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Could a second thyroid hormone end lingering fatigue?

NCT ID NCT07424183

Symptom relief Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests whether adding a second thyroid hormone (T3) to the standard T4 treatment can improve persistent symptoms like fatigue and brain fog in people with hypothyroidism. It involves 60 adults aged 18-70 who still have symptoms despite normal thyroid blood tests. Participants will receive either T4 plus T3 or T4 plus a placebo for 6 months, and their quality of life and symptom changes will be measured.

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

About 60 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 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: 1. Male or female, aged 18-70 years 2. Hypothyroidism due to either thyroid failure or total thyroidectomy for structural thyroid disease (nodules, benign goiter, or thyroid cancer) for at least 6 months 3. Taking 75-150 mcg per day LT4 and a minimum of 1.2 mcg/kg/day, with stable dose of LT4 for at least 3 months prior to enrollment 4. TSH of 0.5 to 4.0 mU/L within 2 months of enrollment 5. Persistent symptoms for at least 2 months, and a TSQ score of ≥ 5 6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study intervention. Exclusion Criteria: 1. Current use of LT3, thyroid extracts, Tirosint liquid or capsules, amiodarone, lithium, methimazole, propylthiouracil, supraphysiologic doses of corticosteroids, immunotherapy, tyrosine kinase inhibitors, interferon, or biotin supplements 2. Diseases of the pituitary or hypothalamus 3. History of thyroid cancer requiring suppression of TSH secretion 4. Unstable cardiac conditions, including uncontrolled hypertension (current blood pressure greater than 160/100), arrhythmia, or angina 5. Uncontrolled psychiatric disorders 6. Pregnancy or lactation, or planned pregnancy within the next 7 months 7. History of food dye allergies 8. GFR \<30 ml/min/1.73 m2 9. Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study (for example, end-stage cancer)

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Conditions

The condition(s) this trial relates to.

hypothyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypothyroidism primary

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • Penn Medicine, Smilow Center for Translational Resarch,

    Philadelphia, Pennsylvania, 19104, United States

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