Thyroid pill plus diet may boost weight loss in obesity, new trial suggests
NCT ID NCT07332273
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
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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 286 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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25 to 60 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: * 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.
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The places running it
5 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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Hospital Clínico Universitario de Valladolid
NOT_YET_RECRUITINGValladolid, Spain
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Hospital Puerta del Mar
NOT_YET_RECRUITINGCadiz, Spain
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Hospital Reina Sofía
NOT_YET_RECRUITINGCórdoba, Spain
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Hospital Universitario Virgen de la Victoria
RECRUITINGMálaga, Spain
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Hospital Universitario de Jaén
NOT_YET_RECRUITINGJaén, Spain
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