Clinical trial NCT05412979: A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypothyroidism
Lead sponsor: Sention Therapeutics, LLC
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Levothyroxine-to-ST-1891 dosing conversion factor
timeFrame: Week 52
Secondary outcomes:
measure: Percent of patients with a thyroid-stimulating hormone (TSH) level within the standard reference range
timeFrame: Week 52
measure: Time to TSH normalization
timeFrame: Week 52
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: Sention Investigational Site
state: California
city: Newhall
country: United States
facility: Sention Investigational Site
state: California
city: Denver
country: United States
facility: Sention Investigational Site
state: Colorado
city: Fort Lauderdale
country: United States
facility: Sention Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Sention Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Sention Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Sention Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Sention Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: Sention Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Sention Investigational Site
state: Georgia
city: Evergreen Park
country: United States
facility: Sention Investigational Site
state: Illinois
city: Newburgh
country: United States
facility: Sention Investigational Site
state: Indiana
city: South Bend
country: United States
facility: Sention Investigational Site
state: Indiana
city: Ankeny
country: United States
facility: Sention Investigational Site
state: Iowa
city: Louisville
country: United States
facility: Sention Investigational Site
state: Kentucky
city: Dearborn
country: United States
facility: Sention Investigational Site
state: Michigan
city: Chesterfield
country: United States
facility: Sention Investigational Site
state: Missouri
city: Jefferson City
country: United States
facility: Sention Investigational Site
state: Missouri
city: Staten Island
country: United States
facility: Sention Investigational Site
state: New York
city: Cary
country: United States
facility: Sention Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: Sention Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Sention Investigational Site
state: North Carolina
city: Morehead City
country: United States
facility: Sention Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Sention Investigational Site
state: North Carolina
city: Rocky Mount
country: United States
facility: Sention Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Sention Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Sention Investigational Site
state: North Carolina
city: Mount Pleasant
country: United States
facility: Sention Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Sention Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Sention Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Sention Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Sention Investigational Site
state: Texas
city: Austin
country: United States
facility: Sention Investigational Site
state: Texas
city: Benbrook
country: United States
facility: Sention Investigational Site
state: Texas
city: Live Oak
country: United States
facility: Sention Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Sention Investigational Site
state: Texas
city: Webster
country: United States
facility: Sention Investigational Site
state: Texas
city: Virginia Beach
country: United States
facility: Sention Investigational Site
state: Virginia
city: Renton
country: United States
facility: Sention Investigational Site
state: Washington
Study officials:
References: