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

NCT06345339 · tracked via the Priya Life Science USA tracker

Sponsor

AbbVie

Phase

Phase 2/3

Started

2024-04-26

Last updated

2026-01-05

Condition(s) studied

Hypothyroidism

Investigational drug(s) / intervention(s)

Armour ThyroidLevothyroxine →

Armour Thyroid: Oral Capsule or Tablet

Levothyroxine: Oral Capsule

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Have a diagnosis of primary hypothyroidism made \>= 12 months prior to Screening. * Be on continuous thyroid replacement therapy of synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit. * Be on a stable FDA-approved daily dose of synthetic T4 prior to the Screening visit, and must be taking synthetic T4 dose of at least 25 mcg at Screening visit. Must enter the study using the same stable dose to determine dose conversion. * Documentation of 1 in-range thyroid-stimulating hormone (TSH) (i.e., within 0.45 - 4.12 mIU/L, inclusive) at Screening and at least 1 additional in range TSH (i.e., within 0.45 - 4.12 mIU/L, inclusive) taken at a minimum of 6 weeks and a maximum of 12 months prior to Screening. Exclusion Criteria: * Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of Armour Thyroid or synthetic T4. * History of alcohol or other substance abuse within the previous 6 months prior to the Screening. * Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, synthetic T4, other thyroid replacement medications, or pork products.

Primary outcome measure(s)

Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response — Week 55
TSH response is defined as TSH values falling within 0.45 to 4.12 mIU/L (inclusive). TSH response will be determined at Week 55 and at a prior visit with no out-of-range TSH values in between (response rate is tested against a specified non-inferiority margin).
Number of Participants with Adverse Events (AEs) — Up to approximately 90 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Trial sites (139)

Facility	City	Region	Status
Central Research Associates /ID# 255719	Birmingham	Alabama	Recruiting
UAB Hospital /ID# 262565	Birmingham	Alabama	Recruiting
Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552	Bonita	California	Recruiting
Facey Medical Foundation - Burbank /ID# 262104	Burbank	California	Recruiting
John Muir Medical Center /ID# 257103	Concord	California	Recruiting
Diagnamics Inc. /ID# 262680	Encinitas	California	Recruiting
Providence - St. Jude Medical Center /ID# 256520	Fullerton	California	Recruiting
NorCal Medical Research /ID# 256512	Greenbrae	California	Recruiting
Velocity Clinical Research - Huntington Park /ID# 259044	Huntington Park	California	Recruiting
Scripps Whittier Diabetes Institute /ID# 259215	La Jolla	California	Recruiting
Facey Medical Foundation /ID# 260863	Mission Hills	California	Recruiting
Hoag Memorial Hospital Presbyterian /ID# 260990	Newport Beach	California	Recruiting
Diabetes Associates Medical Group /ID# 256949	Orange	California	Recruiting
Western University of Health Sciences /ID# 262183	Pomona	California	Recruiting
Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825	San Mateo	California	Recruiting
Care Access - Santa Clarita /ID# 262573	Santa Clarita	California	Recruiting
Facey Medical Foundation - Valencia /ID# 262102	Santa Clarita	California	Recruiting
Olive View UCLA Medical Center /ID# 259092	Sylmar	California	Recruiting
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572	Torrance	California	Completed
Diablo Clinical Research /ID# 261329	Walnut Creek	California	Recruiting
San Fernando Valley Health Institute /ID# 257363	West Hills	California	Recruiting
New England Research Associates - Bridgeport /ID# 262184	Bridgeport	Connecticut	Recruiting
Innovative Research of West Florida /ID# 257356	Clearwater	Florida	Recruiting
ALL Medical Research /ID# 256748	Cooper City	Florida	Recruiting
Northeast Research Institute (NERI) /ID# 261841	Fleming Island	Florida	Recruiting
Northeast Research Institute (NERI) /ID# 261846	Fleming Island	Florida	Recruiting
The Center for Diabetes and Endocrine Care /ID# 255721	Fort Lauderdale	Florida	Recruiting
Encore Medical Research LLC /ID# 256758	Hollywood	Florida	Recruiting
East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972	Jacksonville	Florida	Recruiting
The University of Florida Heal /ID# 257361	Jacksonville	Florida	Recruiting
East Coast Research - Jacksonville /ID# 256971	Jacksonville	Florida	Recruiting
Encore Research Group-Jacksonville Center for Clinical Research /ID# 256147	Jacksonville	Florida	Recruiting
Baptist Health Research Institute /ID# 260989	Jacksonville	Florida	Recruiting
South Florida Wellness & Clinic /ID# 256513	Margate	Florida	Recruiting
Med Research of Florida /ID# 257837	Miami	Florida	Recruiting
Ocean Blue Medical Research Center, Inc /ID# 260438	Miami Springs	Florida	Recruiting
Adult Medicine of Lake County - Mount Dora /ID# 257371	Mt. Dora	Florida	Recruiting
Suncoast Clinical Research Pasco County /ID# 257018	New Port Richey	Florida	Recruiting
West Orange Endocrinology /ID# 256139	Ocoee	Florida	Recruiting
Suncoast Clinical Research - Palm Harbor /ID# 256741	Palm Harbor	Florida	Recruiting

+ 99 more sites — see the full list on the official registry below.

On this site

📄 Synthroid (levothyroxine) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06345339 on ClinicalTrials.gov ↗ ← All trials in the USA