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First received: March 28, 2023

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

Study Status: ACTIVE_NOT_RECRUITING

Recruit Status: ACTIVE_NOT_RECRUITING

Condition: Hypothyroidism

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…

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