CompletedPhase 2

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

United States46 participantsStarted 2023-05-15

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * Thyroid stimulating hormone (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.

What they're measuring

Dose Conversion Factor

Timeframe: Day 29 of the Maintenance Period

Tolerability Assessment: Modified Draize Scale - Erythema

Timeframe: Week 1 Dosing in Titration Period through Day 22 Dosing in Maintenance Period

Tolerability Assessment: Modified Draize Scale - Edema

Timeframe: Week 1 Dosing in Titration Period through Day 22 Dosing in Maintenance Period

Tolerability Assessments: Injection Site Discomfort Evaluation

Timeframe: Week 1 dosing in the Titration Period through Day 22 dosing in the Maintenance Period

Trial details

NCT IDNCT05823012

SponsorXeris Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-22

Results submitted2025-06-04

View on ClinicalTrials.gov More Hypothyroidism trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Dose Conversion Factor

Timeframe: Day 29 of the Maintenance Period

Tolerability Assessment: Modified Draize Scale - Erythema

Timeframe: Week 1 Dosing in Titration Period through Day 22 Dosing in Maintenance Period

Tolerability Assessment: Modified Draize Scale - Edema

Timeframe: Week 1 Dosing in Titration Period through Day 22 Dosing in Maintenance Period

Tolerability Assessments: Injection Site Discomfort Evaluation

Timeframe: Week 1 dosing in the Titration Period through Day 22 dosing in the Maintenance Period