A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism
- Conditions
- Hypothyroidism
- Registration Number
- NCT05412979
- Lead Sponsor
- Sention Therapeutics, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 490
Inclusion Criteria:<br><br> - Diagnosed with primary hypothyroidism<br><br> - On continuous thyroid replacement therapy with levothyroxine for at least 12 months<br> immediately prior to Screening<br><br> - On a stable daily dose of levothyroxine for the 3 months prior to Screening<br><br> - Willing to give written informed consent for the Study<br><br>Exclusion Criteria:<br><br> - Any clinical condition or previous surgery that might affect the absorption,<br> distribution, biotransformation or excretion of ST-1891 or levothyroxine<br><br> - Female patients who are pregnant or are breastfeeding starting 30 days prior to<br> Screening<br><br> - Anticipated initiation or change in concomitant medications<br><br> - Concomitant use of prohibited medications<br><br> - Currently participating in another clinical study or have received active treatment<br> with an investigational drug within 30 days or 5 half-lives of the investigational<br> drug of Screening, whichever is longer
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Levothyroxine-to-ST-1891 dosing conversion factor
- Secondary Outcome Measures
Name Time Method Percent of patients with a thyroid-stimulating hormone (TSH) level within the standard reference range;Time to TSH normalization