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Thyroid Hormone Combination Therapy
Novel Treatments for Hypothyroidism
Phase 2 & 3
Recruiting
Led By Francesco Celi
Research Sponsored by UConn Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of hypothyroidism
Levothyroxine dose >1.2 mcg/kg
Must not have
Current use of T3-containing therapies (Liothyronine, desiccated thyroid extracts)
Body weight <50 or >100 Kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to find a better treatment for hypothyroidism, a common condition that affects more females and is linked to heart risks and poor quality of life even with current treatment. The study will
Who is the study for?
This trial is for individuals with hypothyroidism, particularly more common in females. It aims to find a better treatment regimen than the current standard. Participants should be willing to try new combinations of thyroid medications and adhere to the study protocol.
What is being tested?
The study tests three different treatments: standard Levothyroxine, a combination of Levothyroxine/Liothyronine taken once daily, and the same combination taken twice daily. The goal is to determine which regimen improves quality of life and reduces cardiovascular risks.
What are the potential side effects?
Potential side effects may include changes in heart rate, weight fluctuations, fatigue, anxiety or mood swings due to altered thyroid hormone levels. Side effects will vary depending on individual response to medication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a history of hypothyroidism.
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I take more than 1.2 mcg/kg of Levothyroxine daily.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication that contains T3.
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My weight is either below 50 kg or above 100 kg.
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I have been diagnosed with a specific thyroid condition caused by the pituitary gland.
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My diabetes is not under control (HbA1c >8.5%).
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I am taking Rybelsus.
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I need treatment to lower my thyroid hormone levels due to high-risk thyroid cancer.
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My blood pressure is not higher than 140/90.
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I am on a stable dose of lipid-lowering medication.
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I am taking anti-acid medication and can keep the dose the same during the study.
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I am not taking medications that affect thyroid hormone absorption or function.
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I have not had bariatric surgery, started GLP-1 agonist therapy, or joined a weight loss program recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in LDL Cholesterol
Changes in Total Cholesterol
Secondary study objectives
Changes in Weight
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Combination therapy liothyronine twice dailyExperimental Treatment2 Interventions
Patients in this arm will be administered Levothyroxine/Liothyronine with Liothyronine administered twice daily.
Group II: Combination therapy liothyronine once dailyExperimental Treatment2 Interventions
Patients in the arm will be administered Levothyroxine/Liothyronine with Liothyronine administered once daily plus placebo
Group III: Levothyroxine aloneActive Control1 Intervention
Patients in this arm will be administered Levothyroxine/Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levothyroxine
2013
Completed Phase 4
~3840
Find a Location
Who is running the clinical trial?
UConn HealthLead Sponsor
215 Previous Clinical Trials
60,631 Total Patients Enrolled
Francesco CeliPrincipal InvestigatorUConn Health