuria
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov