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NCT05412979 Clinical Trial

A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism

Hypothyroidism Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Crossover, Phase 2 Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05412979
Other study ID # ST-1891-201
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date April 29, 2022
Est. completion date December 2023

Study information
Verified date April 2023
Source Sention Therapeutics, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ST-1891-201 is a multicenter, randomized, double-blind, partial crossover, Phase 2 study evaluating the safety and efficacy of hormone replacement therapy with ST-1891 compared to levothyroxine in patients with primary hypothyroidism.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 490
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Diagnosed with primary hypothyroidism - On continuous thyroid replacement therapy with levothyroxine for at least 12 months immediately prior to Screening - On a stable daily dose of levothyroxine for the 3 months prior to Screening - Willing to give written informed consent for the Study Exclusion Criteria: - Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of ST-1891 or levothyroxine - Female patients who are pregnant or are breastfeeding starting 30 days prior to Screening - Anticipated initiation or change in concomitant medications - Concomitant use of prohibited medications - Currently participating in another clinical study or have received active treatment with an investigational drug within 30 days or 5 half-lives of the investigational drug of Screening, whichever is longer

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ST-1891
ST-1891
• Levothyroxine
Levothyroxine

Locations
Country Name City State
United States Sention Investigational Site Ankeny Iowa
United States Sention Investigational Site Atlanta Georgia
United States Sention Investigational Site Austin Texas
United States Sention Investigational Site Austin Texas
United States Sention Investigational Site Benbrook Texas
United States Sention Investigational Site Bristol Tennessee
United States Sention Investigational Site Cary North Carolina
United States Sention Investigational Site Chattanooga Tennessee
United States Sention Investigational Site Chesterfield Missouri
United States Sention Investigational Site Dearborn Michigan
United States Sention Investigational Site Denver Colorado
United States Sention Investigational Site Evergreen Park Illinois
United States Sention Investigational Site Fort Lauderdale Florida
United States Sention Investigational Site Greenbrae California
United States Sention Investigational Site Greenville North Carolina
United States Sention Investigational Site Hickory North Carolina
United States Sention Investigational Site Jacksonville Florida
United States Sention Investigational Site Jefferson City Missouri
United States Sention Investigational Site Lawrenceville Georgia
United States Sention Investigational Site Live Oak Texas
United States Sention Investigational Site Louisville Kentucky
United States Sention Investigational Site Memphis Tennessee
United States Sention Investigational Site Morehead City North Carolina
United States Sention Investigational Site Mount Pleasant South Carolina
United States Sention Investigational Site New Port Richey Florida
United States Sention Investigational Site Newburgh Indiana
United States Sention Investigational Site Newhall California
United States Sention Investigational Site Palm Harbor Florida
United States Sention Investigational Site Raleigh North Carolina
United States Sention Investigational Site Renton Washington
United States Sention Investigational Site Rocky Mount North Carolina
United States Sention Investigational Site Roswell Georgia
United States Sention Investigational Site Round Rock Texas
United States Sention Investigational Site Salisbury North Carolina
United States Sention Investigational Site South Bend Indiana
United States Sention Investigational Site Staten Island New York
United States Sention Investigational Site Virginia Beach Virginia
United States Sention Investigational Site Webster Texas
United States Sention Investigational Site Wilmington North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Sention Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Levothyroxine-to-ST-1891 dosing conversion factor Week 52
Secondary Percent of patients with a thyroid-stimulating hormone (TSH) level within the standard reference range Week 52
Secondary Time to TSH normalization Week 52
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