Actively Recruiting
Novel Approaches to the Treatment of Hypothyroidism Randomized Pilot Study of Levothyroxine and Liothyronine Combination Therapy
Led by UConn Health · Updated on 2026-03-19
90
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hypothyroidism is a common condition that increases cardiovascular risk and often reduces quality of life even with standard levothyroxine treatment. Researchers are investigating whether combining levothyroxine (LT4) with liothyronine (LT3) can better restore thyroid hormone levels and improve health outcomes. This study addresses the need to find a safe, effective dosing regimen for LT4/LT3 combination therapy through a controlled, randomized pilot trial. Participants will be randomly assigned to one of three groups: levothyroxine alone, levothyroxine combined with liothyronine once daily, or levothyroxine combined with liothyronine twice daily. The study lasts six months, during which drug doses may escalate as part of the protocol. The trial is double-blind and controlled to compare these treatment approaches rigorously. During the study, participants will undergo regular assessments including blood tests to measure cholesterol levels and weight changes. Researchers will monitor treatment effects and safety throughout the six months. The main outcomes are changes in total cholesterol and LDL cholesterol, with secondary outcomes including weight changes. This pilot study aims to inform larger trials evaluating LT4/LT3 combination therapy for hypothyroidism.
CONDITIONS
Brief 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 action
- History of bariatric surgery or initiation of GLP-1 agonist therapy
- Enrollment in structured weight loss programs
- Planned pregnancy or lack of contraception in women of reproductive age
- Any participant who becomes pregnant during the study will be withdrawn immediately from the trial and treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants are randomized to receive Levothyroxine alone, Levothyroxine/Liothyronine once daily, or Levothyroxine/Liothyronine twice daily for six months.
Regular visits throughout treatment as per protocol
Trial Site Locations
Total: 1 location
1
UConn Health
Farmington, Connecticut, United States, 06030
Actively Recruiting
Research Team
F
Francesco S Celi, MD, MHSc.
N
Nicole Glidden
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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