HypothyroidismPhase 2NCT05412979
A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism
A Phase 2 study testing ST-1891 and Levothyroxine in people with Hypothyroidism, run by Sention Therapeutics, LLC at 39 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- ST-1891 and Levothyroxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 39 sitesUnited States
- Study dates
- 29 Apr 2022to 4 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Sention Investigational Site
Ankeny, Iowa, 50023
Sention Investigational Site
Atlanta, Georgia, 30318
Sention Investigational Site
Austin, Texas, 78731
Sention Investigational Site
Austin, Texas, 78749
Sention Investigational Site
Benbrook, Texas, 76132
Sention Investigational Site
Bristol, Tennessee, 37620
Sention Investigational Site
Cary, North Carolina, 27518
Sention Investigational Site
Chattanooga, Tennessee, 37411
Sention Investigational Site
Chesterfield, Missouri, 63017
Sention Investigational Site
Dearborn, Michigan, 48126
Sention Investigational Site
Denver, Colorado, 80246
Sention Investigational Site
Evergreen Park, Illinois, 60805
Sention Investigational Site
Fort Lauderdale, Florida, 33312
Sention Investigational Site
Greenbrae, California, 94904
Sention Investigational Site
Greenville, North Carolina, 27834
Sention Investigational Site
Hickory, North Carolina, 28601
Sention Investigational Site
Jacksonville, Florida, 32258
Sention Investigational Site
Jefferson City, Missouri, 65109
Sention Investigational Site
Lawrenceville, Georgia, 30046
Sention Investigational Site
Live Oak, Texas, 78233
Sention Investigational Site
Louisville, Kentucky, 40213
Sention Investigational Site
Memphis, Tennessee, 38133
Sention Investigational Site
Morehead City, North Carolina, 28557
Sention Investigational Site
Mt. Pleasant, South Carolina, 29464
Sention Investigational Site
New Port Richey, Florida, 34652
Sention Investigational Site
Newburgh, Indiana, 47630
Sention Investigational Site
Newhall, California, 91321
Sention Investigational Site
Palm Harbor, Florida, 34684
Sention Investigational Site
Raleigh, North Carolina, 27609
Sention Investigational Site
Renton, Washington, 98057
Sention Investigational Site
Rocky Mount, North Carolina, 27804
Sention Investigational Site
Roswell, Georgia, 30076
Sention Investigational Site
Round Rock, Texas, 78681
Sention Investigational Site
Salisbury, North Carolina, 28144
Sention Investigational Site
South Bend, Indiana, 46617
Sention Investigational Site
Staten Island, New York, 10301
Sention Investigational Site
Virginia Beach, Virginia, 23462
Sention Investigational Site
Webster, Texas, 77598
Sention Investigational Site
Wilmington, North Carolina, 28401
About this study
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
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.
- Conditions
- Hypothyroidism
- Being tested
- ST-1891, Levothyroxine
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST-1891Drug
ST-1891
LevothyroxineDrug
Levothyroxine
| Study group | Role | What they receive |
|---|---|---|
| ST-1891 | Experimental | Not described Receives: Drug: ST-1891 |
| Levothyroxine | Active comparator | Not described Receives: Drug: Levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levothyroxine-to-ST-1891 dosing conversion factor
Measured: Week 52
Secondary outcomes (2)
Percent of patients with a thyroid-stimulating hormone (TSH) level within the standard reference range
Measured: Week 52
Time to TSH normalization
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start29 Apr 2022
- Primary completion4 Oct 2023
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sention Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412979
- Sponsor's protocol ID
- ST-1891-201
- Status last verified
- Aug 2024
- First submitted
- 2 Jun 2022
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 ID
- NCT05412979
- Acronym / sponsor ID
- ST-1891-201
- Conditions
- Hypothyroidism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Sention Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 4 Oct 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ST-1891 | Experimental | Drug: ST-1891 |
| Levothyroxine | Active comparator | Drug: Levothyroxine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST-1891ST-1891 | Drug | ST-1891 |
| LevothyroxineLevothyroxine | Drug | Levothyroxine |
Primary outcome
Levothyroxine-to-ST-1891 dosing conversion factor
Time frame: Week 52
2 secondary outcomes
Percent of patients with a thyroid-stimulating hormone (TSH) level within the standard reference range
Time frame: Week 52
Time to TSH normalization
Time frame: Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ST-1891 and Levothyroxine in people with Hypothyroidism, run by Sention Therapeutics, LLC at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levothyroxine-to-ST-1891 dosing conversion factor (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.