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

NCT05412979
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Completed
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Participants
490
clinicaltrials.gov
Lead sponsor
Sention Therapeutics, LLC
clinicaltrials.gov
Start date
2022-04-29
clinicaltrials.gov
Number of sites
39
clinicaltrials.gov

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

Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2023-10-04
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First posted
2022-06-09
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Registry last updated
2024-08-26
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Primary completion date
2023-10-04
clinicaltrials.gov
Start date
2022-04-29
clinicaltrials.gov

Actual participants
490
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Participants
490
clinicaltrials.gov
Participant count basis
Actual
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Protocol amendments
3
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Number of sites
39
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Sention Therapeutics, LLC
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05412979
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05412979
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: Week 52

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)