T4/T3 Therapy in Hypothyroidism (NCT07424183) | Clinical Trial Compass
Not Yet RecruitingPhase 2
T4/T3 Therapy in Hypothyroidism
United States60 participantsStarted 2026-06
Plain-language summary
This study will test whether 6 months of combination therapy with levothyroxine (LT4) plus liothyronine (LT3) is superior to LT4 plus placebo in participants with hypothyroidism who have residual symptoms of hypothyroidism with TSH levels within the reference range.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female, aged 18-70 years
✓. Hypothyroidism due to either thyroid failure or total thyroidectomy for structural thyroid disease (nodules, benign goiter, or thyroid cancer) for at least 6 months
✓. 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
✓. TSH of 0.5 to 4.0 mU/L within 2 months of enrollment
✓. Persistent symptoms for at least 2 months, and a TSQ score of ≥ 5
✓. 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
✕. 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
✕. Diseases of the pituitary or hypothalamus
✕. History of thyroid cancer requiring suppression of TSH secretion
✕. Unstable cardiac conditions, including uncontrolled hypertension (current blood pressure greater than 160/100), arrhythmia, or angina