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NCT04534842 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of SYNB1618 and SYNB1934 in Adult Patients With Phenylketonuria
A Phase 2 study, sponsored by Synlogic.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT04534842: Completed Phase 2 study, sponsored by Synlogic.
NCT04534842 is a Phase 2 study that has completed, run by Synlogic. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04534842, a Phase 2 study, has completed, sponsored by Synlogic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This Phase 2 study in patients with phenylketonuria (PKU) will be an open-label, dual-arm study of either a SYNB1618 or SYNB1934 dose-ramp regimen. All evaluations and assessments throughout this study may be conducted either at the clinical site or by a home healthcare professional at an alternative location (e.g., patient's home, hotel).
Primary Outcome
The primary efficacy outcome will be assessed by measuring change from baseline in plasma D5-Phe AUC over 24 hours after D5-Phe administration
Interventions
- DRUG SYNB1934
- DRUG SYNB1618
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2022-10-07 |
| Phase | Phase 2 |
What the finished NCT04534842 record still lists
NCT04534842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which SYNB1934 is the first listed.
NCT04534842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04534842 about?
NCT04534842 is a clinical study titled "Efficacy and Safety of SYNB1618 and SYNB1934 in Adult Patients With Phenylketonuria". This Phase 2 study in patients with phenylketonuria (PKU) will be an open-label, dual-arm study of either a SYNB1618 or SYNB1934 dose-ramp regimen. All evaluations and assessments throughout this study may be conducted either at the clinical site or by a home healthcare professional at an alternativ...
What is the current status of trial NCT04534842?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2020-08-25. Estimated completion is 2022-10-07.
What interventions are being tested in trial NCT04534842?
The interventions under investigation include: SYNB1934 (DRUG), SYNB1618 (DRUG).
Who is sponsoring clinical trial NCT04534842?
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 NCT04534842's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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