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Can a pig thyroid extract tame hypothyroidism?

NCT ID NCT07747103

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 466 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    25 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 3Sync LLC

    NOT_YET_RECRUITING

    Miami Lakes, Florida, 33014, United States

  • 3Sync Research

    NOT_YET_RECRUITING

    Palm Springs, Florida, 33461, United States

  • Accel Research

    NOT_YET_RECRUITING

    Lakeland, Florida, 33803, United States

  • Accel Research

    NOT_YET_RECRUITING

    Largo, Florida, 33777, United States

  • ActivMed Practices and Research

    NOT_YET_RECRUITING

    Methuen, Massachusetts, 01844, United States

  • Advanced Medical Research Institute, LLC

    RECRUITING

    Miami, Florida, 33147, United States

  • Advanced Medical Trials, LLC

    NOT_YET_RECRUITING

    Georgetown, Texas, 78628, United States

  • AppleMed Research Group, LLC

    RECRUITING

    Miami, Florida, 33126, United States

  • Boston Clinical Trials

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02131, United States

  • Charlotteville Medical Research Center, LLC

    NOT_YET_RECRUITING

    Charlottesville, Virginia, 22911, United States

  • Coastal Carolina Research Center, LLC

    NOT_YET_RECRUITING

    North Charleston, South Carolina, 29405, United States

  • M3 Wake Research

    NOT_YET_RECRUITING

    Raleigh, North Carolina, 27612, United States

  • M3 Wake Research

    NOT_YET_RECRUITING

    Charleston, South Carolina, 29414, United States

  • M3 Wake Research

    NOT_YET_RECRUITING

    Chattanooga, Tennessee, 37421, United States

  • M3 Wake Research

    NOT_YET_RECRUITING

    Dallas, Texas, 75246, United States

  • M3 Wake Research - Las Vegas Wellness Way

    NOT_YET_RECRUITING

    Las Vegas, Nevada, 89106, United States

  • Olympus Clinical Research

    NOT_YET_RECRUITING

    Sugar Land, Texas, 77478, United States

  • Paradigm Clinical Research Centers, LLC

    NOT_YET_RECRUITING

    Modesto, California, 95355, United States

  • Paradigm Clinical Research Centers, LLC

    NOT_YET_RECRUITING

    Redding, California, 96001, United States

  • Paradigm Clinical Research Centers, LLC

    NOT_YET_RECRUITING

    San Diego, California, 92108, United States

  • Paradigm Clinical Research Centers, LLC

    NOT_YET_RECRUITING

    Aurora, Colorado, 80012, United States

  • Paradigm Clinical Research Centers, LLC

    NOT_YET_RECRUITING

    Boise, Idaho, 83709, United States

  • Precision Clinical Research

    NOT_YET_RECRUITING

    Sunrise, Florida, 33351, United States

  • Progressive Medicine of the Triad, LLC

    NOT_YET_RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Sunwise Clinical Research

    NOT_YET_RECRUITING

    Walnut Creek, California, 94596, United States

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