Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism
- Registration Number
- NCT05823012
- Lead Sponsor
- Xeris Pharmaceuticals
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description XP-8121 levothyroxine sodium XP-8121 100 to 1500 μg subcutaneous injection
- Primary Outcome Measures
Name Time Method Dose conversion factor Day 29 of the Maintenance Period 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
- Secondary Outcome Measures
Name Time Method Proportion of subjects enrolled with normalized TSH Day 29 of the Maintenance Period Proportion of subjects enrolled with normalized TSH at the end of Maintenance Period
Thyroid hormone concentrations Day 8 Blood thyroid hormone concentrations (total thyroxine, free thyroxine and TSH) following the first dose of XP-8121 in the Titration Period
Trial Locations
- Locations (6)
Panax Clinical Research, LLC
🇺🇸Miami Lakes, Florida, United States
American Research Corporation
🇺🇸San Antonio, Texas, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
ProSciento, Inc.
🇺🇸Chula Vista, California, United States
Catalina Research Institute, L.L.C.
🇺🇸Montclair, California, United States
Mt. Olympus Medical Research, LLC
🇺🇸Sugar Land, Texas, United States