Hypothyroidism
Conditions
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.
Interventions
DRUGST-1891
ST-1891
DRUGLevothyroxine
Levothyroxine
Sponsors
Sention Therapeutics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levothyroxine-to-ST-1891 dosing conversion factor | Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Percent of patients with a thyroid-stimulating hormone (TSH) level within the standard reference range | Week 52 |
| Time to TSH normalization | Week 52 |
Countries
United States
Outcome results
None listed