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NCT05764239 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)
A Phase 3 study, sponsored by Synlogic.
- Terminated
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
NCT05764239: Clinical Trial Phase 3 study, sponsored by Synlogic.
NCT05764239 is a Phase 3 study that was terminated before completion, run by Synlogic. The registered enrollment target is 35 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05764239, a Phase 3 study, was terminated before completion, sponsored by Synlogic.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
Study Summary
SYNB1934-CP-003 was designed as a 3-part, adaptive study consisting of a dose-escalating, open-label period (DEP; Part 1) of up to 15 weeks, followed by a 4-week, double-blind, placebo-controlled, randomized withdrawal period (RWP; Part 2), and an open-label extension (OLE; Part 3) of up to 36 months
Primary Outcome
Baseline for blood Phe level in the DEP was defined as the mean of the duplicate blood Phe level measurements obtained immediately prior to administration of the first dose in the DEP. If only 1 blood Phe level measurement was available, then that measure was used as baseline. The last measurement was the participant's last Week 3 blood Phe level at the iTD of SYNB1934v1.
Interventions
- DRUG Placebo
- DRUG SYNB1934v1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2023-07-05 |
| Est. Completion | 2024-03-15 |
| Phase | Phase 3 |
Why NCT05764239 stopped before completion
NCT05764239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05764239 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05764239 about?
NCT05764239 is a clinical study titled "Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)". SYNB1934-CP-003 was designed as a 3-part, adaptive study consisting of a dose-escalating, open-label period (DEP; Part 1) of up to 15 weeks, followed by a 4-week, double-blind, placebo-controlled, randomized withdrawal period (RWP; Part 2), and an open-label extension (OLE; Part 3) of up to 36 month...
What is the current status of trial NCT05764239?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2023-07-05. Estimated completion is 2024-03-15.
What interventions are being tested in trial NCT05764239?
The interventions under investigation include: Placebo (DRUG), SYNB1934v1 (DRUG).
Who is sponsoring clinical trial NCT05764239?
This trial is sponsored by Synlogic, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05764239's enrollment target sits among peer trials
35 1903rd of 2000 higher than 96 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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