Back to resultsStudy of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism
Primary Purpose
Hypothyroidism
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
levothyroxine sodium
Sponsored by
About this trial
This is an interventional treatment trial for Hypothyroidism
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.
Sites / Locations
- ProSciento, Inc.Recruiting
- Catalina Research Institute, L.L.C.Recruiting
- Jellinger and Lerman, MD LLC dba The Center for Diabetes and Endocrine Care
- Panax Clinical Research, LLCRecruiting
- American Research CorporationRecruiting
- Mt. Olympus Medical Research, LLCRecruiting
- Rainier Clinical Research CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
XP-8121
Arm Description
XP-8121 100 to 1500 μg subcutaneous injection
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Proportion of subjects enrolled with normalized TSH
Proportion of subjects enrolled with normalized TSH at the end of Maintenance Period
Thyroid hormone concentrations
Blood thyroid hormone concentrations (total thyroxine, free thyroxine and TSH) following the first dose of XP-8121 in the Titration Period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05823012
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xeris Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
XP-8121
Arm Type
Experimental
Arm Description
XP-8121 100 to 1500 μg subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
levothyroxine sodium
Other Intervention Name(s)
XP-8121
Intervention Description
Levothyroxine sodium 10 mg/mL
Primary Outcome Measure Information:
Title
Dose conversion factor
Description
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
Time Frame
Day 29 of the Maintenance Period
Secondary Outcome Measure Information:
Title
Proportion of subjects enrolled with normalized TSH
Description
Proportion of subjects enrolled with normalized TSH at the end of Maintenance Period
Time Frame
Day 29 of the Maintenance Period
Title
Thyroid hormone concentrations
Description
Blood thyroid hormone concentrations (total thyroxine, free thyroxine and TSH) following the first dose of XP-8121 in the Titration Period
Time Frame
Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina Conoscenti, MD
Phone
1-877-XERIS-37
Email
Clinicaltrials@xerispharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentina Conoscenti, MD
Organizational Affiliation
Xeris Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
ProSciento, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recruiting Contact
Phone
866-308-7427
Email
hello@myproscientostudy.com
Facility Name
Catalina Research Institute, L.L.C.
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recruiting Contact
Phone
909-590-6307
Email
info@catalinari.com
Facility Name
Jellinger and Lerman, MD LLC dba The Center for Diabetes and Endocrine Care
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Individual Site Status
Withdrawn
Facility Name
Panax Clinical Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Revoredo
Phone
305-698-4500
Email
nrevoredo@panaxcr.com
Facility Name
American Research Corporation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recruiting Contact
Phone
210-253-3426
Facility Name
Mt. Olympus Medical Research, LLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recruiting Contact
Phone
346-397-4457
Email
Thakkar@mtolympusresearch.com
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recruiting Contact
Phone
425-251-1720
Email
fbroyles@rainier-research.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism
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