A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism
Sponsor
Sention Therapeutics, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05412979
Collaborator
(none)
300
39
2
19.1
7.7
0.4
Study Details
Study Description
Brief Summary
ST-1891-201 is 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Apr 29, 2022
Anticipated Primary Completion Date
:
Jun 1, 2023
Anticipated Study Completion Date
:
Dec 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ST-1891
|
Drug: ST-1891
ST-1891
|
| Active Comparator: Levothyroxine
|
Drug: Levothyroxine
Levothyroxine
|
Outcome Measures
Primary Outcome Measures
- Percent of patients with thyroid-stimulating hormone levels within the standard reference range [Week 26]
Secondary Outcome Measures
- The ratio of the levothyroxine daily dose at Screening to the ST-1891 daily dose at Week 26 for patients with thyroid-stimulating hormone levels within the standard reference range per central laboratory testing at Week 26 [Week 26]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sention Investigational Site | Greenbrae | California | United States | 94904 |
| 2 | Sention Investigational Site | Newhall | California | United States | 91321 |
| 3 | Sention Investigational Site | Denver | Colorado | United States | 80246 |
| 4 | Sention Investigational Site | Fort Lauderdale | Florida | United States | 33312 |
| 5 | Sention Investigational Site | Jacksonville | Florida | United States | 32258 |
| 6 | Sention Investigational Site | New Port Richey | Florida | United States | 34652 |
| 7 | Sention Investigational Site | Palm Harbor | Florida | United States | 34684 |
| 8 | Sention Investigational Site | Atlanta | Georgia | United States | 30318 |
| 9 | Sention Investigational Site | Lawrenceville | Georgia | United States | 30046 |
| 10 | Sention Investigational Site | Roswell | Georgia | United States | 30076 |
| 11 | Sention Investigational Site | Evergreen Park | Illinois | United States | 60805 |
| 12 | Sention Investigational Site | Newburgh | Indiana | United States | 47630 |
| 13 | Sention Investigational Site | South Bend | Indiana | United States | 46617 |
| 14 | Sention Investigational Site | Ankeny | Iowa | United States | 50023 |
| 15 | Sention Investigational Site | Louisville | Kentucky | United States | 40213 |
| 16 | Sention Investigational Site | Dearborn | Michigan | United States | 48126 |
| 17 | Sention Investigational Site | Chesterfield | Missouri | United States | 63017 |
| 18 | Sention Investigational Site | Jefferson City | Missouri | United States | 65109 |
| 19 | Sention Investigational Site | Staten Island | New York | United States | 10301 |
| 20 | Sention Investigational Site | Cary | North Carolina | United States | 27518 |
| 21 | Sention Investigational Site | Greenville | North Carolina | United States | 27834 |
| 22 | Sention Investigational Site | Hickory | North Carolina | United States | 28601 |
| 23 | Sention Investigational Site | Morehead City | North Carolina | United States | 28557 |
| 24 | Sention Investigational Site | Raleigh | North Carolina | United States | 27609 |
| 25 | Sention Investigational Site | Rocky Mount | North Carolina | United States | 27804 |
| 26 | Sention Investigational Site | Salisbury | North Carolina | United States | 28144 |
| 27 | Sention Investigational Site | Wilmington | North Carolina | United States | 28401 |
| 28 | Sention Investigational Site | Mount Pleasant | South Carolina | United States | 29464 |
| 29 | Sention Investigational Site | Bristol | Tennessee | United States | 37620 |
| 30 | Sention Investigational Site | Chattanooga | Tennessee | United States | 37411 |
| 31 | Sention Investigational Site | Memphis | Tennessee | United States | 38133 |
| 32 | Sention Investigational Site | Austin | Texas | United States | 78731 |
| 33 | Sention Investigational Site | Austin | Texas | United States | 78749 |
| 34 | Sention Investigational Site | Benbrook | Texas | United States | 76132 |
| 35 | Sention Investigational Site | Live Oak | Texas | United States | 78233 |
| 36 | Sention Investigational Site | Round Rock | Texas | United States | 78681 |
| 37 | Sention Investigational Site | Webster | Texas | United States | 77598 |
| 38 | Sention Investigational Site | Virginia Beach | Virginia | United States | 23462 |
| 39 | Sention Investigational Site | Renton | Washington | United States | 98057 |
Sponsors and Collaborators
- Sention Therapeutics, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sention Therapeutics, LLC
ClinicalTrials.gov Identifier:
NCT05412979
Other Study ID Numbers:
- ST-1891-201
First Posted:
Jun 9, 2022
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: