Actively Recruiting
Novel Approaches to the Treatment of Hypothyroidism
Led by UConn Health · Updated on 2026-03-19
90
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Novel Approaches to the Treatment of Hypothyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of hypothyroidism
- Treatment with levothyroxine
- Levothyroxine dose greater than 1.2 mcg/kg
You will not qualify if you...
- Body weight less than 50 or greater than 100 kilograms
- Need for TSH suppression due to high risk follicular-derived thyroid cancer
- Secondary (pituitary) hypothyroidism
- Pregnancy or breastfeeding
- Uncontrolled diabetes with HbA1c greater than 8.5% at screening
- Use of oral Semaglutide (Rybelsus)
- Uncontrolled hypertension with blood pressure over 140/90 at screening
- Current use of T3-containing therapies such as liothyronine or desiccated thyroid extracts
- Changes in lipid-lowering or anti-acid therapies during the study
- Use of medications interfering with thyroid hormone absorption or axis
- History of bariatric surgery or recent initiation of GLP-1 agonist therapy
- Enrollment in structured weight loss programs
- Lack of contraception in women of reproductive age
AI-Screening
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Trial Site Locations
Total: 1 location
1
UConn Health
Farmington, Connecticut, United States, 06030
Actively Recruiting
Research Team
F
Francesco S Celi, MD, MHSc.
CONTACT
N
Nicole Glidden
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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