XP-8121-120

About this trial

Last updated 2 years ago

Study ID

XP-8121-120

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18 to 65 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended a year ago

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.

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.