Novel Approaches to the Treatment of Hypothyroidism
UConn Health
90 participants
Dec 10, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- History of hypothyroidism Treatment with levothyroxine Levothyroxine dose \>1.2 mcg/kg
Exclusion Criteria6
- 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.
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients will receive Levothyroxine/Placebo Levothyroxine/Liothyronine with Liothyronine administered twice daily.
Patients will receive Levothyroxine/Liothyronine with Liothyronine administered once daily;
Patients will receive Levothyroxine/Liothyronine with Liothyronine administered twice daily;
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06731764