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Thyroid pill plus diet may boost weight loss in obesity, new trial suggests

NCT ID NCT07332273

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether adding a low dose of levothyroxine (a thyroid hormone) to a Mediterranean diet and exercise program helps adults with obesity lose more weight and keep it off. The study enrolls 286 people aged 25-60 with grade I-II obesity and higher-than-normal thyroid hormone levels. Participants take either levothyroxine or a placebo daily for 9 months, while all follow the same lifestyle program. Researchers will measure weight, body fat, and metabolic health at 3 and 9 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
levothyroxine (thyroid hormone)
What this could lead to
If it works, this could point toward a new way to boost weight loss and prevent regain in people with obesity who have higher thyroid hormone levels.
What could go wrong
This is still an early-phase trial with 286 people, so results may not apply to everyone. Levothyroxine can cause heart palpitations or bone loss if overused.

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 286 people

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

Started

Nov 2025

Expected to finish

May 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

25 to 60 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: * Adults 25-60 years of age. * Obesity grade I-II: BMI 30.0-39.9 kg/m². * Either subclinical hypothyroidism (TSH 5-10 mIU/L with normal peripheral hormones) or euthyroid with TSH in the highest tertile of the population reference range (no known thyroid disease). * Able and willing to provide written informed consent. * Women of childbearing potential: not pregnant or breastfeeding and using a highly effective contraception method (failure rate \<1%) per CTCG guidance (e.g., hormonal methods, IUD/IUS, sterilization, or dual barrier with spermicide). Exclusion Criteria: * Diabetes mellitus (HbA1c ≥6.5%, fasting glucose ≥126 mg/dL, or 2-h OGTT ≥200 mg/dL). * Any prior thyroid disease (hyperthyroidism, overt hypothyroidism) or prior LT4 treatment. * Current or recent (≤3 months) use of levothyroxine, hypoglycaemic agents, antibiotics, or regular probiotics/prebiotics. * Active cancer or cancer within the last 5 years (except basal-cell carcinoma). * Chronic liver disease with total bilirubin ≥2.0 mg/dL or AST \>3× ULN. * Established cardiovascular disease (e.g., stroke, ischemic heart disease, peripheral artery disease). * Atrial fibrillation or any arrhythmia history. * Uncontrolled hypertension (\>160/100 mmHg) despite therapy (assessed by ABPM at screening). * Any heart failure; resting HR \>85 bpm; eGFR \<60 mL/min. * Known HIV, HBV, or HCV infection. * Acute inflammatory disease or inflammatory bowel disease. * Serious underlying disease that, in the investigator's judgment, could affect participation. * Drug/alcohol abuse, life expectancy \<12 months, inability to follow the recommended diet or attend visits. * Positive pregnancy test, pregnant, expecting pregnancy, or breastfeeding. * Hypersensitivity to any component of the investigational product. * Inability or unwillingness to provide informed consent.

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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

    5 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

  • Hospital Clínico Universitario de Valladolid

    NOT_YET_RECRUITING

    Valladolid, Spain

  • Hospital Puerta del Mar

    NOT_YET_RECRUITING

    Cadiz, Spain

  • Hospital Reina Sofía

    NOT_YET_RECRUITING

    Córdoba, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, Spain

  • Hospital Universitario de Jaén

    NOT_YET_RECRUITING

    Jaén, Spain

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