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

Sponsor
Xeris Pharmaceuticals (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05823012
Collaborator
(none)
44
Enrollment
1
Arm
8
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: levothyroxine sodium
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Non-Randomized, Open-Label, Single Arm, Self-controlled Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: XP-8121

XP-8121 100 to 1500 μg subcutaneous injection

Drug: levothyroxine sodium
Levothyroxine sodium 10 mg/mL
Other Names:
  • XP-8121

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Xeris Pharmaceuticals

    Investigators

    • Study Director: Valentina Conoscenti, MD, Xeris Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xeris Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05823012
    Other Study ID Numbers:
    • XP-8121-120
    First Posted:
    Apr 21, 2023
    Last Update Posted:
    Apr 21, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypothyroidism

    Study Results

    No Results Posted as of Apr 21, 2023