Novel Approaches to the Treatment of Hypothyroidism

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Hypothyroidism

In brief

Hypothyroidism is a common condition, more frequent in females, associated with excess of cardiovascular risk and poor quality of life not completely abrogated by treatment with levothyroxine. There is an unmet need to define a safe, effective, and feasible regimen to be applied in large trials aimed at assessing levothyroxine/liothyronine combination therapy in patients living with hypothyroidism. To address this knowledge gap we propose a randomized, three-arm, double-blind, controlled, escalating dose parallel pilot study whose results will lay the foundation of large multicenter trial(s) able to demonstrate the effectiveness (or lack thereof) of levothyroxine/liothyronine combination therapy.

Key facts

Study ID

NCT06731764

Run by

UConn Health

People needed

90

Starts

2024-12-10

Expected to finish

2028-06-30

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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