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

Last updated: July 2, 2025
Sponsor: Xeris Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Thyroid Disease

Hormone Deficiencies

Hyponatremia

Treatment

levothyroxine sodium

Clinical Study ID

NCT05823012
XP-8121-120
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provide written informed consent.

  • Male or female between the ages of 18 and 65 years (inclusive) at Screening, withchronic hypothyroidism and on a stable dose of oral levothyroxine (Synthroid or anFDA-approved generic equivalent to Synthroid) or, if in the pharmacokineticsubstudy, Synthroid only for at least 3 months.

  • Thyroid stimulating hormone (TSH) within the normal range at Screening (centrallaboratory) and at least 3 months prior to Screening (documented by locallaboratory).

  • Free thyroxine within the normal range at Screening (central laboratory).

Exclusion

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 orSynthroid plus Armour Thyroid) and/or any other levothyroxine aside from those usedin the study.

Study Design

Total Participants: 46
Treatment Group(s): 1
Primary Treatment: levothyroxine sodium
Phase: 2
Study Start date:
May 15, 2023
Estimated Completion Date:
February 22, 2024

Study 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 participants during the Maintenance Period. The study will conclude with an End of Maintenance Visit or Early Termination (ET) Visit.

Connect with a study center

  • ProSciento, Inc.

    Chula Vista, California 91911
    United States

    Site Not Available

  • Catalina Research Institute, L.L.C.

    Montclair, California 91763
    United States

    Site Not Available

  • Jellinger and Lerman, MD LLC dba The Center for Diabetes and Endocrine Care

    Fort Lauderdale, Florida 33312
    United States

    Site Not Available

  • Panax Clinical Research, LLC

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • American Research Corporation

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Mt. Olympus Medical Research, LLC

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Site Not Available

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