Millions of Americans, particularly women older than 60, live with hypothyroidism. It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.
For today's trial rundown on Hypothyroidism, we identified United States-based trials that are currently recruiting and those that concluded within the past year.
Quick View Table of Hypothyroidism Clinical Trials
| Study Title | Phase | Recruiting? | Enrollment | Start Date | Completion Date |
|---|---|---|---|---|---|
| Novel Approaches to the Treatment of Hypothyroidism | 2,3 | Yes | 90 (estimated) | December 2024 | June 2028 (estimated) |
| A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants | 2,3 | Yes | 2800 (estimated) | April 2024 | June 2028 (estimated) |
| Dosing of LT4 in Older Individuals (DOT4) | 4 | Yes | 228 (estimated) | January 2024 | April 2028 (estimated) |
| A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism | 2 | No | 303 | February 2023 | September 2025 |
Phase 3 Clinical Trials
Novel Approaches to the Treatment of Hypothyroidism
- Sponsor: UConn Health
- Goal: 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 [researchers] 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.
- Interventions: Levothyroxine, levothyroxine/liothyronine once daily, levothyroxine/liothyronine twice daily
- Primary Outcome Measures: Changes in total cholesterol; Changes in LDL cholesterol.
- Time Frames: Six months; Six months.
- Study Details
- Source
A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants
- Sponsor: AbbVie
- Goal: This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone [TSH]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy.
- Interventions: Armour Thyroid, levothyroxine
- Primary Outcome Measures: Percentage of participants who achieve thyroid-stimulating hormone (TSH) response; Number of participants with adverse events (AEs).
- Time Frames: Week 55; Up to approximately 90 weeks.
- Study Details
- Source
Dosing of LT4 in Older Individuals (DOT4)
- Sponsor: University of Pennsylvania
- Goal: [The] overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.
- Interventions: Levothyroxine sodium
- Primary Outcome Measure: Thyroid-related quality of life patient-reported outcome quality of life scale
- Time Frame: Six months
- Study Details
- Source
A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism
- Sponsor: Neuvosyn Laboratories
- Goal: To evaluate the safe and effective dose conversion from Levothyroxine to North Star therapy.
- Interventions: North Star, levothyroxine
- Primary Outcome Measure: The ratio of the LT4 dose (mcg/day) at screening to North Star (mg/day) at the end of the treatment period required to achieve and maintain serum thyroid-stimulating hormone (TSH) levels within the normal reference range
- Time Frame: Week 30
- Study Details
- Source
Related Guidelines:
- Treatment of Hypothyroidism
- American Thyroid Association, December 2014
- Hypothyroidism in Adults
- American Association of Clinical Endocrinologists / American Thyroid Association, December 2012
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