CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
levothyroxine sodiumdrug
Likely dose
levothyroxine sodium 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05823012
NCT05823012Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Non-Randomized, Open-Label, Single Arm, Self-controlled Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism

Xeris Pharmaceuticals·interventional·Posted Apr 21, 2023·Updated Jul 3, 2025

In Brief

A Phase 2 clinical trial evaluating levothyroxine sodium for Hypothyroidism. Completed, enrolled 46 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypothyroidism
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202420252026
First PostedApr 21, 2023
Enrollment StartMay 15, 2023
Primary CompletionFeb 22, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.2 years ago

Interventions

levothyroxine sodiumdrug

Levothyroxine sodium 10 mg/mL