AzTrials
AzTrials

HypothyroidismPhase 2/3NCT06345339

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 study testing Armour Thyroid and Levothyroxine in people with Hypothyroidism, run by AbbVie at 139 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypothyroidism
What is being tested?
Armour Thyroid and Levothyroxine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,701 participants
Where
139 sitesin 2 countries
Study dates
26 Apr 2024to Jun 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

139 sites in 2 countries.

139 sites in 2 countries

United States134 sites

  • Albany Medical College- Endocrinology Washington Extension /ID# 256794

    Albany, New York, 12203

  • Grady Clinical Research Center Grady Memorial Hospital /ID# 258419

    Atlanta, Georgia, 30303

  • Atlanta Diabetes Associates /ID# 255736

    Atlanta, Georgia, 30318

  • Texas Diabetes and Endocrinology - Central Austin /ID# 255728

    Austin, Texas, 78731

  • Texas Diabetes and Endocrinology - South Austin /ID# 255723

    Austin, Texas, 78749

  • Pennington Biomedical Research Center /ID# 262390

    Baton Rouge, Louisiana, 70808

  • Billings Clinic /ID# 258316

    Billings, Montana, 59101-0733

  • Central Research Associates /ID# 255719

    Birmingham, Alabama, 35205

  • UAB Hospital /ID# 262565

    Birmingham, Alabama, 35233-1932

  • Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552

    Bonita, California, 91902-1230

  • Tufts Medical Center. /ID# 262974

    Boston, Massachusetts, 02111-1552

  • New England Research Associates - Bridgeport /ID# 262184

    Bridgeport, Connecticut, 06606

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

    Buffalo, New York, 14203

  • Facey Medical Foundation - Burbank /ID# 262104

    Burbank, California, 91505-4554

  • Mercury Street Medical /ID# 259632

    Butte, Montana, 59701-1652

  • East Coast Institute for Research - Canton /ID# 256974

    Canton, Georgia, 30114

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

    Canton, Ohio, 44718

  • Chattanooga Medical Research /ID# 257631

    Chattanooga, Tennessee, 37404-3239

  • Virginia Endocrinology Research /ID# 259623

    Chesapeake, Virginia, 23321

  • Diabetes and Endocrinology Specialists /ID# 259068

    Chesterfield, Missouri, 63017

  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 260677

    Chicago, Illinois, 60611

  • Innovative Research of West Florida /ID# 257356

    Clearwater, Florida, 33756-2004

  • Cleveland Clinic - Cleveland /ID# 262392

    Cleveland, Ohio, 44195

  • University of Missouri Hospital /ID# 262562

    Columbia, Missouri, 65212

  • Centricity Research - Endocrine Consultants Research /ID# 255738

    Columbus, Georgia, 31904

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

    Columbus, Ohio, 43203

  • John Muir Medical Center /ID# 257103

    Concord, California, 94520

  • ALL Medical Research /ID# 256748

    Cooper City, Florida, 33024

  • Brusco, Corpus Christi, TX /ID# 256746

    Corpus Christi, Texas, 78414

  • West Broadway Clinic /ID# 256756

    Council Bluffs, Iowa, 51501-3822

  • North TX Endocrine Center /ID# 255737

    Dallas, Texas, 75231

  • Research Institute Dallas /ID# 256126

    Dallas, Texas, 75231

  • Metro Detroit Endocrinology Center /ID# 260862

    Dearborn, Michigan, 48126

  • Circle Health Diabetes and Endocrine Center /ID# 270461

    Dracut, Massachusetts, 01826

  • Academy of Diabetes, Thyroid and Endocrine /ID# 255735

    El Paso, Texas, 79935

  • Diagnamics Inc. /ID# 262680

    Encinitas, California, 92024

  • NECCR PrimaCare Research, LLC /ID# 256531

    Fall River, Massachusetts, 02721

  • Michigan Healthcare Professionals /ID# 260859

    Farmington Hills, Michigan, 48334

  • Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064

    Feasterville-Trevose, Pennsylvania, 19053

  • Northeast Research Institute (NERI) /ID# 261841

    Fleming Island, Florida, 32003

  • Northeast Research Institute (NERI) /ID# 261846

    Fleming Island, Florida, 32003

  • Elite Clinical Research Center /ID# 256782

    Flint, Michigan, 48532

  • The Center for Diabetes and Endocrine Care /ID# 255721

    Fort Lauderdale, Florida, 33312

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

    Fort Worth, Texas, 76132

  • Providence - St. Jude Medical Center /ID# 256520

    Fullerton, California, 92835

  • NorCal Medical Research /ID# 256512

    Greenbrae, California, 94904

  • Physician's East Endocrinology /ID# 256491

    Greenville, North Carolina, 27834

  • Encore Medical Research /ID# 256758

    Hollywood, Florida, 33021

  • Pacific Diabetes & Endocrine Center /ID# 259030

    Honolulu, Hawaii, 96813

  • Juno Research /ID# 259238

    Houston, Texas, 77040

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

    Houston, Texas, 77043

  • PlanIt Research /ID# 259221

    Houston, Texas, 77079-2204

  • Endocrine and Psychiatry Cente /ID# 259631

    Houston, Texas, 77095

  • Velocity Clinical Research - Huntington Park /ID# 259044

    Huntington Park, California, 90255-2951

  • Rocky Mountain Clinical Research, LLC /ID# 256753

    Idaho Falls, Idaho, 83404-7596

  • Tekton Research - Irving /ID# 260988

    Irving, Texas, 75039

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

    Jacksonville, Florida, 32204

  • The University of Florida Heal /ID# 257361

    Jacksonville, Florida, 32207-4966

  • East Coast Research - Jacksonville /ID# 256971

    Jacksonville, Florida, 32216

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

    Jacksonville, Florida, 32216

  • Baptist Health Research Institute /ID# 260989

    Jacksonville, Florida, 32258

  • Jefferson City Medical Group /ID# 257099

    Jefferson City, Missouri, 65109

  • PMG Research of Knoxville - Knoxville /ID# 256854

    Knoxville, Tennessee, 37938

  • Scripps Whittier Diabetes Institute /ID# 259215

    La Jolla, California, 92037

  • Palm Research Center /ID# 256131

    Las Vegas, Nevada, 89148

  • Physicians Research Associates, LLC /ID# 255675

    Lawrenceville, Georgia, 30046

  • Bryan Health Pine Lake Campus /ID# 259638

    Lincoln, Nebraska, 68516

  • University of Louisville Hospital /ID# 262568

    Louisville, Kentucky, 40202

  • Robley Rex VA Medical Center /ID# 262569

    Louisville, Kentucky, 40206

  • The Jones Center Clinical Research /ID# 256529

    Macon, Georgia, 31210

  • South Florida Wellness & Clinic /ID# 256513

    Margate, Florida, 33063

  • University of Tennessee Health Science Center /ID# 259825

    Memphis, Tennessee, 38103

  • Lifedoc Research /ID# 262975

    Memphis, Tennessee, 38115

  • Southern Endocrinology Associates /ID# 256795

    Mesquite, Texas, 75149

  • Nola Care Clinical Research /ID# 260145

    Metairie, Louisiana, 70006-2930

  • Omega Clinical Research /ID# 260162

    Metairie, Louisiana, 70006-2930

  • Med Research of Florida /ID# 257837

    Miami, Florida, 33186

  • Ocean Blue Medical Research Center, Inc /ID# 260438

    Miami Springs, Florida, 33166

  • Facey Medical Foundation /ID# 260863

    Mission Hills, California, 91345

  • Monroe Biomedical Research /ID# 255733

    Monroe, North Carolina, 28112

  • Carteret Medical Group /ID# 256869

    Morehead City, North Carolina, 28557

  • Centricity Research - Morehead city /ID# 256127

    Morehead City, North Carolina, 28557

  • Centricity Research - Morehead city /ID# 257061

    Morehead City, North Carolina, 28557

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

    Mt. Dora, Florida, 32757

  • TMA Headlands LLC /ID# 259800

    Myrtle Beach, South Carolina, 29572

  • Southern New Hampshire Diabetes and Endocrinology /ID# 257841

    Nashua, New Hampshire, 03060

  • Mid State Endocrine Associates /ID# 259641

    Nashville, Tennessee, 37203

  • Suncoast Clinical Research Pasco County /ID# 257018

    New Port Richey, Florida, 34652

  • NYC Research /ID# 258662

    New York, New York, 10001

  • Hoag Memorial Hospital Presbyterian /ID# 260990

    Newport Beach, California, 92663

  • Lynn Institute of Norman /ID# 256785

    Norman, Oklahoma, 73072

  • Carolina Endocrine Associates Llc /ID# 259640

    North Charleston, South Carolina, 29406-9823

  • West Orange Endocrinology /ID# 256139

    Ocoee, Florida, 34761-4547

  • Advanced Research Institute /ID# 259821

    Ogden, Utah, 84405-6779

  • Lynn Institute of Oklahoma City /ID# 263141

    Oklahoma City, Oklahoma, 73112

  • Methodist Physicians Clinic /ID# 259276

    Omaha, Nebraska, 68114

  • Diabetes Associates Medical Group /ID# 256949

    Orange, California, 92866-2862

  • Suncoast Clinical Research - Palm Harbor /ID# 256741

    Palm Harbor, Florida, 34684

  • Thomas Jefferson University Hospital /ID# 256834

    Philadelphia, Pennsylvania, 19107

  • Northeast Endocrine Metabolic Associates /ID# 256837

    Philadelphia, Pennsylvania, 19114

  • Comprehensive Medical & Research Center /ID# 261678

    Plantation, Florida, 33317-2911

  • Western University of Health Sciences /ID# 262183

    Pomona, California, 91766

  • Northern Nevada Endocrinology /ID# 259646

    Reno, Nevada, 89511

  • Rainier Clinical Research /ID# 255802

    Renton, Washington, 98055

  • Richmond VA Medical Center /ID# 262386

    Richmond, Virginia, 23249

  • Endocrine Research Solutions /ID# 256784

    Roswell, Georgia, 30076

  • Texas Diabetes and Endocrinology /ID# 255722

    Round Rock, Texas, 78681

  • Northeast Research Institute - St. Augustine /ID# 261857

    Saint Augustine, Florida, 32080

  • Salem VA Medical Center /ID# 262387

    Salem, Virginia, 24153

  • Accellacare - Salisbury /ID# 257019

    Salisbury, North Carolina, 28144-2735

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

    San Antonio, Texas, 78233

  • Diabetes and Glandular Disease Clinic /ID# 255734

    San Antonio, Texas, 78237

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

    San Mateo, California, 94404

  • Care Access - Santa Clarita /ID# 262573

    Santa Clarita, California, 91321

  • Facey Medical Foundation - Valencia /ID# 262102

    Santa Clarita, California, 91355-4462

  • Guthrie Robert Packer Hospital /ID# 261838

    Sayre, Pennsylvania, 18840

  • Consano Clinical Research, LLC /ID# 256138

    Shavano Park, Texas, 78231

  • Endocrine Assc Long Island PC /ID# 257357

    Smithtown, New York, 11787

  • The University of Vermont Medical Center /ID# 256533

    South Burlington, Vermont, 05403

  • MultiCare Rockwood Clinic /ID# 255951

    Spokane, Washington, 99202

  • Mercy Research - Springfield /ID# 262385

    Springfield, Missouri, 65804

  • St. Louis University /ID# 262375

    St Louis, Missouri, 63104

  • Washington University /ID# 262391

    St Louis, Missouri, 63110

  • Palmetto Clinical Research - Summerville /ID# 258845

    Summerville, South Carolina, 29485

  • Olive View UCLA Medical Center /ID# 259092

    Sylmar, California, 91342-1437

  • MultiCare Institute for Research and Innovation /ID# 255954

    Tacoma, Washington, 98405

  • Cotton O Neil Diabetes and Endocrinology /ID# 256749

    Topeka, Kansas, 66606

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

    Torrance, California, 90502

  • Diablo Clinical Research /ID# 261329

    Walnut Creek, California, 94598

  • Texas Valley Clinical Research /ID# 261476

    Weslaco, Texas, 78596

  • Iowa Diabetes and Endocrinology Research Center /ID# 256750

    West Des Moines, Iowa, 50266

  • San Fernando Valley Health Institute - West Hills /ID# 257363

    West Hills, California, 91307

  • Metabolic Research Inst /ID# 255729

    West Palm Beach, Florida, 33401

  • Accellacare - Tradd Court - Wilmington /ID# 256744

    Wilmington, North Carolina, 28401

Other trials in United States

Puerto Rico5 sites

  • Clinical Research Investigator Group /ID# 263177

    Bayamón, 00960

  • ISIS Clinical Research Center /ID# 263182

    Guaynabo, 00969-2806

  • BRCR Global Puerto Rico /ID# 268231

    San Juan, 00907-1510

  • GCM Medical Group, PSC /ID# 263183

    San Juan, 00917

  • Mindful Medical Research /ID# 263184

    San Juan, 00918-3756

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions
Hypothyroidism
Being tested
Armour Thyroid, Levothyroxine
Keywords
Hypothyroidism, Armour Thyroid, Synthetic T4
Medical subject headings
Hypothyroidism, Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Armour ThyroidDrug

    Also called AGN-282176

    Oral Capsule or Tablet

  • LevothyroxineDrug

    Also called Synthetic T4

    Oral Capsule

Study groups in NCT06345339
Study groupRoleWhat they receive
Group 1ExperimentalParticipants will receive Armour Thyroid for up to 81 weeks.
Receives: Drug: Armour Thyroid
Group 2ExperimentalParticipants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.
Receives: Drug: Armour Thyroid; Drug: Levothyroxine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week 55

  2. 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.

    Measured: Up to approximately 90 weeks

Secondary outcomes (3)

  1. Percentage of Participants who Achieve TSH Response

    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]).

    Measured: Week 55

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

    Number of participants needing altered dose conversion from synthetic T4 to Armour Thyroid.

    Measured: Up to approximately 29 weeks

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

    Frequency of dose titrations (0,1,2...) during the DB period among participants who achieved TSH response at the end of the DB period.

    Measured: Week 55

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study start26 Apr 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
2,701 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06345339
Sponsor's protocol ID
M21-341
Status last verified
Oct 2026
First submitted
27 Mar 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Armour Thyroid and Levothyroxine in people with Hypothyroidism, run by AbbVie at 139 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response (time frame: Week 55). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06345339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in