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Not yet recruiting Phase 2 NCT07424183

T4/T3 Therapy in Hypothyroidism

Phase 2 – studying effectiveness and dosage
Conditions: Hypothyroidism Primary

Sponsor: University of Pennsylvania

trial.available_in: БГ
Overview
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.
Description
.Participants will * Take LT4+LT3 or LT4+placebo for 6 months * Visit the clinic at the beginning and the end of the study for a blood test and to answer questionnaires. * Have blood tests checked at 6 and 13 weeks and symptom checks by text (weekly to monthly)
Who can participate
Inclusion Criteria: 1. Male or female, aged 18-70 years 2. Hypothyroidism due to either thyroid failure or total thyroidectomy for structural thyroid disease (nodules, benign goiter, or thyroid cancer) for at least 6 months 3. 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 4. TSH of 0.5 to 4.0 mU/L within 2 months of enrollment 5. Persistent symptoms for at least 2 months, and a TSQ score of ≥ 5 6. 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: 1. 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 2. Diseases of the pituitary or hypothalamus 3. History of thyroid cancer requiring suppression of TSH secretion 4. Unstable cardiac conditions, including uncontrolled hypertension (current blood pressure greater than 160/100), arrhythmia, or angina 5. Uncontrolled psychiatric disorders 6. Pregnancy or lactation, or planned pregnancy within the next 7 months 7. History of food dye allergies 8. GFR \<30 ml/min/1.73 m2 9. 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)
Interventions
Liothyronine (L-T3)
DRUG
Levothyroxine Sodium (LT4) Tablets
DRUG
Liothyronine (LT3) placebo
DRUG
Locations 1
United States (1)
Penn Medicine, Smilow Center for Translational Resarch,
Philadelphia , Pennsylvania
Technical details
Status
Not yet recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
01.06.2027
Registry ID
NCT07424183
Source
clinicaltrials.gov
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