Novel Approaches to the Treatment of Hypothyroidism

NCT06731764 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 24-186-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothyroidism

Outcome Measures

Primary Outcomes (2)

• Changes in Total Cholesterol

  Changes between groups

  6 month

• Changes in LDL Cholesterol

  Changes between groups

  6 month

Secondary Outcomes (1)

• Changes in Weight

  6 month

Study Arms (3)

Levothyroxine alone

ACTIVE COMPARATOR

Patients in this arm will be administered Levothyroxine/Placebo

Drug: Levothyroxine

Combination therapy liothyronine once daily

EXPERIMENTAL

Patients in the arm will be administered Levothyroxine/Liothyronine with Liothyronine administered once daily plus placebo

Drug: Levothyroxine; Drug: Levothyroxine/Liothyronine once daily

Combination therapy liothyronine twice daily

EXPERIMENTAL

Patients in this arm will be administered Levothyroxine/Liothyronine with Liothyronine administered twice daily.

Drug: Levothyroxine; Drug: Levothyroxine/Liothyronine twice daily

Interventions

Levothyroxine DRUG

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

Also known as: LT4

Combination therapy liothyronine once daily; Combination therapy liothyronine twice daily; Levothyroxine alone

Levothyroxine/Liothyronine once daily DRUG

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

Also known as: LT4/LT3

Combination therapy liothyronine once daily

Levothyroxine/Liothyronine twice daily DRUG

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

Also known as: LT4/LT3

Combination therapy liothyronine twice daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of hypothyroidism Treatment with levothyroxine Levothyroxine dose \>1.2 mcg/kg

You may not qualify if:

• 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.

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

RECRUITING

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Francesco Celi

  UConn Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco S Celi, MD, MHSc.

CONTACT

(860) 679-2715; celi@uchc.edu

Nicole Glidden

CONTACT

(860) 679-4647; DOMClinicalResearch@uchc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)