T4/T3 Therapy in Hypothyroidism
Key facts
- Where
- Philadelphia, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07424183, who can take part
Where in United States
- Penn Medicine, Smilow Center for Translational Resarch,Philadelphia, United StatesContact: Anne R. Cappola, MD, ScMNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Pennsylvania
- Trial code
- NCT07424183
- Record updated
- 20 August 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; Uncontrolled psychiatric disorders; History of food dye allergies; 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); GFR <30 ml/min/1.73 m2; Pregnancy or lactation, or planned pregnancy within the next 7 months.