Novel Approaches to the Treatment of Hypothyroidism

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
UConn Health
Study ID
NCT06731764
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Hypothyroidism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Levothyroxine — DRUG
    Patients will receive Levothyroxine/Placebo Levothyroxine/Liothyronine with Liothyronine administered twice daily.
  • Levothyroxine/Liothyronine once daily — DRUG
    Patients will receive Levothyroxine/Liothyronine with Liothyronine administered once daily;
  • Levothyroxine/Liothyronine twice daily — DRUG
    Patients will receive Levothyroxine/Liothyronine with Liothyronine administered twice daily;

Study Details

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.

Key Dates

Start date
Dec 10, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Levothyroxine alone
    Patients in this arm will be administered Levothyroxine/Placebo
  • Experimental: Combination therapy liothyronine once daily
    Patients in the arm will be administered Levothyroxine/Liothyronine with Liothyronine administered once daily plus placebo
  • Experimental: Combination therapy liothyronine twice daily
    Patients in this arm will be administered Levothyroxine/Liothyronine with Liothyronine administered twice daily.

Primary Outcome Measure

Changes in Total Cholesterol [ Time Frame: 6 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UConn HealthFarmingtonConnecticut06030
Nicole Glidden
[email protected]
(860) 679-4647
Jenny Derouen
[email protected]
(860) 679-4647

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By research site
UConn Health· Farmington, CT

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