Recruiting

Phase 2

Phase 3

Armour Thyroid vs. T4A 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

Code:

NCT06345339

Conditions

Hypothyroidism

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Armour Thyroid

Levothyroxine

Study Details

Brief 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.

Conditions

Hypothyroidism

Study ID

NCT06345339

Start date

Apr 26, 2024

Status verified date

Dec, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

Participants will receive Armour Thyroid for up to 81 weeks.

experimental: Group 2

Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.

Interventions

Armour Thyroid

Oral Capsule or Tablet

Levothyroxine

Oral Capsule

Primary outcome measure

Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response [ Time Frame: Week 55 ]
Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 90 weeks ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

Central Research Associates /ID# 255719

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Site Coordinator

205-327-1090

UAB Hospital /ID# 262565

Recruiting

Birmingham, Alabama, United States, 35233-1932

Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552

Recruiting

Bonita, California, United States, 91902-1230

Facey Medical Foundation - Burbank /ID# 262104

Recruiting

Burbank, California, United States, 91505-4554

John Muir Medical Center /ID# 257103

Recruiting

Concord, California, United States, 94520

Contacts

Site Coordinator

925-687-8860

Diagnamics Inc. /ID# 262680

Recruiting

Encinitas, California, United States, 92024

Providence - St. Jude Medical Center /ID# 256520

Recruiting

Fullerton, California, United States, 92835

NorCal Medical Research /ID# 256512

Recruiting

Greenbrae, California, United States, 94904

Velocity Clinical Research - Huntington Park /ID# 259044

Recruiting

Huntington Park, California, United States, 90255-2951

Scripps Whittier Diabetes Institute /ID# 259215

Recruiting

La Jolla, California, United States, 92037

Facey Medical Foundation /ID# 260863

Recruiting

Mission Hills, California, United States, 91345

Hoag Memorial Hospital Presbyterian /ID# 260990

Recruiting

Newport Beach, California, United States, 92663

Diabetes Associates Medical Group /ID# 256949

Recruiting

Orange, California, United States, 92866-2862

Western University of Health Sciences /ID# 262183

Recruiting

Pomona, California, United States, 91766

Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825

Recruiting

San Mateo, California, United States, 94404

Care Access - Santa Clarita /ID# 262573

Recruiting

Santa Clarita, California, United States, 91321

Facey Medical Foundation - Valencia /ID# 262102

Recruiting

Santa Clarita, California, United States, 91355-4462

Olive View UCLA Medical Center /ID# 259092

Recruiting

Sylmar, California, United States, 91342-1437

Diablo Clinical Research /ID# 261329

Recruiting

Walnut Creek, California, United States, 94598

San Fernando Valley Health Institute /ID# 257363

Recruiting

West Hills, California, United States, 91304-3837

New England Research Associates - Bridgeport /ID# 262184

Recruiting

Bridgeport, Connecticut, United States, 06606

Innovative Research of West Florida /ID# 257356

Recruiting

Clearwater, Florida, United States, 33756-2004

Contacts

Site Coordinator

(727) 584-6368

ALL Medical Research /ID# 256748

Recruiting

Cooper City, Florida, United States, 33024

Northeast Research Institute (NERI) /ID# 261841

Recruiting

Fleming Island, Florida, United States, 32003

Northeast Research Institute (NERI) /ID# 261846

Recruiting

Fleming Island, Florida, United States, 32003

Contacts

Site Coordinator

904-541-8225

The Center for Diabetes and Endocrine Care /ID# 255721

Recruiting

Fort Lauderdale, Florida, United States, 33312

Contacts

Site Coordinator

(954) 963-7191

Encore Medical Research LLC /ID# 256758

Recruiting

Hollywood, Florida, United States, 33021

East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972

Recruiting

Jacksonville, Florida, United States, 32204

The University of Florida Heal /ID# 257361

Recruiting

Jacksonville, Florida, United States, 32207-4966

East Coast Research - Jacksonville /ID# 256971

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Site Coordinator

(904) 740-4107

Encore Research Group-Jacksonville Center for Clinical Research /ID# 256147

Recruiting

Jacksonville, Florida, United States, 32216

Baptist Health Research Institute /ID# 260989

Recruiting

Jacksonville, Florida, United States, 32258

South Florida Wellness & Clinic /ID# 256513

Recruiting

Margate, Florida, United States, 33063

Med Research of Florida /ID# 257837

Recruiting

Miami, Florida, United States, 33186

Ocean Blue Medical Research Center, Inc /ID# 260438

Recruiting

Miami Springs, Florida, United States, 33166

Contacts

Site Coordinator

305-885-8983

Adult Medicine of Lake County - Mount Dora /ID# 257371

Recruiting

Mt. Dora, Florida, United States, 32757

Contacts

Site Coordinator

352-374-0022

Suncoast Clinical Research Pasco County /ID# 257018

Recruiting

New Port Richey, Florida, United States, 34652

Contacts

Site Coordinator

727-849-4131

West Orange Endocrinology /ID# 256139

Recruiting

Ocoee, Florida, United States, 34761-4547

Suncoast Clinical Research - Palm Harbor /ID# 256741

Recruiting

Palm Harbor, Florida, United States, 34684

Contacts

Site Coordinator

727-849-4131

Comprehensive Medical & Research Center /ID# 261678

Recruiting

Plantation, Florida, United States, 33317-2911

Northeast Research Institute - St. Augustine /ID# 261857

Recruiting

Saint Augustine, Florida, United States, 32080

Contacts

Site Coordinator

904-541-8225

Metabolic Research Inst /ID# 255729

Recruiting

West Palm Beach, Florida, United States, 33401

Contacts

Site Coordinator

561-802-3060

Grady Clinical Research Center Grady Memorial Hospital /ID# 258419

Recruiting

Atlanta, Georgia, United States, 30303

Atlanta Diabetes Associates /ID# 255736

Recruiting

Atlanta, Georgia, United States, 30318

East Coast Institute for Research - Canton /ID# 256974

Recruiting

Canton, Georgia, United States, 30114

Centricity Research - Endocrine Consultants Research /ID# 255738

Recruiting

Columbus, Georgia, United States, 31904

Physicians Research Associates, LLC /ID# 255675

Recruiting

Lawrenceville, Georgia, United States, 30046

The Jones Center Clinical Research /ID# 256529

Recruiting

Macon, Georgia, United States, 31210

Endocrine Research Solutions /ID# 256784

Recruiting

Roswell, Georgia, United States, 30076

Contacts

Site Coordinator

678-878-4750

Pacific Diabetes & Endocrine Center /ID# 259030

Recruiting

Honolulu, Hawaii, United States, 96813

Rocky Mountain Clinical Research, LLC /ID# 256753

Recruiting

Idaho Falls, Idaho, United States, 83404-7596

Northwestern University Feinberg School of Medicine /ID# 260677

Recruiting

Chicago, Illinois, United States, 60611-2927

West Broadway Clinic /ID# 256756

Recruiting

Council Bluffs, Iowa, United States, 51501-3822

Iowa Diabetes and Endocrinology Research Center /ID# 256750

Recruiting

West Des Moines, Iowa, United States, 50266

Cotton O'Neil Diabetes & Endocrinology /ID# 256749

Recruiting

Topeka, Kansas, United States, 66606

University of Louisville Hospital /ID# 262568

Recruiting

Louisville, Kentucky, United States, 40202

Robley Rex VA Medical Center /ID# 262569

Recruiting

Louisville, Kentucky, United States, 40206

Contacts

Site Coordinator

502 287 6260

L-MARC Research Center /ID# 255733

Recruiting

Louisville, Kentucky, United States, 40213-1014

Pennington Biomedical Research Center /ID# 262390

Recruiting

Baton Rouge, Louisiana, United States, 70808

Nola Care Clinical Research /ID# 260145

Recruiting

Metairie, Louisiana, United States, 70006-2930

Omega Clinical Research /ID# 260162

Recruiting

Metairie, Louisiana, United States, 70006-2930

Tufts Medical Center /ID# 262974

Recruiting

Boston, Massachusetts, United States, 02111-1552

Circle Health Diabetes and Endocrine Center /ID# 270461

Recruiting

Dracut, Massachusetts, United States, 01826

Metro Detroit Endocrinology Center /ID# 260862

Recruiting

Dearborn, Michigan, United States, 48126

Michigan Healthcare Professionals /ID# 260859

Recruiting

Farmington Hills, Michigan, United States, 48334

Elite Clinical Research Center /ID# 256782

Recruiting

Flint, Michigan, United States, 48532

Diabetes and Endocrinology Specialists /ID# 259068

Recruiting

Chesterfield, Missouri, United States, 63017

University of Missouri Hospital /ID# 262562

Recruiting

Columbia, Missouri, United States, 65212

Jefferson City Medical Group /ID# 257099

Recruiting

Jefferson City, Missouri, United States, 65109

Mercy Research - Springfield /ID# 262385

Recruiting

Springfield, Missouri, United States, 65804

St. Louis University /ID# 262375

Recruiting

St Louis, Missouri, United States, 63104

Washington University-School of Medicine /ID# 262391

Recruiting

St Louis, Missouri, United States, 63110

Billings Clinic /ID# 258316

Recruiting

Billings, Montana, United States, 59101-0733

Mercury Street Medical /ID# 259632

Recruiting

Butte, Montana, United States, 59701-1652

Bryan Health Pine Lake Campus /ID# 259638

Recruiting

Lincoln, Nebraska, United States, 68516

Contacts

Site Coordinator

402-481-8128

Methodist Physicians Clinic /ID# 259276

Recruiting

Omaha, Nebraska, United States, 68114

Palm Research Center /ID# 256131

Recruiting

Las Vegas, Nevada, United States, 89148

Northern Nevada Endocrinology /ID# 259646

Recruiting

Reno, Nevada, United States, 89511

Southern New Hampshire Diabetes and Endocrinology /ID# 257841

Recruiting

Nashua, New Hampshire, United States, 03060

Albany Medical College- Endocrinology Washington Extension /ID# 256794

Recruiting

Albany, New York, United States, 12203

Research Foundation of SUNY - University of Buffalo /ID# 261019

Recruiting

Buffalo, New York, United States, 14203

NYC Research /ID# 258662

Recruiting

New York, New York, United States, 10001

Endocrine Assc Long Island PC /ID# 257357

Recruiting

Smithtown, New York, United States, 11787

Physician's East Endocrinology /ID# 256491

Recruiting

Greenville, North Carolina, United States, 27834

Carteret Medical Group /ID# 256869

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

Site Coordinator

252-499-8658

Lucas Research /ID# 256127

Recruiting

Morehead City, North Carolina, United States, 28557

Lucas Research /ID# 257061

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

Site Coordinator

828-322-7338

Accellacare - Salisbury /ID# 257019

Recruiting

Salisbury, North Carolina, United States, 28144-2735

Accellacare Wilmington /ID# 256744

Recruiting

Wilmington, North Carolina, United States, 28401

Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751

Recruiting

Canton, Ohio, United States, 44718

Cleveland Clinic - Cleveland /ID# 262392

Recruiting

Cleveland, Ohio, United States, 44195

The Ohio State University Wexner Medical Center - CarePoint East /ID# 264061

Recruiting

Columbus, Ohio, United States, 43203

Lynn Institute of Norman /ID# 256785

Recruiting

Norman, Oklahoma, United States, 73072

Lynn Institute of Oklahoma City /ID# 263141

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064

Recruiting

Feasterville-Trevose, Pennsylvania, United States, 19053

Thomas Jefferson University Hospital /ID# 256834

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Jefferson Health - Roosevelt Boulevard /ID# 256837

Recruiting

Philadelphia, Pennsylvania, United States, 19114-1025

Guthrie Robert Packer Hospital /ID# 261838

Recruiting

Sayre, Pennsylvania, United States, 18840

TMA Headlands LLC /ID# 259800

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Carolina Endocrine Associates Llc /ID# 259640

Recruiting

North Charleston, South Carolina, United States, 29406-9823

Palmetto Clinical Research - Summerville /ID# 258845

Recruiting

Summerville, South Carolina, United States, 29485

Contacts

Site Coordinator

843-851-7098

Chattanooga Medical Research /ID# 257631

Recruiting

Chattanooga, Tennessee, United States, 37404-3239

PMG Research of Knoxville /ID# 256854

Recruiting

Knoxville, Tennessee, United States, 37938

Contacts

Site Coordinator

(865) 263-6875

University of Tennessee Health Science Center /ID# 259825

Recruiting

Memphis, Tennessee, United States, 38103

Lifedoc Research /ID# 262975

Recruiting

Memphis, Tennessee, United States, 38115

Mid State Endocrine Associates /ID# 259641

Recruiting

Nashville, Tennessee, United States, 37203

Texas Diabetes and Endocrinology - Central Austin /ID# 255728

Recruiting

Austin, Texas, United States, 78731

Contacts

Site Coordinator

512-334-3505

Texas Diabetes and Endocrinology - South Austin /ID# 255723

Recruiting

Austin, Texas, United States, 78749

Brusco, Corpus Christi, TX /ID# 256746

Recruiting

Corpus Christi, Texas, United States, 78414

North TX Endocrine Center /ID# 255737

Recruiting

Dallas, Texas, United States, 75231

Academy of Diabetes, Thyroid and Endocrine /ID# 255735

Recruiting

El Paso, Texas, United States, 79935

Diabetes and Thyroid Center of Ft. Worth /ID# 256781

Recruiting

Fort Worth, Texas, United States, 76132

Juno Research /ID# 259238

Recruiting

Houston, Texas, United States, 77040

Biopharma Informatic - Houston - Business Center Drive /ID# 256149

Recruiting

Houston, Texas, United States, 77043

PlanIt Research, PLLC /ID# 259221

Recruiting

Houston, Texas, United States, 77079-2204

Endocrine and Psychiatry Cente /ID# 259631

Recruiting

Houston, Texas, United States, 77095

Tekton Research - Irving /ID# 260988

Recruiting

Irving, Texas, United States, 75039

Southern Endocrinology Associates /ID# 256795

Recruiting

Mesquite, Texas, United States, 75149

Texas Diabetes and Endocrinology /ID# 255722

Recruiting

Round Rock, Texas, United States, 78681

Contacts

Site Coordinator

210-614-8612

Northeast Clinical Research of San Antonio, LLC /ID# 256868

Recruiting

San Antonio, Texas, United States, 78233

Contacts

Site Coordinator

210-581-0045

Diabetes & Glandular Disease Clinic /ID# 255734

Recruiting

San Antonio, Texas, United States, 78237

Contacts

Site Coordinator

210-614-8612Ex210

Consano Clinical Research, LLC /ID# 256138

Recruiting

Shavano Park, Texas, United States, 78231

Contacts

Site Coordinator

210.291.3797

Texas Valley Clinical Research /ID# 261476

Recruiting

Weslaco, Texas, United States, 78596

Advanced Research Institute /ID# 259821

Recruiting

Ogden, Utah, United States, 84405-6779

Contacts

Site Coordinator

(801) 409-2040

The University of Vermont Medical Center /ID# 256533

Recruiting

South Burlington, Vermont, United States, 05403

Virginia Endocrinology Research /ID# 259623

Recruiting

Chesapeake, Virginia, United States, 23321

Richmond VA Medical Center /ID# 262386

Recruiting

Richmond, Virginia, United States, 23249

Salem VA Medical Center /ID# 262387

Recruiting

Salem, Virginia, United States, 24153

Contacts

Site Coordinator

540 982 2463 x 4973

Rainier Clinical Research /ID# 255802

Recruiting

Renton, Washington, United States, 98055

Contacts

Site Coordinator

888-478-8343

MultiCare Rockwood Clinic /ID# 255951

Recruiting

Spokane, Washington, United States, 99202

More Information

Sponsor

AbbVie

Last update posted

Jan 5, 2026

Last verified

Dec, 2025

Keywords

Hypothyroidism
Armour Thyroid
Synthetic T4

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-23. This information was provided to ClinicalTrials.gov by AbbVie on 2026-01-05.