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NCT05823012 · ClinicalTrials.gov registry record · Phase 2
Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism
A Phase 2 study, sponsored by Xeris Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT05823012: Completed Phase 2 study, sponsored by Xeris Pharmaceuticals.
NCT05823012 is a Phase 2 study that has completed, run by Xeris Pharmaceuticals. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05823012, a Phase 2 study, has completed, sponsored by Xeris Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
This is a non-randomized, open-label, single arm, self-controlled study of XP-8121 (levothyroxine sodium) to determine a target dose conversion factor from stably dosed oral levothyroxine to XP-8121 (levothyroxine sodium) in patients with hypothyroidism and to assess the safety and tolerability of XP-8121(levothyroxine sodium) after once weekly subcutaneous injections. This study includes the following periods: Screening, Titration Period, and Maintenance Period. The study will conclude with an End of Maintenance Visit or Early Termination (ET) Visit.
Primary Outcome
Geometric mean ratio of the weekly dose of XP-8121 to the daily dose of oral levothyroxine (aka dose conversion factor), where the XP-8121 dose corresponds to the administration immediately preceding collection of blood TSH used to determine normalization at the end of Maintenance Period. The dose conversion factor was assessed by comparing the natural log-transformed final XP-8121 dose in μg that maintained normalized TSH throughout the Maintenance Period to the natural log-transformed daily or
Interventions
- DRUG levothyroxine sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2023-05-15 |
| Est. Completion | 2024-02-22 |
| Phase | Phase 2 |
What the finished NCT05823012 record still lists
NCT05823012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which levothyroxine sodium is the first listed.
NCT05823012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05823012 about?
NCT05823012 is a clinical study titled "Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism". This is a non-randomized, open-label, single arm, self-controlled study of XP-8121 (levothyroxine sodium) to determine a target dose conversion factor from stably dosed oral levothyroxine to XP-8121 (levothyroxine sodium) in patients with hypothyroidism and to assess the safety and tolerability of X...
What is the current status of trial NCT05823012?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2023-05-15. Estimated completion is 2024-02-22.
What interventions are being tested in trial NCT05823012?
The interventions under investigation include: levothyroxine sodium (DRUG).
Who is sponsoring clinical trial NCT05823012?
This trial is sponsored by Xeris Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05823012's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 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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