New treatment options for hypothyroidism

Novel Approaches to the Treatment of Hypothyroidism

This study is testing a new combination of two thyroid medications to see if it can help people with hypothyroidism feel better.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: UConn Health (other)
• Locations: 1 site (Farmington, Connecticut)
• Trial ID: NCT06731764 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a combination therapy using levothyroxine and liothyronine for patients with hypothyroidism. It is a randomized, three-arm, double-blind, controlled study designed to assess different dosing regimens of the combination therapy. The goal is to establish a safe and effective treatment regimen that can be used in larger trials to evaluate the efficacy of this approach. The study aims to address the limitations of current treatments that do not fully alleviate symptoms and risks associated with hypothyroidism.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with a history of hypothyroidism who are currently being treated with levothyroxine at a dose greater than 1.2 mcg/kg.

Not a fit: Patients who may not benefit from this study include those with secondary hypothyroidism, pregnant or breastfeeding individuals, and those with uncontrolled diabetes or hypertension.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from hypothyroidism, potentially improving their quality of life and reducing cardiovascular risks.

How similar studies have performed: Previous studies on levothyroxine/liothyronine combination therapy have shown mixed results, indicating that this approach is still being explored and has not yet reached a consensus on its effectiveness.

Eligibility criteria

Inclusion Criteria:

History of hypothyroidism Treatment with levothyroxine Levothyroxine dose \>1.2 mcg/kg

Exclusion Criteria:

Body weight \<50 or \>100 Kg.

Indication for TSH suppression (high risk follicular-derived thyroid cancer).

Secondary (pituitary) hypothyroidism (ICD-10 E23.0); Pregnancy; breastfeeding; uncontrolled diabetes (HbA1c \>8.5% at screening); use of oral Semaglutide (Rybelsus); Uncontrolled Hypertension (BP \> 140/90 at screening); current use of T3-containing therapies (Liothyronine, desiccated thyroid extracts).

Patients receiving lipid-lowering therapies must maintain the same dose throughout the participation in the study. Changes in lipid lowering therapy/dose will result in termination from the study.

Patients receiving anti-acid (H2 blockers, proton pump inhibitors) therapies must maintain the same dose throughout the participation in the study. Changes in anti-acid therapy/dose will result in termination from the study. Use of other medications known to interfere with the absorption of thyroid hormone, or affecting the thyroid hormone axis (Burch 2019) will be considered exclusion criteria.

Bariatric surgery, initiation of GLP-1 agonist therapy (irrespective of the indication), enrollment in structured weight loss programs will result in dismissal from the study.

Current pregnancy, pregnancy planned within the next 6 months, and lack of contraception in women of reproductive age will be exclusionary. We will verify that the participant is not pregnant through a urine pregnancy test at the time of the first study visit and at each of the follow-up visits. Any participants who become pregnant will terminate the study.

Where this trial is running

Farmington, Connecticut

• UConn Health — Farmington, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Francesco Celi — UConn Health
• Study coordinator: Francesco S Celi, MD, MHSc.

Conditions: Hypothyroidism