Can a pig thyroid extract tame hypothyroidism?
NCT ID NCT07747103
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This Phase 3 trial is testing an experimental tablet made from desiccated porcine thyroid extract, called North Star, in people with primary hypothyroidism. The study aims to see if this treatment can bring thyroid-stimulating hormone (TSH) levels into the normal range. Participants will take the extract and be monitored for safety and effectiveness over 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Desiccated porcine thyroid extract tablets (North Star)
- What this could lead to
- If successful, this could offer an alternative treatment option for people with primary hypothyroidism who need thyroid hormone replacement.
- What could go wrong
- This is an open-label, single-arm study, so results may be influenced by bias and lack a comparison group. The extract may not consistently control TSH levels or could cause side effects.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 466 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- 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, including Hashimoto's Thyroiditis, and on therapy with a stable dose of LT4 (minimum 50 mcg per day, administered 7 days per week) for at least 12 weeks prior to Screening * Have had euthyroid status for at least 6 weeks and up to 12 months prior to Screening (Visit 1), with at least one documented minimum stable dose of 50 mcg LT4. * 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 * Hospitalization for a major illness within 5 weeks prior to Screening * Concomitant use of prohibited medications or supplements * Have uncontrolled diabetes * Taking or having taken prescription or over-the-counter weight loss medications within 6 weeks prior to Screening * 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
25 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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3Sync LLC
NOT_YET_RECRUITINGMiami Lakes, Florida, 33014, United States
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3Sync Research
NOT_YET_RECRUITINGPalm Springs, Florida, 33461, United States
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Accel Research
NOT_YET_RECRUITINGLakeland, Florida, 33803, United States
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Accel Research
NOT_YET_RECRUITINGLargo, Florida, 33777, United States
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ActivMed Practices and Research
NOT_YET_RECRUITINGMethuen, Massachusetts, 01844, United States
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Advanced Medical Research Institute, LLC
RECRUITINGMiami, Florida, 33147, United States
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Advanced Medical Trials, LLC
NOT_YET_RECRUITINGGeorgetown, Texas, 78628, United States
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AppleMed Research Group, LLC
RECRUITINGMiami, Florida, 33126, United States
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Boston Clinical Trials
NOT_YET_RECRUITINGBoston, Massachusetts, 02131, United States
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Charlotteville Medical Research Center, LLC
NOT_YET_RECRUITINGCharlottesville, Virginia, 22911, United States
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Coastal Carolina Research Center, LLC
NOT_YET_RECRUITINGNorth Charleston, South Carolina, 29405, United States
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M3 Wake Research
NOT_YET_RECRUITINGRaleigh, North Carolina, 27612, United States
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M3 Wake Research
NOT_YET_RECRUITINGCharleston, South Carolina, 29414, United States
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M3 Wake Research
NOT_YET_RECRUITINGChattanooga, Tennessee, 37421, United States
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M3 Wake Research
NOT_YET_RECRUITINGDallas, Texas, 75246, United States
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M3 Wake Research - Las Vegas Wellness Way
NOT_YET_RECRUITINGLas Vegas, Nevada, 89106, United States
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Olympus Clinical Research
NOT_YET_RECRUITINGSugar Land, Texas, 77478, United States
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Paradigm Clinical Research Centers, LLC
NOT_YET_RECRUITINGModesto, California, 95355, United States
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Paradigm Clinical Research Centers, LLC
NOT_YET_RECRUITINGRedding, California, 96001, United States
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Paradigm Clinical Research Centers, LLC
NOT_YET_RECRUITINGSan Diego, California, 92108, United States
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Paradigm Clinical Research Centers, LLC
NOT_YET_RECRUITINGAurora, Colorado, 80012, United States
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Paradigm Clinical Research Centers, LLC
NOT_YET_RECRUITINGBoise, Idaho, 83709, United States
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Precision Clinical Research
NOT_YET_RECRUITINGSunrise, Florida, 33351, United States
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Progressive Medicine of the Triad, LLC
NOT_YET_RECRUITINGWinston-Salem, North Carolina, 27103, United States
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Sunwise Clinical Research
NOT_YET_RECRUITINGWalnut Creek, California, 94596, United States
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Other studies related to the condition(s) this trial covers.
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