Novel Approaches to the Treatment of Hypothyroidism

Launched by UCONN HEALTH · Dec 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying new treatment options for people with hypothyroidism, a condition where the thyroid gland does not produce enough hormones. The study aims to find out if combining two types of thyroid medication—levothyroxine and liothyronine—can be a safe and effective way to manage hypothyroidism. Researchers are particularly interested in how this combination might improve quality of life for patients who may not feel fully better with standard treatment.

To participate in the trial, individuals should be between 65 and 74 years old and have a history of hypothyroidism currently being treated with levothyroxine. However, some people may not qualify if they weigh less than 50 kg or more than 100 kg, are pregnant or breastfeeding, have uncontrolled diabetes, or are taking certain other medications. Participants in the study can expect to receive one of three treatment regimens in a double-blind setup, meaning neither they nor the researchers will know which treatment they are getting. This trial is currently recruiting participants, and it aims to lay the groundwork for larger studies in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • History of hypothyroidism Treatment with levothyroxine Levothyroxine dose \>1.2 mcg/kg
• Exclusion Criteria:
• • 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.