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

Completed · Phase 2

Conditions studied: Hypothyroidism

In brief

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.

Key facts

Study ID

NCT05823012

Run by

Xeris Pharmaceuticals

People needed

46

Starts

2023-05-15

Expected to finish

2024-02-22

Last updated by the study team

2025-07-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• ProSciento, Inc. — Chula Vista, California, United States
• Catalina Research Institute, L.L.C. — Montclair, California, United States
• Panax Clinical Research, LLC — Miami Lakes, Florida, United States
• American Research Corporation — San Antonio, Texas, United States
• Mt. Olympus Medical Research, LLC — Sugar Land, Texas, United States
• Rainier Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

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