A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism
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
1 other identifier
interventional
490
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2022
Shorter than P25 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 29, 2022
CompletedFirst Submitted
Initial submission to the registry
June 2, 2022
CompletedFirst Posted
Study publicly available on registry
June 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2023
CompletedAugust 26, 2024
August 1, 2024
1.4 years
June 2, 2022
August 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Levothyroxine-to-ST-1891 dosing conversion factor
Week 52
Secondary Outcomes (2)
Percent of patients with a thyroid-stimulating hormone (TSH) level within the standard reference range
Week 52
Time to TSH normalization
Week 52
Study Arms (2)
ST-1891
EXPERIMENTALLevothyroxine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Sention Investigational Site
Greenbrae, California, 94904, United States
Sention Investigational Site
Newhall, California, 91321, United States
Sention Investigational Site
Denver, Colorado, 80246, United States
Sention Investigational Site
Fort Lauderdale, Florida, 33312, United States
Sention Investigational Site
Jacksonville, Florida, 32258, United States
Sention Investigational Site
New Port Richey, Florida, 34652, United States
Sention Investigational Site
Palm Harbor, Florida, 34684, United States
Sention Investigational Site
Atlanta, Georgia, 30318, United States
Sention Investigational Site
Lawrenceville, Georgia, 30046, United States
Sention Investigational Site
Roswell, Georgia, 30076, United States
Sention Investigational Site
Evergreen Park, Illinois, 60805, United States
Sention Investigational Site
Newburgh, Indiana, 47630, United States
Sention Investigational Site
South Bend, Indiana, 46617, United States
Sention Investigational Site
Ankeny, Iowa, 50023, United States
Sention Investigational Site
Louisville, Kentucky, 40213, United States
Sention Investigational Site
Dearborn, Michigan, 48126, United States
Sention Investigational Site
Chesterfield, Missouri, 63017, United States
Sention Investigational Site
Jefferson City, Missouri, 65109, United States
Sention Investigational Site
Staten Island, New York, 10301, United States
Sention Investigational Site
Cary, North Carolina, 27518, United States
Sention Investigational Site
Greenville, North Carolina, 27834, United States
Sention Investigational Site
Hickory, North Carolina, 28601, United States
Sention Investigational Site
Morehead City, North Carolina, 28557, United States
Sention Investigational Site
Raleigh, North Carolina, 27609, United States
Sention Investigational Site
Rocky Mount, North Carolina, 27804, United States
Sention Investigational Site
Salisbury, North Carolina, 28144, United States
Sention Investigational Site
Wilmington, North Carolina, 28401, United States
Sention Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
Sention Investigational Site
Bristol, Tennessee, 37620, United States
Sention Investigational Site
Chattanooga, Tennessee, 37411, United States
Sention Investigational Site
Memphis, Tennessee, 38133, United States
Sention Investigational Site
Austin, Texas, 78731, United States
Sention Investigational Site
Austin, Texas, 78749, United States
Sention Investigational Site
Benbrook, Texas, 76132, United States
Sention Investigational Site
Live Oak, Texas, 78233, United States
Sention Investigational Site
Round Rock, Texas, 78681, United States
Sention Investigational Site
Webster, Texas, 77598, United States
Sention Investigational Site
Virginia Beach, Virginia, 23462, United States
Sention Investigational Site
Renton, Washington, 98057, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2022
First Posted
June 9, 2022
Study Start
April 29, 2022
Primary Completion
October 4, 2023
Study Completion
October 4, 2023
Last Updated
August 26, 2024
Record last verified: 2024-08