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

Study Status: ACTIVE_NOT_RECRUITING
Recruit Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL

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

Brief 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.

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 (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.
Sponsor: Xeris Pharmaceuticals

Current 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

Original 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

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Xeris Pharmaceuticals

Dates:
Date Received: March 28, 2023
Date Started: April 21, 2023
Date Completion: April 21, 2023
Last Updated: January 02, 2024
Last Verified: January 01, 2024