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New treatment option for Obesity
Official title Levothyroxine as Adjuvant to a Hypocaloric Diet for the Treatment of Obesity.
ClinicalTrials.gov ID: NCT07332273
What this study is testing
What is Levothyroxine?
Levothyroxine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Obesity is a chronic disease with high relapse rates after initial weight loss. Thyroid hormones modulate energy expenditure, body composition, and thermogenesis; higher TSH within the reference range and subclinical hypothyroidism have been associated with adverse metabolic profiles and weight gain.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 60
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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).
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cadiz, Spain
- Córdoba, Spain
- Jaén, Spain
- Málaga, Spain
- Valladolid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cadiz, Spain; Córdoba, Spain; Jaén, Spain; Málaga, Spain; Valladolid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.