Clinical trial NCT05823012: Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypothyroidism
Lead sponsor: Xeris Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dose conversion factor
timeFrame: Day 29 of the Maintenance Period
Secondary outcomes:
measure: Proportion of subjects enrolled with normalized TSH
timeFrame: Day 29 of the Maintenance Period
measure: Thyroid hormone concentrations
timeFrame: Day 8
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: ProSciento, Inc.
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, L.L.C.
state: California
city: Miami Lakes
country: United States
facility: Panax Clinical Research, LLC
state: Florida
city: San Antonio
country: United States
facility: American Research Corporation
state: Texas
city: Sugar Land
country: United States
facility: Mt. Olympus Medical Research, LLC
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Xeris Pharmaceuticals, Inc.
name: Valentina Conoscenti, MD
role: STUDY_DIRECTOR
References: