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Not yet recruiting NCT07424183

T4/T3 Therapy in Hypothyroidism

Phase II Interventional Hypothyroidism Primary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liothyronine (L-T3), Levothyroxine Sodium (LT4) Tablets, Liothyronine (LT3) placebo.
Who it may be relevant to
Registry conditions: Hypothyroidism Primary. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Detailed 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)

Interventions

  • Drug Liothyronine (L-T3)
    Participants will either take LT3 with an LT4 dose that is reduced from baseline or they will take liothyronine placebo with their baseline LT4 dose.
  • Drug Levothyroxine Sodium (LT4) Tablets
    All participants will take levothyroxine.
  • Drug Liothyronine (LT3) placebo
    Identical placebo tablet without containing liothyronine

Primary outcome measures

  • ThyPRO Composite QOL Scale [Time frame: 6 months]
Secondary outcome measures (10)
  • ThyPRO subscales [Time frame: 6 months]
  • Thyroid Symptoms Questionnaire (TSQ) [Time frame: 6 months]
  • Cognitive measures [Time frame: Baseline and 6 months]
  • Beck Depression Inventory [Time frame: Baseline and 6 months]
  • Beck Anxiety Inventory [Time frame: Baseline and 6 months]
  • Pittsburgh Sleep Quality Index [Time frame: 6 months]
  • Weight [Time frame: 6 months]
  • LDL cholesterol [Time frame: 6 months]
  • Serum c-telopeptide [Time frame: 6 months]
  • Satisfaction with randomized status [Time frame: 6 months]

Eligibility criteria

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
  • Uncontrolled psychiatric disorders
  • Pregnancy or lactation, or planned pregnancy within the next 7 months
  • History of food dye allergies
  • GFR <30 ml/min/1.73 m2
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Penn Medicine, Smilow Center for Translational Resarch, — Philadelphia

Identifiers

NCT: NCT07424183 · 10094647 · R01DK137207

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗