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Novel Approaches to the Treatment of Hypothyroidism

NCT06731764 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Levothyroxine

Patients will receive Levothyroxine/Placebo Levothyroxine/Liothyronine with Liothyronine administered twice daily.

DRUG

Levothyroxine/Liothyronine once daily

Patients will receive Levothyroxine/Liothyronine with Liothyronine administered once daily;

DRUG

Levothyroxine/Liothyronine twice daily

Patients will receive Levothyroxine/Liothyronine with Liothyronine administered twice daily;

Sponsors & Collaborators

  • UConn Health

    lead OTHER

Principal Investigators

  • Francesco Celi · UConn Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2027-12-31
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06731764 on ClinicalTrials.gov