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

December 31, 2025 updated by: AbbVie

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

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.

Study Overview

Status

Recruiting

Conditions

Hypothyroidism

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2800

Phase

Phase 2
Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: ABBVIE CALL CENTER
Phone Number: 844-663-3742
Email: abbvieclinicaltrials@abbvie.com

Study Locations

Puerto Rico
- - Bayamón, Puerto Rico, 00960
    - Recruiting
    - Clinical Research Investigator Group, LLC /ID# 263177
  - Guaynabo, Puerto Rico, 00969-2806
    - Recruiting
    - ISIS Clinical Research Center /ID# 263182
  - San Juan, Puerto Rico, 00917
    - Recruiting
    - GCM Medical Group, PSC /ID# 263183
    - Contact:
      
      Site Coordinator
      
      Phone Number: 787-936-2100
  - San Juan, Puerto Rico, 00907-1510
    - Recruiting
    - BRCR Global Puerto Rico /ID# 268231
  - San Juan, Puerto Rico, 00918-3756
    - Recruiting
    - Mindful Medical Research /ID# 263184
United States
- Alabama
  - Birmingham, Alabama, United States, 35205
    - Recruiting
    - Central Research Associates /ID# 255719
    - Contact:
      
      Site Coordinator
      
      Phone Number: 205-327-1090
  - Birmingham, Alabama, United States, 35233-1932
    - Recruiting
    - UAB Hospital /ID# 262565
- California
  - Bonita, California, United States, 91902-1230
    - Recruiting
    - Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552
  - Burbank, California, United States, 91505-4554
    - Recruiting
    - Facey Medical Foundation - Burbank /ID# 262104
  - Concord, California, United States, 94520
    - Recruiting
    - John Muir Medical Center /ID# 257103
    - Contact:
      
      Site Coordinator
      
      Phone Number: 925-687-8860
  - Encinitas, California, United States, 92024
    - Recruiting
    - Diagnamics Inc. /ID# 262680
  - Fullerton, California, United States, 92835
    - Recruiting
    - Providence - St. Jude Medical Center /ID# 256520
  - Greenbrae, California, United States, 94904
    - Recruiting
    - NorCal Medical Research /ID# 256512
  - Huntington Park, California, United States, 90255-2951
    - Recruiting
    - Velocity Clinical Research - Huntington Park /ID# 259044
  - La Jolla, California, United States, 92037
    - Recruiting
    - Scripps Whittier Diabetes Institute /ID# 259215
  - Mission Hills, California, United States, 91345
    - Recruiting
    - Facey Medical Foundation /ID# 260863
  - Newport Beach, California, United States, 92663
    - Recruiting
    - Hoag Memorial Hospital Presbyterian /ID# 260990
  - Orange, California, United States, 92866-2862
    - Recruiting
    - Diabetes Associates Medical Group /ID# 256949
  - Pomona, California, United States, 91766
    - Recruiting
    - Western University of Health Sciences /ID# 262183
  - San Mateo, California, United States, 94404
    - Recruiting
    - Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825
  - Santa Clarita, California, United States, 91321
    - Recruiting
    - Care Access - Santa Clarita /ID# 262573
  - Santa Clarita, California, United States, 91355-4462
    - Recruiting
    - Facey Medical Foundation - Valencia /ID# 262102
  - Sylmar, California, United States, 91342-1437
    - Recruiting
    - Olive View UCLA Medical Center /ID# 259092
  - Torrance, California, United States, 90502
    - Completed
    - The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572
  - Walnut Creek, California, United States, 94598
    - Recruiting
    - Diablo Clinical Research /ID# 261329
  - West Hills, California, United States, 91304-3837
    - Recruiting
    - San Fernando Valley Health Institute /ID# 257363
- Connecticut
  - Bridgeport, Connecticut, United States, 06606
    - Recruiting
    - New England Research Associates - Bridgeport /ID# 262184
- Florida
  - Clearwater, Florida, United States, 33756-2004
    - Recruiting
    - Innovative Research of West Florida /ID# 257356
    - Contact:
      
      Site Coordinator
      
      Phone Number: (727) 584-6368
  - Cooper City, Florida, United States, 33024
    - Recruiting
    - ALL Medical Research /ID# 256748
  - Fleming Island, Florida, United States, 32003
    - Recruiting
    - Northeast Research Institute (NERI) /ID# 261846
    - Contact:
      
      Site Coordinator
      
      Phone Number: 904-541-8225
  - Fleming Island, Florida, United States, 32003
    - Recruiting
    - Northeast Research Institute (NERI) /ID# 261841
    - Contact:
      
      Site Coordinator
      
      Phone Number: (904) 541-8225
  - Fort Lauderdale, Florida, United States, 33312
    - Recruiting
    - The Center for Diabetes and Endocrine Care /ID# 255721
    - Contact:
      
      Site Coordinator
      
      Phone Number: (954) 963-7191
  - Hollywood, Florida, United States, 33021
    - Recruiting
    - Encore Medical Research LLC /ID# 256758
  - Jacksonville, Florida, United States, 32204
    - Recruiting
    - East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972
  - Jacksonville, Florida, United States, 32207-4966
    - Recruiting
    - The University of Florida Heal /ID# 257361
  - Jacksonville, Florida, United States, 32216
    - Recruiting
    - Encore Research Group-Jacksonville Center for Clinical Research /ID# 256147
  - Jacksonville, Florida, United States, 32216
    - Recruiting
    - East Coast Research - Jacksonville /ID# 256971
    - Contact:
      
      Site Coordinator
      
      Phone Number: (904) 740-4107
  - Jacksonville, Florida, United States, 32258
    - Recruiting
    - Baptist Health Research Institute /ID# 260989
  - Margate, Florida, United States, 33063
    - Recruiting
    - South Florida Wellness & Clinic /ID# 256513
  - Miami, Florida, United States, 33186
    - Recruiting
    - Med Research of Florida /ID# 257837
  - Miami Springs, Florida, United States, 33166
    - Recruiting
    - Ocean Blue Medical Research Center, Inc /ID# 260438
    - Contact:
      
      Site Coordinator
      
      Phone Number: 305-885-8983
  - Mt. Dora, Florida, United States, 32757
    - Recruiting
    - Adult Medicine of Lake County - Mount Dora /ID# 257371
    - Contact:
      
      Site Coordinator
      
      Phone Number: 352-374-0022
  - New Port Richey, Florida, United States, 34652
    - Recruiting
    - Suncoast Clinical Research Pasco County /ID# 257018
    - Contact:
      
      Site Coordinator
      
      Phone Number: 727-849-4131
  - Ocoee, Florida, United States, 34761-4547
    - Recruiting
    - West Orange Endocrinology /ID# 256139
  - Palm Harbor, Florida, United States, 34684
    - Recruiting
    - Suncoast Clinical Research - Palm Harbor /ID# 256741
    - Contact:
      
      Site Coordinator
      
      Phone Number: 727-849-4131
  - Plantation, Florida, United States, 33317-2911
    - Recruiting
    - Comprehensive Medical & Research Center /ID# 261678
  - Saint Augustine, Florida, United States, 32080
    - Recruiting
    - Northeast Research Institute - St. Augustine /ID# 261857
    - Contact:
      
      Site Coordinator
      
      Phone Number: 904-541-8225
  - West Palm Beach, Florida, United States, 33401
    - Recruiting
    - Metabolic Research Inst /ID# 255729
    - Contact:
      
      Site Coordinator
      
      Phone Number: 561-802-3060
- Georgia
  - Atlanta, Georgia, United States, 30318
    - Recruiting
    - Atlanta Diabetes Associates /ID# 255736
  - Atlanta, Georgia, United States, 30303
    - Recruiting
    - Grady Clinical Research Center Grady Memorial Hospital /ID# 258419
  - Canton, Georgia, United States, 30114
    - Recruiting
    - East Coast Institute for Research - Canton /ID# 256974
  - Columbus, Georgia, United States, 31904
    - Recruiting
    - Centricity Research - Endocrine Consultants Research /ID# 255738
  - Lawrenceville, Georgia, United States, 30046
    - Recruiting
    - Physicians Research Associates, LLC /ID# 255675
  - Macon, Georgia, United States, 31210
    - Recruiting
    - The Jones Center Clinical Research /ID# 256529
  - Roswell, Georgia, United States, 30076
    - Recruiting
    - Endocrine Research Solutions /ID# 256784
    - Contact:
      
      Site Coordinator
      
      Phone Number: 678-878-4750
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Recruiting
    - Pacific Diabetes & Endocrine Center /ID# 259030
- Idaho
  - Idaho Falls, Idaho, United States, 83404-7596
    - Recruiting
    - Rocky Mountain Clinical Research, LLC /ID# 256753
- Illinois
  - Chicago, Illinois, United States, 60611-2927
    - Recruiting
    - Northwestern University Feinberg School of Medicine /ID# 260677
- Iowa
  - Council Bluffs, Iowa, United States, 51501-3822
    - Recruiting
    - West Broadway Clinic /ID# 256756
  - West Des Moines, Iowa, United States, 50266
    - Recruiting
    - Iowa Diabetes and Endocrinology Research Center /ID# 256750
- Kansas
  - Topeka, Kansas, United States, 66606
    - Recruiting
    - Cotton O'Neil Diabetes & Endocrinology /ID# 256749
- Kentucky
  - Louisville, Kentucky, United States, 40213-1014
    - Recruiting
    - L-MARC Research Center /ID# 255733
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - University of Louisville Hospital /ID# 262568
  - Louisville, Kentucky, United States, 40206
    - Recruiting
    - Robley Rex VA Medical Center /ID# 262569
    - Contact:
      
      Site Coordinator
      
      Phone Number: 502 287 6260
- Louisiana
  - Baton Rouge, Louisiana, United States, 70808
    - Recruiting
    - Pennington Biomedical Research Center /ID# 262390
  - Metairie, Louisiana, United States, 70006-2930
    - Recruiting
    - Nola Care Clinical Research /ID# 260145
  - Metairie, Louisiana, United States, 70006-2930
    - Recruiting
    - Omega Clinical Research /ID# 260162
- Massachusetts
  - Boston, Massachusetts, United States, 02111-1552
    - Recruiting
    - Tufts Medical Center /ID# 262974
  - Dracut, Massachusetts, United States, 01826
    - Recruiting
    - Circle Health Diabetes and Endocrine Center /ID# 270461
  - Fall River, Massachusetts, United States, 02721
    - Completed
    - NECCR PrimaCare Research, LLC /ID# 256531
- Michigan
  - Dearborn, Michigan, United States, 48126
    - Recruiting
    - Metro Detroit Endocrinology Center /ID# 260862
  - Farmington Hills, Michigan, United States, 48334
    - Recruiting
    - Michigan Healthcare Professionals /ID# 260859
  - Flint, Michigan, United States, 48532
    - Recruiting
    - Elite Clinical Research Center /ID# 256782
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - Recruiting
    - Diabetes and Endocrinology Specialists /ID# 259068
  - Columbia, Missouri, United States, 65212
    - Recruiting
    - University of Missouri Hospital /ID# 262562
  - Jefferson City, Missouri, United States, 65109
    - Recruiting
    - Jefferson City Medical Group /ID# 257099
  - Springfield, Missouri, United States, 65804
    - Recruiting
    - Mercy Research - Springfield /ID# 262385
  - St Louis, Missouri, United States, 63104
    - Recruiting
    - St. Louis University /ID# 262375
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University-School of Medicine /ID# 262391
- Montana
  - Billings, Montana, United States, 59101-0733
    - Recruiting
    - Billings Clinic /ID# 258316
  - Butte, Montana, United States, 59701-1652
    - Recruiting
    - Mercury Street Medical /ID# 259632
- Nebraska
  - Lincoln, Nebraska, United States, 68516
    - Recruiting
    - Bryan Health Pine Lake Campus /ID# 259638
    - Contact:
      
      Site Coordinator
      
      Phone Number: 402-481-8128
  - Omaha, Nebraska, United States, 68114
    - Recruiting
    - Methodist Physicians Clinic /ID# 259276
- Nevada
  - Las Vegas, Nevada, United States, 89148
    - Recruiting
    - Palm Research Center /ID# 256131
  - Reno, Nevada, United States, 89511
    - Recruiting
    - Northern Nevada Endocrinology /ID# 259646
- New Hampshire
  - Nashua, New Hampshire, United States, 03060
    - Recruiting
    - Southern New Hampshire Diabetes and Endocrinology /ID# 257841
- New York
  - Albany, New York, United States, 12203
    - Recruiting
    - Albany Medical College- Endocrinology Washington Extension /ID# 256794
  - Buffalo, New York, United States, 14203
    - Recruiting
    - Research Foundation of SUNY - University of Buffalo /ID# 261019
  - New York, New York, United States, 10001
    - Recruiting
    - NYC Research /ID# 258662
  - Smithtown, New York, United States, 11787
    - Recruiting
    - Endocrine Assc Long Island PC /ID# 257357
- North Carolina
  - Greenville, North Carolina, United States, 27834
    - Recruiting
    - Physician's East Endocrinology /ID# 256491
  - Morehead City, North Carolina, United States, 28557
    - Recruiting
    - Lucas Research /ID# 257061
    - Contact:
      
      Site Coordinator
      
      Phone Number: 828-322-7338
  - Morehead City, North Carolina, United States, 28557
    - Recruiting
    - Lucas Research /ID# 256127
  - Morehead City, North Carolina, United States, 28557
    - Recruiting
    - Carteret Medical Group /ID# 256869
    - Contact:
      
      Site Coordinator
      
      Phone Number: 252-499-8658
  - Salisbury, North Carolina, United States, 28144-2735
    - Recruiting
    - Accellacare - Salisbury /ID# 257019
  - Wilmington, North Carolina, United States, 28401
    - Recruiting
    - Accellacare Wilmington /ID# 256744
- Ohio
  - Canton, Ohio, United States, 44718
    - Recruiting
    - Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Cleveland Clinic - Cleveland /ID# 262392
  - Columbus, Ohio, United States, 43203
    - Recruiting
    - The Ohio State University Wexner Medical Center - CarePoint East /ID# 264061
- Oklahoma
  - Norman, Oklahoma, United States, 73072
    - Recruiting
    - Lynn Institute of Norman /ID# 256785
  - Oklahoma City, Oklahoma, United States, 73112
    - Recruiting
    - Lynn Institute of Oklahoma City /ID# 263141
- Pennsylvania
  - Feasterville-Trevose, Pennsylvania, United States, 19053
    - Recruiting
    - Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064
  - Philadelphia, Pennsylvania, United States, 19114-1025
    - Recruiting
    - Jefferson Health - Roosevelt Boulevard /ID# 256837
  - Philadelphia, Pennsylvania, United States, 19107
    - Recruiting
    - Thomas Jefferson University Hospital /ID# 256834
  - Sayre, Pennsylvania, United States, 18840
    - Recruiting
    - Guthrie Robert Packer Hospital /ID# 261838
- South Carolina
  - Myrtle Beach, South Carolina, United States, 29572
    - Recruiting
    - TMA Headlands LLC /ID# 259800
  - North Charleston, South Carolina, United States, 29406-9823
    - Recruiting
    - Carolina Endocrine Associates Llc /ID# 259640
  - Summerville, South Carolina, United States, 29485
    - Recruiting
    - Palmetto Clinical Research - Summerville /ID# 258845
    - Contact:
      
      Site Coordinator
      
      Phone Number: 843-851-7098
- Tennessee
  - Chattanooga, Tennessee, United States, 37404-3239
    - Recruiting
    - Chattanooga Medical Research /ID# 257631
  - Knoxville, Tennessee, United States, 37938
    - Recruiting
    - PMG Research of Knoxville /ID# 256854
    - Contact:
      
      Site Coordinator
      
      Phone Number: (865) 263-6875
  - Memphis, Tennessee, United States, 38103
    - Recruiting
    - University of Tennessee Health Science Center /ID# 259825
  - Memphis, Tennessee, United States, 38115
    - Recruiting
    - Lifedoc Research /ID# 262975
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Mid State Endocrine Associates /ID# 259641
- Texas
  - Austin, Texas, United States, 78731
    - Recruiting
    - Texas Diabetes and Endocrinology - Central Austin /ID# 255728
    - Contact:
      
      Site Coordinator
      
      Phone Number: 512-334-3505
  - Austin, Texas, United States, 78749
    - Recruiting
    - Texas Diabetes and Endocrinology - South Austin /ID# 255723
  - Corpus Christi, Texas, United States, 78414
    - Recruiting
    - Brusco, Corpus Christi, TX /ID# 256746
  - Dallas, Texas, United States, 75231
    - Recruiting
    - North TX Endocrine Center /ID# 255737
  - Dallas, Texas, United States, 75231
    - Completed
    - Research Institute Dallas /ID# 256126
  - El Paso, Texas, United States, 79935
    - Recruiting
    - Academy of Diabetes, Thyroid and Endocrine /ID# 255735
  - Fort Worth, Texas, United States, 76132
    - Recruiting
    - Diabetes and Thyroid Center of Ft. Worth /ID# 256781
  - Houston, Texas, United States, 77043
    - Recruiting
    - Biopharma Informatic - Houston - Business Center Drive /ID# 256149
  - Houston, Texas, United States, 77079-2204
    - Recruiting
    - PlanIt Research, PLLC /ID# 259221
  - Houston, Texas, United States, 77095
    - Recruiting
    - Endocrine and Psychiatry Cente /ID# 259631
  - Houston, Texas, United States, 77040
    - Recruiting
    - Juno Research /ID# 259238
  - Irving, Texas, United States, 75039
    - Recruiting
    - Tekton Research - Irving /ID# 260988
  - Mesquite, Texas, United States, 75149
    - Recruiting
    - Southern Endocrinology Associates /ID# 256795
  - Round Rock, Texas, United States, 78681
    - Recruiting
    - Texas Diabetes and Endocrinology /ID# 255722
    - Contact:
      
      Site Coordinator
      
      Phone Number: 210-614-8612
  - San Antonio, Texas, United States, 78233
    - Recruiting
    - Northeast Clinical Research of San Antonio, LLC /ID# 256868
    - Contact:
      
      Site Coordinator
      
      Phone Number: 210-581-0045
  - San Antonio, Texas, United States, 78237
    - Recruiting
    - Diabetes & Glandular Disease Clinic /ID# 255734
    - Contact:
      
      Site Coordinator
      
      Phone Number: 210-614-8612Ex210
  - Shavano Park, Texas, United States, 78231
    - Recruiting
    - Consano Clinical Research, LLC /ID# 256138
    - Contact:
      
      Site Coordinator
      
      Phone Number: 210.291.3797
  - Weslaco, Texas, United States, 78596
    - Recruiting
    - Texas Valley Clinical Research /ID# 261476
- Utah
  - Ogden, Utah, United States, 84405-6779
    - Recruiting
    - Advanced Research Institute /ID# 259821
    - Contact:
      
      Site Coordinator
      
      Phone Number: (801) 409-2040
- Vermont
  - South Burlington, Vermont, United States, 05403
    - Recruiting
    - The University of Vermont Medical Center /ID# 256533
- Virginia
  - Chesapeake, Virginia, United States, 23321
    - Recruiting
    - Virginia Endocrinology Research /ID# 259623
  - Richmond, Virginia, United States, 23249
    - Recruiting
    - Richmond VA Medical Center /ID# 262386
  - Salem, Virginia, United States, 24153
    - Recruiting
    - Salem VA Medical Center /ID# 262387
    - Contact:
      
      Site Coordinator
      
      Phone Number: 540 982 2463 x 4973
- Washington
  - Renton, Washington, United States, 98055
    - Recruiting
    - Rainier Clinical Research /ID# 255802
    - Contact:
      
      Site Coordinator
      
      Phone Number: 888-478-8343
  - Spokane, Washington, United States, 99202
    - Recruiting
    - MultiCare Rockwood Clinic /ID# 255951
  - Tacoma, Washington, United States, 98405
    - Completed
    - MultiCare Institute for Research & Innovation /ID# 255954

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 Participants will receive Armour Thyroid for up to 81 weeks.	Drug: Armour Thyroid Oral Capsule or Tablet Other Names: AGN-282176
Experimental: Group 2 Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.	Drug: Armour Thyroid Oral Capsule or Tablet Other Names: AGN-282176 Drug: Levothyroxine Oral Capsule Other Names: Synthetic T4

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who Achieve TSH Response Time Frame: Week 55	TSH response is defined as TSH values falling within 0.45 to 4.12 mIU/L. 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 [stricter than the one used in the Primary Outcome Measure]).	Week 55
Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid Time Frame: Up to approximately 29 weeks	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 Time Frame: Week 55	Frequency of dose titrations (0,1,2...) during the DB period among participants who achieved TSH response at the end of the DB period.	Week 55

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M21-341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypothyroidism

University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Not yet recruiting

T4/T3 Therapy in Hypothyroidism

Hypothyroidism Primary

United States
University of Copenhagen

Recruiting

Ayurvedic Diet in Myxedema (AYUS-MYX)

Hypothyroidism Primary

Denmark
Assiut University

Not yet recruiting

Impact of Subclinical Hypothyroidism on Liver Enzymes and Lipid Profile

Subclinical Hypothyroidism

Egypt
Kerman University of Medical Sciences

Completed

Identification of Important Symptoms and Diagnostic Hypothyroidism Patients Using Machine Learning Algorithms

Prediction Hypothyroidism Patients Using Machine Learning Algorithms | Identification of Important Symptoms of Hypothyroidism

Iran, Islamic Republic of
University Hospital Dubrava

Recruiting

The Effect of Dietary Supplements for Pregnant Women on Levothyroxine Absorption

Hypothyroidism Primary

Croatia
VA Office of Research and Development
Central Arkansas Veterans Healthcare System

Completed

Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism

Subclinical Hypothyroidism

United States
University of Colorado, Denver
Charite University, Berlin, Germany

Terminated

Is Levothyroxine Alone Adequate Thyroid Hormone Replacement?

Hypothyroidism | Postsurgical Hypothyroidism

United States
Abbott
Dimension Research

Completed

The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan (PRECIOUS)

Subclinical Hypothyroidism

Pakistan
Emanuel Amier Diekmann

Unknown

Osteopathy and Latent Hypothyroidism

Latent Hypothyroidism
Assaf-Harofeh Medical Center

Completed

The Effect of Levothyroxine on Arterial Stiffness and Lipid Profile in Patients With Subclinical Hypothyroidism

Subclinical Hypothyroidism

Clinical Trials on Armour Thyroid

Walter Reed National Military Medical Center

Unknown

Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment (DTE)

Primary Hypothyroidism.

United States
Allergan

Completed

A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants

Hypothyroidism | Thyroid Disease | Euthyroid | Thyroid Gland | Thyroid Hormones

United States
Assiut University

Not yet recruiting

Study of Thyroid Status in Patients With IBD

Irritable Bowel Disease | Thyroid Disease

Egypt
Makerere University
Department of Surgery

Completed

Drain or no Drain After Thyroid Surgery: a Randomized Clinical Trial at Mulago Hospital

Wound Sepsis | Hospital Admission Duration | Postoperative Hematoma Formation

Uganda
Gloucestershire Hospitals NHS Foundation Trust

Not yet recruiting

RAman For Thyroid cancER (RAFTER)

Thyroid Diseases | Thyroid Cancer

United Kingdom
Baptist Health South Florida

Completed

New Fabric Attenuation Device in Endovascular Interventional Radiology II (PREFER II) (PREFER-II)

Occupational Exposure to Radiation

United States
MUnlu
Sisli Hamidiye Etfal Training and Research Hospital

Completed

Comparison of TOETVA and Conventional Thyroidectomy (TOETVA)

Surgery | Thyroid | Thyroid Nodule

Turkey
Sohag University

Recruiting

Investigate Relationship Between Thyroid Disorders and Acute Coronary Syndrome.

Thyroid Disorders With Acute Coronary Syndrome

Egypt
Luo Dingcun

Not yet recruiting

Clinical Study of Ultrasonic Artificial Intelligence and Fine Needle Aspiration in Qualitative Diagnosis of Thyroid Nodules

Thyroid Nodule
Brigham and Women's Hospital
Harvard School of Public Health (HSPH); Agency for Healthcare Research and...

Active, not recruiting

Mortality Benefit of Ultrasound for Thyroid Nodules Identified With PET Imaging: Non-Inferiority Emulated Target Trial

Thyroid Cancer | Thyroid Nodule (Benign) | Thyroid Nodule (Diagnosis)

United States

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

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

Study Overview

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Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Hypothyroidism

Clinical Trials on Armour Thyroid

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