New thyroid drug shows promise in phase 2 trial

NCT ID NCT05712421

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

303 people

The number who actually took part.

Started

Feb 2023

Finished

Sep 2025

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 * 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

  • Neuvosyn Investigational Site

    Birmingham, Alabama, 35209, United States

  • Neuvosyn Investigational Site

    Canoga Park, California, 91304, United States

  • Neuvosyn Investigational Site

    Greenbrae, California, 94904, United States

  • Neuvosyn Investigational Site

    Toluca Lake, California, 91602, United States

  • Neuvosyn Investigational Site

    Farmington, Connecticut, 06030, United States

  • Neuvosyn Investigational Site

    Boca Raton, Florida, 33434, United States

  • Neuvosyn Investigational Site

    Miami, Florida, 33144, United States

  • Neuvosyn Investigational Site

    Miami, Florida, 33145, United States

  • Neuvosyn Investigational Site

    Miami, Florida, 33155, United States

  • Neuvosyn Investigational Site

    Miami, Florida, 33174, United States

  • Neuvosyn Investigational Site

    Miami, Florida, 33179, United States

  • Neuvosyn Investigational Site

    Sunrise, Florida, 33351, United States

  • Neuvosyn Investigational Site

    Acworth, Georgia, 30101, United States

  • Neuvosyn Investigational Site

    Atlanta, Georgia, 30318, United States

  • Neuvosyn Investigational Site

    Columbus, Georgia, 31904, United States

  • Neuvosyn Investigational Site

    Sugar Hill, Georgia, 30024, United States

  • Neuvosyn Investigational Site

    Saginaw, Michigan, 48602, United States

  • Neuvosyn Investigational Site

    Gladstone, Missouri, 64118, United States

  • Neuvosyn Investigational Site

    Williamsville, New York, 14221, United States

  • Neuvosyn Investigational Site

    Denver, North Carolina, 28037, United States

  • Neuvosyn Investigational Site

    Winston-Salem, North Carolina, 27103, United States

  • Neuvosyn Investigational Site

    Beavercreek, Ohio, 45440, United States

  • Neuvosyn Investigational Site

    Columbus, Ohio, 31904, United States

  • Neuvosyn Investigational Site

    Georgetown, Texas, 78628, United States

  • Neuvosyn Investigational Site

    Houston, Texas, 77040, United States

  • Neuvosyn Investigational Site

    Katy, Texas, 77450, United States

  • Neuvosyn Investigational Site

    Katy, Texas, 77494, United States

  • Neuvosyn Investigational Site

    Lewisville, Texas, 75067, United States

  • Neuvosyn Investigational Site

    Paris, Texas, 75462, United States

  • Neuvosyn Investigational Site

    Pearland, Texas, 77584, United States

  • Neuvosyn Investigational Site

    Stafford, Texas, 77477, United States

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Other studies related to the condition(s) this trial covers.