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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

ST-1891 is 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sention Therapeutics, LLC

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