NCT06731764 Novel Approaches to the Treatment of Hypothyroidism
| NCT ID | NCT06731764 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | UConn Health |
| Condition | Hypothyroidism |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2024-12-10 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Francesco Celi
PRINCIPAL INVESTIGATOR
UConn Health
Frequently Asked Questions
Who can join the NCT06731764 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypothyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06731764 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06731764 currently recruiting?
Yes, NCT06731764 is actively recruiting participants. Contact the research team at celi@uchc.edu for enrollment information.
Where is the NCT06731764 trial being conducted?
This trial is being conducted at Farmington, United States.
Who is sponsoring the NCT06731764 clinical trial?
NCT06731764 is sponsored by UConn Health. The principal investigator is Francesco Celi at UConn Health. The trial plans to enroll 90 participants.