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

August 22, 2024 updated by: Sention Therapeutics, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

490

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Greenbrae, California, United States, 94904
        • Sention Investigational Site
      • Newhall, California, United States, 91321
        • Sention Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80246
        • Sention Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33312
        • Sention Investigational Site
      • Jacksonville, Florida, United States, 32258
        • Sention Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Sention Investigational Site
      • Palm Harbor, Florida, United States, 34684
        • Sention Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Sention Investigational Site
      • Lawrenceville, Georgia, United States, 30046
        • Sention Investigational Site
      • Roswell, Georgia, United States, 30076
        • Sention Investigational Site
    • Illinois
      • Evergreen Park, Illinois, United States, 60805
        • Sention Investigational Site
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Sention Investigational Site
      • South Bend, Indiana, United States, 46617
        • Sention Investigational Site
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • Sention Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Sention Investigational Site
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Sention Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Sention Investigational Site
      • Jefferson City, Missouri, United States, 65109
        • Sention Investigational Site
    • New York
      • Staten Island, New York, United States, 10301
        • Sention Investigational Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Sention Investigational Site
      • Greenville, North Carolina, United States, 27834
        • Sention Investigational Site
      • Hickory, North Carolina, United States, 28601
        • Sention Investigational Site
      • Morehead City, North Carolina, United States, 28557
        • Sention Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Sention Investigational Site
      • Rocky Mount, North Carolina, United States, 27804
        • Sention Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • Sention Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Sention Investigational Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Sention Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Sention Investigational Site
      • Chattanooga, Tennessee, United States, 37411
        • Sention Investigational Site
      • Memphis, Tennessee, United States, 38133
        • Sention Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Sention Investigational Site
      • Austin, Texas, United States, 78749
        • Sention Investigational Site
      • Benbrook, Texas, United States, 76132
        • Sention Investigational Site
      • Live Oak, Texas, United States, 78233
        • Sention Investigational Site
      • Round Rock, Texas, United States, 78681
        • Sention Investigational Site
      • Webster, Texas, United States, 77598
        • Sention Investigational Site
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Sention Investigational Site
    • Washington
      • Renton, Washington, United States, 98057
        • Sention Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ST-1891
Drug: ST-1891
ST-1891
Active Comparator: Levothyroxine
Drug: Levothyroxine
Levothyroxine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Levothyroxine-to-ST-1891 dosing conversion factor
Time Frame: Week 52
Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent of patients with a thyroid-stimulating hormone (TSH) level within the standard reference range
Time Frame: Week 52
Week 52
Time to TSH normalization
Time Frame: Week 52
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sention Therapeutics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2022

Primary Completion (Actual)

October 4, 2023

Study Completion (Actual)

October 4, 2023

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 9, 2022

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST-1891-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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