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

Xeris Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Hypothyroidism

Treatments

Drug: levothyroxine sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT05823012

XP-8121-120

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provide written informed consent.
Male or female between the ages of 18 and 65 years (inclusive) at Screening, with chronic hypothyroidism and on a stable dose of oral levothyroxine (Synthroid or an FDA-approved generic equivalent to Synthroid) or, if in the pharmacokinetic substudy, Synthroid only for at least 3 months.
TSH within the normal range at Screening (central laboratory) and at least 3 months prior to Screening (documented by local laboratory).
Free thyroxine within the normal range at Screening (central laboratory).

Exclusion criteria

History of hypersensitivity to levothyroxine (any formulation).
Current dose of oral levothyroxine, based on body weight >2 μg/kg/day.
Current levothyroxine total daily dose either <50 μg or >375 μg.
Current use of combined thyroid treatment (i.e., Synthroid plus liothyronine or Synthroid plus Armour Thyroid) and/or any other levothyroxine aside from those used in the study.