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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

RecruitingPhase 2/3

A Phase 2/3 Multicenter, Double Blinded, Randomized, Dose-conversion, Active Control Study Examining the Efficacy and Safety of Armour Thyroid Compared to Synthetic T4 for the Treatment of Adults With Primary Hypothyroidism

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: AbbVie · Participants: 2,800 · Started: Apr 26, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06345339

Locations in the U.S.

AlabamaCentral Research Associates /ID# 255719, Birmingham
UAB Hospital /ID# 262565, Birmingham
CaliforniaKaiser San Diego Dept Endocrinology, SCPMG /ID# 262552, Bonita
Facey Medical Foundation - Burbank /ID# 262104, Burbank
John Muir Medical Center /ID# 257103, Concord
Diagnamics Inc. /ID# 262680, Encinitas
Providence - St. Jude Medical Center /ID# 256520, Fullerton
NorCal Medical Research /ID# 256512, Greenbrae
Velocity Clinical Research - Huntington Park /ID# 259044, Huntington Park
Scripps Whittier Diabetes Institute /ID# 259215, La Jolla
Facey Medical Foundation /ID# 260863, Mission Hills
Hoag Memorial Hospital Presbyterian /ID# 260990, Newport Beach
Diabetes Associates Medical Group /ID# 256949, Orange
Western University of Health Sciences /ID# 262183, Pomona
Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825, San Mateo
Care Access - Santa Clarita /ID# 262573, Santa Clarita
Facey Medical Foundation - Valencia /ID# 262102, Santa Clarita
Olive View UCLA Medical Center /ID# 259092, Sylmar
Diablo Clinical Research /ID# 261329, Walnut Creek
San Fernando Valley Health Institute /ID# 257363, West Hills
ConnecticutNew England Research Associates - Bridgeport /ID# 262184, Bridgeport
FloridaInnovative Research of West Florida /ID# 257356, Clearwater
ALL Medical Research /ID# 256748, Cooper City
Northeast Research Institute (NERI) /ID# 261841, Fleming Island
Northeast Research Institute (NERI) /ID# 261846, Fleming Island
The Center for Diabetes and Endocrine Care /ID# 255721, Fort Lauderdale
Encore Medical Research LLC /ID# 256758, Hollywood
Baptist Health Research Institute /ID# 260989, Jacksonville
East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972, Jacksonville
East Coast Research - Jacksonville /ID# 256971, Jacksonville
Encore Research Group-Jacksonville Center for Clinical Research /ID# 256147, Jacksonville
The University of Florida Heal /ID# 257361, Jacksonville
South Florida Wellness & Clinic /ID# 256513, Margate
Med Research of Florida /ID# 257837, Miami
Ocean Blue Medical Research Center, Inc /ID# 260438, Miami Springs
Adult Medicine of Lake County - Mount Dora /ID# 257371, Mt. Dora
Suncoast Clinical Research Pasco County /ID# 257018, New Port Richey
West Orange Endocrinology /ID# 256139, Ocoee
Suncoast Clinical Research - Palm Harbor /ID# 256741, Palm Harbor
Comprehensive Medical & Research Center /ID# 261678, Plantation
Northeast Research Institute - St. Augustine /ID# 261857, Saint Augustine
Metabolic Research Inst /ID# 255729, West Palm Beach
GeorgiaAtlanta Diabetes Associates /ID# 255736, Atlanta
Grady Clinical Research Center Grady Memorial Hospital /ID# 258419, Atlanta
East Coast Institute for Research - Canton /ID# 256974, Canton
Centricity Research - Endocrine Consultants Research /ID# 255738, Columbus
Physicians Research Associates, LLC /ID# 255675, Lawrenceville
The Jones Center Clinical Research /ID# 256529, Macon
Endocrine Research Solutions /ID# 256784, Roswell
HawaiiPacific Diabetes & Endocrine Center /ID# 259030, Honolulu
IdahoRocky Mountain Clinical Research, LLC /ID# 256753, Idaho Falls
IllinoisNorthwestern University Feinberg School of Medicine /ID# 260677, Chicago
IowaWest Broadway Clinic /ID# 256756, Council Bluffs
Iowa Diabetes and Endocrinology Research Center /ID# 256750, West Des Moines
KansasCotton O'Neil Diabetes & Endocrinology /ID# 256749, Topeka
KentuckyL-MARC Research Center /ID# 255733, Louisville
Robley Rex VA Medical Center /ID# 262569, Louisville
University of Louisville Hospital /ID# 262568, Louisville
LouisianaPennington Biomedical Research Center /ID# 262390, Baton Rouge
Nola Care Clinical Research /ID# 260145, Metairie
Omega Clinical Research /ID# 260162, Metairie
MassachusettsTufts Medical Center /ID# 262974, Boston
Circle Health Diabetes and Endocrine Center /ID# 270461, Dracut
MichiganMetro Detroit Endocrinology Center /ID# 260862, Dearborn
Michigan Healthcare Professionals /ID# 260859, Farmington Hills
Elite Clinical Research Center /ID# 256782, Flint
MissouriDiabetes and Endocrinology Specialists /ID# 259068, Chesterfield
University of Missouri Hospital /ID# 262562, Columbia
Jefferson City Medical Group /ID# 257099, Jefferson City
Mercy Research - Springfield /ID# 262385, Springfield
St. Louis University /ID# 262375, St Louis
Washington University-School of Medicine /ID# 262391, St Louis
MontanaBillings Clinic /ID# 258316, Billings
Mercury Street Medical /ID# 259632, Butte
NebraskaBryan Health Pine Lake Campus /ID# 259638, Lincoln
Methodist Physicians Clinic /ID# 259276, Omaha
NevadaPalm Research Center /ID# 256131, Las Vegas
Northern Nevada Endocrinology /ID# 259646, Reno
New HampshireSouthern New Hampshire Diabetes and Endocrinology /ID# 257841, Nashua
New YorkAlbany Medical College- Endocrinology Washington Extension /ID# 256794, Albany
Research Foundation of SUNY - University of Buffalo /ID# 261019, Buffalo
NYC Research /ID# 258662, New York
Endocrine Assc Long Island PC /ID# 257357, Smithtown
North CarolinaPhysician's East Endocrinology /ID# 256491, Greenville
Carteret Medical Group /ID# 256869, Morehead City
Lucas Research /ID# 256127, Morehead City
Lucas Research /ID# 257061, Morehead City
Accellacare - Salisbury /ID# 257019, Salisbury
Accellacare Wilmington /ID# 256744, Wilmington
OhioDiabetes and Endocrinology Associates of Stark County Inc /ID# 256751, Canton
Cleveland Clinic - Cleveland /ID# 262392, Cleveland
The Ohio State University Wexner Medical Center - CarePoint East /ID# 264061, Columbus
OklahomaLynn Institute of Norman /ID# 256785, Norman
Lynn Institute of Oklahoma City /ID# 263141, Oklahoma City
PennsylvaniaDiabetes & Endocrinology Consultants of Pennsylvania /ID# 259064, Feasterville-Trevose
Jefferson Health - Roosevelt Boulevard /ID# 256837, Philadelphia
Thomas Jefferson University Hospital /ID# 256834, Philadelphia
Guthrie Robert Packer Hospital /ID# 261838, Sayre
South CarolinaTMA Headlands LLC /ID# 259800, Myrtle Beach
Carolina Endocrine Associates Llc /ID# 259640, North Charleston
Palmetto Clinical Research - Summerville /ID# 258845, Summerville
TennesseeChattanooga Medical Research /ID# 257631, Chattanooga
PMG Research of Knoxville /ID# 256854, Knoxville
Lifedoc Research /ID# 262975, Memphis
University of Tennessee Health Science Center /ID# 259825, Memphis
Mid State Endocrine Associates /ID# 259641, Nashville
TexasTexas Diabetes and Endocrinology - Central Austin /ID# 255728, Austin
Texas Diabetes and Endocrinology - South Austin /ID# 255723, Austin
Brusco, Corpus Christi, TX /ID# 256746, Corpus Christi
North TX Endocrine Center /ID# 255737, Dallas
Academy of Diabetes, Thyroid and Endocrine /ID# 255735, El Paso
Diabetes and Thyroid Center of Ft. Worth /ID# 256781, Fort Worth
Biopharma Informatic - Houston - Business Center Drive /ID# 256149, Houston
Endocrine and Psychiatry Cente /ID# 259631, Houston
Juno Research /ID# 259238, Houston
PlanIt Research, PLLC /ID# 259221, Houston
Tekton Research - Irving /ID# 260988, Irving
Southern Endocrinology Associates /ID# 256795, Mesquite
Texas Diabetes and Endocrinology /ID# 255722, Round Rock
Diabetes & Glandular Disease Clinic /ID# 255734, San Antonio
Northeast Clinical Research of San Antonio, LLC /ID# 256868, San Antonio
Consano Clinical Research, LLC /ID# 256138, Shavano Park
Texas Valley Clinical Research /ID# 261476, Weslaco
UtahAdvanced Research Institute /ID# 259821, Ogden
VermontThe University of Vermont Medical Center /ID# 256533, South Burlington
VirginiaVirginia Endocrinology Research /ID# 259623, Chesapeake
Richmond VA Medical Center /ID# 262386, Richmond
Salem VA Medical Center /ID# 262387, Salem
WashingtonRainier Clinical Research /ID# 255802, Renton
MultiCare Rockwood Clinic /ID# 255951, Spokane

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.