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 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: M21-341
• Study Type: interventional
• Target: 2,800
• Locations: 2 countries
• Sites: 139

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

Keywords

Hypothyroidism; Armour Thyroid; Synthetic T4

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response

  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).

  Week 55

• Number of Participants with Adverse Events (AEs)

  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.

  Up to approximately 90 weeks

Secondary Outcomes (3)

• Percentage of Participants who Achieve TSH Response

  Week 55

• Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid

  Up to approximately 29 weeks

• Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period

  Week 55

Study Arms (2)

Group 1

EXPERIMENTAL

Participants will receive Armour Thyroid for up to 81 weeks.

Drug: Armour Thyroid

Group 2

EXPERIMENTAL

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

Drug: Armour Thyroid; Drug: Levothyroxine

Interventions

Armour Thyroid DRUG

Oral Capsule or Tablet

Also known as: AGN-282176

Group 1; Group 2

Levothyroxine DRUG

Oral Capsule

Also known as: Synthetic T4

Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (139)

Central Research Associates /ID# 255719

Birmingham, Alabama, 35205, United States

RECRUITING

UAB Hospital /ID# 262565

Birmingham, Alabama, 35233-1932, United States

RECRUITING

Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552

Bonita, California, 91902-1230, United States

RECRUITING

Facey Medical Foundation - Burbank /ID# 262104

Burbank, California, 91505-4554, United States

RECRUITING

John Muir Medical Center /ID# 257103

Concord, California, 94520, United States

RECRUITING

Diagnamics Inc. /ID# 262680

Encinitas, California, 92024, United States

RECRUITING

Providence - St. Jude Medical Center /ID# 256520

Fullerton, California, 92835, United States

RECRUITING

NorCal Medical Research /ID# 256512

Greenbrae, California, 94904, United States

RECRUITING

Velocity Clinical Research - Huntington Park /ID# 259044

Huntington Park, California, 90255-2951, United States

RECRUITING

Scripps Whittier Diabetes Institute /ID# 259215

La Jolla, California, 92037, United States

RECRUITING

Facey Medical Foundation /ID# 260863

Mission Hills, California, 91345, United States

RECRUITING

Hoag Memorial Hospital Presbyterian /ID# 260990

Newport Beach, California, 92663, United States

RECRUITING

Diabetes Associates Medical Group /ID# 256949

Orange, California, 92866-2862, United States

RECRUITING

Western University of Health Sciences /ID# 262183

Pomona, California, 91766, United States

RECRUITING

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

San Mateo, California, 94404, United States

RECRUITING

Care Access - Santa Clarita /ID# 262573

Santa Clarita, California, 91321, United States

RECRUITING

Facey Medical Foundation - Valencia /ID# 262102

Santa Clarita, California, 91355-4462, United States

RECRUITING

Olive View UCLA Medical Center /ID# 259092

Sylmar, California, 91342-1437, United States

RECRUITING

The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572

Torrance, California, 90502, United States

COMPLETED

Diablo Clinical Research /ID# 261329

Walnut Creek, California, 94598, United States

RECRUITING

San Fernando Valley Health Institute /ID# 257363

West Hills, California, 91304-3837, United States

RECRUITING

New England Research Associates - Bridgeport /ID# 262184

Bridgeport, Connecticut, 06606, United States

RECRUITING

Innovative Research of West Florida /ID# 257356

Clearwater, Florida, 33756-2004, United States

RECRUITING

ALL Medical Research /ID# 256748

Cooper City, Florida, 33024, United States

RECRUITING

Northeast Research Institute (NERI) /ID# 261841

Fleming Island, Florida, 32003, United States

RECRUITING

Northeast Research Institute (NERI) /ID# 261846

Fleming Island, Florida, 32003, United States

RECRUITING

The Center for Diabetes and Endocrine Care /ID# 255721

Fort Lauderdale, Florida, 33312, United States

RECRUITING

Encore Medical Research LLC /ID# 256758

Hollywood, Florida, 33021, United States

RECRUITING

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

Jacksonville, Florida, 32204, United States

RECRUITING

The University of Florida Heal /ID# 257361

Jacksonville, Florida, 32207-4966, United States

RECRUITING

East Coast Research - Jacksonville /ID# 256971

Jacksonville, Florida, 32216, United States

RECRUITING

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

Jacksonville, Florida, 32216, United States

RECRUITING

Baptist Health Research Institute /ID# 260989

Jacksonville, Florida, 32258, United States

RECRUITING

South Florida Wellness & Clinic /ID# 256513

Margate, Florida, 33063, United States

RECRUITING

Med Research of Florida /ID# 257837

Miami, Florida, 33186, United States

RECRUITING

Ocean Blue Medical Research Center, Inc /ID# 260438

Miami Springs, Florida, 33166, United States

RECRUITING

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

Mt. Dora, Florida, 32757, United States

RECRUITING

Suncoast Clinical Research Pasco County /ID# 257018

New Port Richey, Florida, 34652, United States

RECRUITING

West Orange Endocrinology /ID# 256139

Ocoee, Florida, 34761-4547, United States

RECRUITING

Suncoast Clinical Research - Palm Harbor /ID# 256741

Palm Harbor, Florida, 34684, United States

RECRUITING

Comprehensive Medical & Research Center /ID# 261678

Plantation, Florida, 33317-2911, United States

RECRUITING

Northeast Research Institute - St. Augustine /ID# 261857

Saint Augustine, Florida, 32080, United States

RECRUITING

Metabolic Research Inst /ID# 255729

West Palm Beach, Florida, 33401, United States

RECRUITING

Grady Clinical Research Center Grady Memorial Hospital /ID# 258419

Atlanta, Georgia, 30303, United States

RECRUITING

Atlanta Diabetes Associates /ID# 255736

Atlanta, Georgia, 30318, United States

RECRUITING

East Coast Institute for Research - Canton /ID# 256974

Canton, Georgia, 30114, United States

RECRUITING

Centricity Research - Endocrine Consultants Research /ID# 255738

Columbus, Georgia, 31904, United States

RECRUITING

Physicians Research Associates, LLC /ID# 255675

Lawrenceville, Georgia, 30046, United States

RECRUITING

The Jones Center Clinical Research /ID# 256529

Macon, Georgia, 31210, United States

RECRUITING

Endocrine Research Solutions /ID# 256784

Roswell, Georgia, 30076, United States

RECRUITING

Pacific Diabetes & Endocrine Center /ID# 259030

Honolulu, Hawaii, 96813, United States

RECRUITING

Rocky Mountain Clinical Research, LLC /ID# 256753

Idaho Falls, Idaho, 83404-7596, United States

RECRUITING

Northwestern University Feinberg School of Medicine /ID# 260677

Chicago, Illinois, 60611-2927, United States

RECRUITING

West Broadway Clinic /ID# 256756

Council Bluffs, Iowa, 51501-3822, United States

RECRUITING

Iowa Diabetes and Endocrinology Research Center /ID# 256750

West Des Moines, Iowa, 50266, United States

RECRUITING

Cotton O'Neil Diabetes & Endocrinology /ID# 256749

Topeka, Kansas, 66606, United States

RECRUITING

University of Louisville Hospital /ID# 262568

Louisville, Kentucky, 40202, United States

RECRUITING

Robley Rex VA Medical Center /ID# 262569

Louisville, Kentucky, 40206, United States

RECRUITING

L-MARC Research Center /ID# 255733

Louisville, Kentucky, 40213-1014, United States

RECRUITING

Pennington Biomedical Research Center /ID# 262390

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Nola Care Clinical Research /ID# 260145

Metairie, Louisiana, 70006-2930, United States

RECRUITING

Omega Clinical Research /ID# 260162

Metairie, Louisiana, 70006-2930, United States

RECRUITING

Tufts Medical Center /ID# 262974

Boston, Massachusetts, 02111-1552, United States

RECRUITING

Circle Health Diabetes and Endocrine Center /ID# 270461

Dracut, Massachusetts, 01826, United States

RECRUITING

NECCR PrimaCare Research, LLC /ID# 256531

Fall River, Massachusetts, 02721, United States

COMPLETED

Metro Detroit Endocrinology Center /ID# 260862

Dearborn, Michigan, 48126, United States

RECRUITING

Michigan Healthcare Professionals /ID# 260859

Farmington Hills, Michigan, 48334, United States

RECRUITING

Elite Clinical Research Center /ID# 256782

Flint, Michigan, 48532, United States

RECRUITING

Diabetes and Endocrinology Specialists /ID# 259068

Chesterfield, Missouri, 63017, United States

RECRUITING

University of Missouri Hospital /ID# 262562

Columbia, Missouri, 65212, United States

RECRUITING

Jefferson City Medical Group /ID# 257099

Jefferson City, Missouri, 65109, United States

RECRUITING

Mercy Research - Springfield /ID# 262385

Springfield, Missouri, 65804, United States

RECRUITING

St. Louis University /ID# 262375

St Louis, Missouri, 63104, United States

RECRUITING

Washington University-School of Medicine /ID# 262391

St Louis, Missouri, 63110, United States

RECRUITING

Billings Clinic /ID# 258316

Billings, Montana, 59101-0733, United States

RECRUITING

Mercury Street Medical /ID# 259632

Butte, Montana, 59701-1652, United States

RECRUITING

Bryan Health Pine Lake Campus /ID# 259638

Lincoln, Nebraska, 68516, United States

RECRUITING

Methodist Physicians Clinic /ID# 259276

Omaha, Nebraska, 68114, United States

RECRUITING

Palm Research Center /ID# 256131

Las Vegas, Nevada, 89148, United States

RECRUITING

Northern Nevada Endocrinology /ID# 259646

Reno, Nevada, 89511, United States

RECRUITING

Southern New Hampshire Diabetes and Endocrinology /ID# 257841

Nashua, New Hampshire, 03060, United States

RECRUITING

Albany Medical College- Endocrinology Washington Extension /ID# 256794

Albany, New York, 12203, United States

RECRUITING

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

Buffalo, New York, 14203, United States

RECRUITING

NYC Research /ID# 258662

New York, New York, 10001, United States

RECRUITING

Endocrine Assc Long Island PC /ID# 257357

Smithtown, New York, 11787, United States

RECRUITING

Physician's East Endocrinology /ID# 256491

Greenville, North Carolina, 27834, United States

RECRUITING

Carteret Medical Group /ID# 256869

Morehead City, North Carolina, 28557, United States

RECRUITING

Lucas Research /ID# 256127

Morehead City, North Carolina, 28557, United States

RECRUITING

Lucas Research /ID# 257061

Morehead City, North Carolina, 28557, United States

RECRUITING

Accellacare - Salisbury /ID# 257019

Salisbury, North Carolina, 28144-2735, United States

RECRUITING

Accellacare Wilmington /ID# 256744

Wilmington, North Carolina, 28401, United States

RECRUITING

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

Canton, Ohio, 44718, United States

RECRUITING

Cleveland Clinic - Cleveland /ID# 262392

Cleveland, Ohio, 44195, United States

RECRUITING

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

Columbus, Ohio, 43203, United States

RECRUITING

Lynn Institute of Norman /ID# 256785

Norman, Oklahoma, 73072, United States

RECRUITING

Lynn Institute of Oklahoma City /ID# 263141

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064

Feasterville-Trevose, Pennsylvania, 19053, United States

RECRUITING

Thomas Jefferson University Hospital /ID# 256834

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Jefferson Health - Roosevelt Boulevard /ID# 256837

Philadelphia, Pennsylvania, 19114-1025, United States

RECRUITING

Guthrie Robert Packer Hospital /ID# 261838

Sayre, Pennsylvania, 18840, United States

RECRUITING

TMA Headlands LLC /ID# 259800

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Carolina Endocrine Associates Llc /ID# 259640

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

RECRUITING

Palmetto Clinical Research - Summerville /ID# 258845

Summerville, South Carolina, 29485, United States

RECRUITING

Chattanooga Medical Research /ID# 257631

Chattanooga, Tennessee, 37404-3239, United States

RECRUITING

PMG Research of Knoxville /ID# 256854

Knoxville, Tennessee, 37938, United States

RECRUITING

University of Tennessee Health Science Center /ID# 259825

Memphis, Tennessee, 38103, United States

RECRUITING

Lifedoc Research /ID# 262975

Memphis, Tennessee, 38115, United States

RECRUITING

Mid State Endocrine Associates /ID# 259641

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Diabetes and Endocrinology - Central Austin /ID# 255728

Austin, Texas, 78731, United States

RECRUITING

Texas Diabetes and Endocrinology - South Austin /ID# 255723

Austin, Texas, 78749, United States

RECRUITING

Brusco, Corpus Christi, TX /ID# 256746

Corpus Christi, Texas, 78414, United States

RECRUITING

North TX Endocrine Center /ID# 255737

Dallas, Texas, 75231, United States

RECRUITING

Research Institute Dallas /ID# 256126

Dallas, Texas, 75231, United States

COMPLETED

Academy of Diabetes, Thyroid and Endocrine /ID# 255735

El Paso, Texas, 79935, United States

RECRUITING

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

Fort Worth, Texas, 76132, United States

RECRUITING

Juno Research /ID# 259238

Houston, Texas, 77040, United States

RECRUITING

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

Houston, Texas, 77043, United States

RECRUITING

PlanIt Research, PLLC /ID# 259221

Houston, Texas, 77079-2204, United States

RECRUITING

Endocrine and Psychiatry Cente /ID# 259631

Houston, Texas, 77095, United States

RECRUITING

Tekton Research - Irving /ID# 260988

Irving, Texas, 75039, United States

RECRUITING

Southern Endocrinology Associates /ID# 256795

Mesquite, Texas, 75149, United States

RECRUITING

Texas Diabetes and Endocrinology /ID# 255722

Round Rock, Texas, 78681, United States

RECRUITING

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

San Antonio, Texas, 78233, United States

RECRUITING

Diabetes & Glandular Disease Clinic /ID# 255734

San Antonio, Texas, 78237, United States

RECRUITING

Consano Clinical Research, LLC /ID# 256138

Shavano Park, Texas, 78231, United States

RECRUITING

Texas Valley Clinical Research /ID# 261476

Weslaco, Texas, 78596, United States

RECRUITING

Advanced Research Institute /ID# 259821

Ogden, Utah, 84405-6779, United States

RECRUITING

The University of Vermont Medical Center /ID# 256533

South Burlington, Vermont, 05403, United States

RECRUITING

Virginia Endocrinology Research /ID# 259623

Chesapeake, Virginia, 23321, United States

RECRUITING

Richmond VA Medical Center /ID# 262386

Richmond, Virginia, 23249, United States

RECRUITING

Salem VA Medical Center /ID# 262387

Salem, Virginia, 24153, United States

RECRUITING

Rainier Clinical Research /ID# 255802

Renton, Washington, 98055, United States

RECRUITING

MultiCare Rockwood Clinic /ID# 255951

Spokane, Washington, 99202, United States

RECRUITING

MultiCare Institute for Research & Innovation /ID# 255954

Tacoma, Washington, 98405, United States

COMPLETED

Clinical Research Investigator Group, LLC /ID# 263177

Bayamón, 00960, Puerto Rico

RECRUITING

ISIS Clinical Research Center /ID# 263182

Guaynabo, 00969-2806, Puerto Rico

RECRUITING

BRCR Global Puerto Rico /ID# 268231

San Juan, 00907-1510, Puerto Rico

RECRUITING

GCM Medical Group, PSC /ID# 263183

San Juan, 00917, Puerto Rico

RECRUITING

Mindful Medical Research /ID# 263184

San Juan, 00918-3756, Puerto Rico

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Hypothyroidism; Thyroid Diseases

Interventions

Thyroid (USP); Thyroxine

Condition Hierarchy (Ancestors)

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

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: April 26, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (134); PR (5)