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

Phase 2

Completed

• Conditions: Hypothyroidism
• Interventions: Drug: ST-1891; Drug: Levothyroxine

• Registration Number: NCT05412979
• Lead Sponsor: Sention Therapeutics, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-29
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-09
• Primary Completion: 2023-10-04
• Study Completion: 2023-10-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ST-1891	ST-1891	-
Levothyroxine	Levothyroxine	-

Primary Outcome Measures

Name	Time	Method
Levothyroxine-to-ST-1891 dosing conversion factor	Week 52

Secondary Outcome Measures

Name	Time	Method
Time to TSH normalization	Week 52
Percent of patients with a thyroid-stimulating hormone (TSH) level within the standard reference range	Week 52

Trial Locations

Locations (1)

Sention Investigational Site; 🇺🇸 Renton, Washington, United States