Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

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 (2 to 8 weeks), and Maintenance Period (4 weeks). A pharmacokinetic substudy will be conducted for a subset of patients during the Maintenance Period. The study will conclude with an End of Maintenance Visit or Early Termination (ET) Visit. ;

Study Design

Related Conditions & MeSH terms

Hypothyroidism

Clinical Trial Details

NCT number	NCT05823012
Study type	Interventional
Source	Xeris Pharmaceuticals
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	April 21, 2023
Completion date	May 31, 2024

View Details

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