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Completed

NCT Number: NCT05412979

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

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.

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sention Investigational Site, Greenbrae, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ST-1891

Drug

ST-1891

Levothyroxine

Drug

Levothyroxine

Primary outcomes

  1. Levothyroxine-to-ST-1891 dosing conversion factor

    Time frame: Week 52

Secondary outcomes

  1. Percent of patients with a thyroid-stimulating hormone (TSH) level within the standard reference range

    Time frame: Week 52

  2. Time to TSH normalization

    Time frame: Week 52

Sponsors and collaborators

Lead sponsor

Sention Therapeutics, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2022
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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