> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-evaluating-the-safety-and-efficacy-of-hormone-02140526-7e9e-4124-b8ca-bf8c785c0fab > Record changed: 2026-10-13 # A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism NCT05412979 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) Participants 490 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) Lead sponsor Sention Therapeutics, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) Start date 2022-04-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) Number of sites 39 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Short title** A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) ## Dates **Completion date** 2023-10-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **First posted** 2022-06-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Registry last updated** 2024-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Primary completion date** 2023-10-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Start date** 2022-04-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) ## Size and sites **Actual participants** 490 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Participants** 490 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Number of sites** 39 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Lead sponsor** Sention Therapeutics, LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) ## Identifiers **Registry ID** NCT05412979 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **ClinicalTrials.gov ID** NCT05412979 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) ## Outcomes ### Primary outcomes 1. Levothyroxine-to-ST-1891 dosing conversion factor Timeframe: Week 52 ### Secondary outcomes 1. Percent of patients with a thyroid-stimulating hormone (TSH) level within the standard reference range Timeframe: Week 52 2. Time to TSH normalization Timeframe: Week 52 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) ## Sites - Sention Investigational SiteGreenbrae, United States - Sention Investigational SiteNewhall, United States - Sention Investigational SiteDenver, United States - Sention Investigational SiteFort Lauderdale, United States - Sention Investigational SiteJacksonville, United States - Sention Investigational SiteNew Port Richey, United States - Sention Investigational SitePalm Harbor, United States - Sention Investigational SiteAtlanta, United States - Sention Investigational SiteLawrenceville, United States - Sention Investigational SiteRoswell, United States - Sention Investigational SiteEvergreen Park, United States - Sention Investigational SiteNewburgh, United States - Sention Investigational SiteSouth Bend, United States - Sention Investigational SiteAnkeny, United States - Sention Investigational SiteLouisville, United States - Sention Investigational SiteDearborn, United States - Sention Investigational SiteChesterfield, United States - Sention Investigational SiteJefferson City, United States - Sention Investigational SiteStaten Island, United States - Sention Investigational SiteCary, United States - Sention Investigational SiteGreenville, United States - Sention Investigational SiteHickory, United States - Sention Investigational SiteMorehead City, United States - Sention Investigational SiteRaleigh, United States - Sention Investigational SiteRocky Mount, United States And 14 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05412979) ## Related records ### Drugs (1) - [Levothyroxine sodium](https://trialight.com/data/asset/levothyroxine-sodium-748a279d-1239-41f1-b758-863bd96e359b.md) ### Lead sponsors (1) - [Sention Therapeutics, LLC](https://trialight.com/data/company/sention-therapeutics-llc-f6c31814-83e0-4d88-9010-74143ba4ced0.md) ### Conditions (1) - [Hypothyroidism](https://trialight.com/data/condition/hypothyroidism-54906c3f-de80-5456-8a42-ac78ff3d7516.md) Primary condition ### Targets (2) - [THRA](https://trialight.com/data/target/thra-794e5b29-0985-5208-bfb5-40a8ff0430b7.md) - [THRB](https://trialight.com/data/target/thrb-42c6ac46-f168-5889-b57f-2262a46613d4.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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