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

Hypothyroidism Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05823012
• Other study ID #: XP-8121-120
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 21, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2024
• Source: Xeris Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Drug:
• levothyroxine sodium
Levothyroxine sodium 10 mg/mL

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Xeris Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose conversion factor	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	Day 29 of the Maintenance Period
Secondary	Proportion of subjects enrolled with normalized TSH	Proportion of subjects enrolled with normalized TSH at the end of Maintenance Period	Day 29 of the Maintenance Period
Secondary	Thyroid hormone concentrations	Blood thyroid hormone concentrations (total thyroxine, free thyroxine and TSH) following the first dose of XP-8121 in the Titration Period	Day 8