New thyroid drug shows promise in phase 2 trial
NCT ID NCT05712421
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study tested a new hormone replacement therapy called North Star against the standard drug levothyroxine in 303 adults with hypothyroidism. The goal was to find the right dose of North Star to keep thyroid hormone levels normal. Participants were already stable on levothyroxine and were switched to North Star to see if it worked as well.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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303 people
The number who actually took part.
- Started
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Feb 2023
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosed with primary hypothyroidism * On continuous thyroid replacement therapy for at least 6 months before Study Entry * On a stable daily dose of LT4 for a minimum of 12 weeks prior to Screening * Agree to practice a method of contraception * Female patients not pregnant or lactating at Screening * Agree to practice a method of contraception of greater than 90% reliability * Willing to give written informed consent for the Study * Provide written authorization for use and disclosure of protected health information Exclusion Criteria: * Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of North Star or levothyroxine * Hospitalization for a major illness within 4 weeks prior to Screening * Anticipated initiation or change in concomitant medications * Concomitant use of prohibited medications or supplements * Participated in another investigational new drug study within 30 days or 5 half-lives of the IMP, whichever is longer, prior to the first study drug administration. * For female subjects, be pregnant, nursing or planning to become pregnant during the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Neuvosyn Investigational Site
Birmingham, Alabama, 35209, United States
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Neuvosyn Investigational Site
Canoga Park, California, 91304, United States
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Neuvosyn Investigational Site
Greenbrae, California, 94904, United States
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Neuvosyn Investigational Site
Toluca Lake, California, 91602, United States
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Neuvosyn Investigational Site
Farmington, Connecticut, 06030, United States
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Neuvosyn Investigational Site
Boca Raton, Florida, 33434, United States
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Neuvosyn Investigational Site
Miami, Florida, 33144, United States
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Neuvosyn Investigational Site
Miami, Florida, 33145, United States
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Neuvosyn Investigational Site
Miami, Florida, 33155, United States
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Neuvosyn Investigational Site
Miami, Florida, 33174, United States
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Neuvosyn Investigational Site
Miami, Florida, 33179, United States
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Neuvosyn Investigational Site
Sunrise, Florida, 33351, United States
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Neuvosyn Investigational Site
Acworth, Georgia, 30101, United States
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Neuvosyn Investigational Site
Atlanta, Georgia, 30318, United States
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Neuvosyn Investigational Site
Columbus, Georgia, 31904, United States
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Neuvosyn Investigational Site
Sugar Hill, Georgia, 30024, United States
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Neuvosyn Investigational Site
Saginaw, Michigan, 48602, United States
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Neuvosyn Investigational Site
Gladstone, Missouri, 64118, United States
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Neuvosyn Investigational Site
Williamsville, New York, 14221, United States
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Neuvosyn Investigational Site
Denver, North Carolina, 28037, United States
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Neuvosyn Investigational Site
Winston-Salem, North Carolina, 27103, United States
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Neuvosyn Investigational Site
Beavercreek, Ohio, 45440, United States
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Neuvosyn Investigational Site
Columbus, Ohio, 31904, United States
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Neuvosyn Investigational Site
Georgetown, Texas, 78628, United States
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Neuvosyn Investigational Site
Houston, Texas, 77040, United States
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Neuvosyn Investigational Site
Katy, Texas, 77450, United States
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Neuvosyn Investigational Site
Katy, Texas, 77494, United States
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Neuvosyn Investigational Site
Lewisville, Texas, 75067, United States
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Neuvosyn Investigational Site
Paris, Texas, 75462, United States
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Neuvosyn Investigational Site
Pearland, Texas, 77584, United States
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Neuvosyn Investigational Site
Stafford, Texas, 77477, United States
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Other studies related to the condition(s) this trial covers.
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