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
- Registration Number
- NCT06345339
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2800
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Armour Thyroid Participants will receive Armour Thyroid for up to 81 weeks. Group 2 Armour Thyroid Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. Group 2 Levothyroxine Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response 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).
Number of Participants with Adverse Events (AEs) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants who Achieve TSH Response 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 \[stricter than the one used in the Primary Outcome Measure\]).
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 Frequency of dose titrations (0,1,2...) during the DB period among participants who achieved TSH response at the end of the DB period.
Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid Up to approximately 29 weeks Number of participants needing altered dose conversion from synthetic T4 to Armour Thyroid.
Trial Locations
- Locations (137)
St. Louis University /ID# 262375
🇺🇸Saint Louis, Missouri, United States
Diabetes and Endocrinology Specialists /ID# 259068
🇺🇸Chesterfield, Missouri, United States
Omega Clinical Research /ID# 260162
🇺🇸Metairie, Louisiana, United States
Tufts Medical Center /ID# 262974
🇺🇸Boston, Massachusetts, United States
Metro Detroit Endocrinology Center /ID# 260862
🇺🇸Dearborn, Michigan, United States
Michigan Healthcare Professionals /ID# 260859
🇺🇸Farmington Hills, Michigan, United States
Circle Health Diabetes and Endocrine Center /ID# 270461
🇺🇸Dracut, Massachusetts, United States
NECCR PrimaCare Research, LLC /ID# 256531
🇺🇸Fall River, Massachusetts, United States
Washington University-School of Medicine /ID# 262391
🇺🇸Saint Louis, Missouri, United States
Mercy Research - Springfield /ID# 262385
🇺🇸Springfield, Missouri, United States
Elite Clinical Research Center /ID# 256782
🇺🇸Flint, Michigan, United States
University of Missouri Hospital /ID# 262562
🇺🇸Columbia, Missouri, United States
Jefferson City Medical Group /ID# 257099
🇺🇸Jefferson City, Missouri, United States
Southern New Hampshire Diabetes and Endocrinology /ID# 257841
🇺🇸Nashua, New Hampshire, United States
Albany Medical College- Endocrinology Washington Extension /ID# 256794
🇺🇸Albany, New York, United States
Billings Clinic /ID# 258316
🇺🇸Billings, Montana, United States
Methodist Physicians Clinic /ID# 259276
🇺🇸Omaha, Nebraska, United States
Mercury Street Medical /ID# 259632
🇺🇸Butte, Montana, United States
Northern Nevada Endocrinology /ID# 259646
🇺🇸Reno, Nevada, United States
NYC Research /ID# 258662
🇺🇸New York, New York, United States
Research Foundation of SUNY - University of Buffalo /ID# 261019
🇺🇸Buffalo, New York, United States
Palm Research Center /ID# 256131
🇺🇸Las Vegas, Nevada, United States
Endocrine Assc Long Island PC /ID# 257357
🇺🇸Smithtown, New York, United States
Cleveland Clinic - Cleveland /ID# 262392
🇺🇸Cleveland, Ohio, United States
Thomas Jefferson University Hospital /ID# 256834
🇺🇸Philadelphia, Pennsylvania, United States
Physician's East Endocrinology /ID# 256491
🇺🇸Greenville, North Carolina, United States
Lucas Research /ID# 256127
🇺🇸Morehead City, North Carolina, United States
Accellacare - Salisbury /ID# 257019
🇺🇸Salisbury, North Carolina, United States
Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751
🇺🇸Canton, Ohio, United States
Accellacare Wilmington /ID# 256744
🇺🇸Wilmington, North Carolina, United States
Lynn Institute of Norman /ID# 256785
🇺🇸Norman, Oklahoma, United States
Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064
🇺🇸Feasterville-Trevose, Pennsylvania, United States
Lynn Institute of Oklahoma City /ID# 263141
🇺🇸Oklahoma City, Oklahoma, United States
Guthrie Robert Packer Hospital /ID# 261838
🇺🇸Sayre, Pennsylvania, United States
Jefferson Health - Roosevelt Boulevard /ID# 256837
🇺🇸Philadelphia, Pennsylvania, United States
University of Tennessee Health Science Center /ID# 259825
🇺🇸Memphis, Tennessee, United States
Trial Management Associates - Myrtle Beach /ID# 259800
🇺🇸Myrtle Beach, South Carolina, United States
Brusco, Corpus Christi, TX /ID# 256746
🇺🇸Corpus Christi, Texas, United States
Carolina Endocrine Associates Llc /ID# 259640
🇺🇸North Charleston, South Carolina, United States
Chattanooga Medical Research /ID# 257631
🇺🇸Chattanooga, Tennessee, United States
Lifedoc Research /ID# 262975
🇺🇸Memphis, Tennessee, United States
Mid State Endocrine Associates /ID# 259641
🇺🇸Nashville, Tennessee, United States
Texas Diabetes and Endocrinology - South Austin /ID# 255723
🇺🇸Austin, Texas, United States
North TX Endocrine Center /ID# 255737
🇺🇸Dallas, Texas, United States
Research Institute Dallas /ID# 256126
🇺🇸Dallas, Texas, United States
Academy of Diabetes, Thyroid and Endocrine /ID# 255735
🇺🇸El Paso, Texas, United States
Diabetes and Thyroid Center of Ft. Worth /ID# 256781
🇺🇸Fort Worth, Texas, United States
Endocrine and Psychiatry Cente /ID# 259631
🇺🇸Houston, Texas, United States
Tekton Research - Irving /ID# 260988
🇺🇸Irving, Texas, United States
Juno Research /ID# 259238
🇺🇸Houston, Texas, United States
Biopharma Informatic - Houston - Business Center Drive /ID# 256149
🇺🇸Houston, Texas, United States
Southern Endocrinology Associates /ID# 256795
🇺🇸Mesquite, Texas, United States
PlanIt Research, PLLC /ID# 259221
🇺🇸Houston, Texas, United States
MultiCare Institute for Research & Innovation /ID# 255954
🇺🇸Tacoma, Washington, United States
BRCR Global Puerto Rico /ID# 268231
🇵🇷San Juan, Puerto Rico
Texas Valley Clinical Research /ID# 261476
🇺🇸Weslaco, Texas, United States
The University of Vermont Medical Center /ID# 256533
🇺🇸South Burlington, Vermont, United States
Richmond VA Medical Center /ID# 262386
🇺🇸Richmond, Virginia, United States
MultiCare Rockwood Clinic /ID# 255951
🇺🇸Spokane, Washington, United States
Clinical Research Investigator Group, LLC /ID# 263177
🇵🇷Bayamon, Puerto Rico
Virginia Endocrinology Research /ID# 259623
🇺🇸Chesapeake, Virginia, United States
ISIS Clinical Research Center /ID# 263182
🇵🇷Guaynabo, Puerto Rico
Mindful Medical Research /ID# 263184
🇵🇷San Juan, Puerto Rico
Bryan Health Pine Lake Campus /ID# 259638
🇺🇸Lincoln, Nebraska, United States
Carteret Medical Group /ID# 256869
🇺🇸Morehead City, North Carolina, United States
Lucas Research /ID# 257061
🇺🇸Morehead City, North Carolina, United States
Palmetto Clinical Research - Summerville /ID# 258845
🇺🇸Summerville, South Carolina, United States
PMG Research of Knoxville /ID# 256854
🇺🇸Knoxville, Tennessee, United States
Texas Diabetes and Endocrinology - Central Austin /ID# 255728
🇺🇸Austin, Texas, United States
Texas Diabetes and Endocrinology /ID# 255722
🇺🇸Round Rock, Texas, United States
Northeast Clinical Research of San Antonio, LLC /ID# 256868
🇺🇸San Antonio, Texas, United States
Diabetes & Glandular Disease Clinic /ID# 255734
🇺🇸San Antonio, Texas, United States
Consano Clinical Research, LLC /ID# 256138
🇺🇸Shavano Park, Texas, United States
Advanced Research Institute /ID# 259821
🇺🇸Ogden, Utah, United States
Salem VA Medical Center /ID# 262387
🇺🇸Salem, Virginia, United States
Rainier Clinical Research /ID# 255802
🇺🇸Renton, Washington, United States
GCM Medical Group, PSC /ID# 263183
🇵🇷San Juan, Puerto Rico
Central Research Associates /ID# 255719
🇺🇸Birmingham, Alabama, United States
UAB Hospital /ID# 262565
🇺🇸Birmingham, Alabama, United States
Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552
🇺🇸Bonita, California, United States
Facey Medical Foundation - Burbank /ID# 262104
🇺🇸Burbank, California, United States
John Muir Medical Center /ID# 257103
🇺🇸Concord, California, United States
Diagnamics Inc. /ID# 262680
🇺🇸Encinitas, California, United States
Providence - St. Jude Medical Center /ID# 256520
🇺🇸Fullerton, California, United States
NorCal Medical Research /ID# 256512
🇺🇸Greenbrae, California, United States
Velocity Clinical Research - Huntington Park /ID# 259044
🇺🇸Huntington Park, California, United States
Scripps Whittier Diabetes Institute /ID# 259215
🇺🇸La Jolla, California, United States
Facey Medical Foundation /ID# 260863
🇺🇸Mission Hills, California, United States
Hoag Memorial Hospital Presbyterian /ID# 260990
🇺🇸Newport Beach, California, United States
Diabetes Associates Medical Group /ID# 256949
🇺🇸Orange, California, United States
Western University of Health Sciences /ID# 262183
🇺🇸Pomona, California, United States
Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825
🇺🇸San Mateo, California, United States
Care Access - Santa Clarita /ID# 262573
🇺🇸Santa Clarita, California, United States
Facey Medical Foundation - Valencia /ID# 262102
🇺🇸Santa Clarita, California, United States
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572
🇺🇸Torrance, California, United States
Diablo Clinical Research /ID# 261329
🇺🇸Walnut Creek, California, United States
San Fernando Valley Health Institute /ID# 257363
🇺🇸West Hills, California, United States
New England Research Associates - Bridgeport /ID# 262184
🇺🇸Bridgeport, Connecticut, United States
West Orange Endocrinology /ID# 256139
🇺🇸Ocoee, Florida, United States
Innovative Research of West Florida /ID# 257356
🇺🇸Clearwater, Florida, United States
ALL Medical Research /ID# 256748
🇺🇸Cooper City, Florida, United States
Northeast Research Institute (NERI) /ID# 261841
🇺🇸Fleming Island, Florida, United States
Northeast Research Institute (NERI) /ID# 261846
🇺🇸Fleming Island, Florida, United States
The Center for Diabetes and Endocrine Care /ID# 255721
🇺🇸Fort Lauderdale, Florida, United States
Encore Medical Research LLC /ID# 256758
🇺🇸Hollywood, Florida, United States
East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972
🇺🇸Jacksonville, Florida, United States
The University of Florida Heal /ID# 257361
🇺🇸Jacksonville, Florida, United States
East Coast Research - Jacksonville /ID# 256971
🇺🇸Jacksonville, Florida, United States
Encore Research Group-Jacksonville Center for Clinical Research /ID# 256147
🇺🇸Jacksonville, Florida, United States
Baptist Health Research Institute /ID# 260989
🇺🇸Jacksonville, Florida, United States
South Florida Wellness & Clinic /ID# 256513
🇺🇸Margate, Florida, United States
Ocean Blue Medical Research Center, Inc /ID# 260438
🇺🇸Miami Springs, Florida, United States
Med Research of Florida /ID# 257837
🇺🇸Miami, Florida, United States
Adult Medicine of Lake County - Mount Dora /ID# 257371
🇺🇸Mount Dora, Florida, United States
Suncoast Clinical Research Pasco County /ID# 257018
🇺🇸New Port Richey, Florida, United States
Suncoast Clinical Research - Palm Harbor /ID# 256741
🇺🇸Palm Harbor, Florida, United States
Comprehensive Medical & Research Center /ID# 261678
🇺🇸Plantation, Florida, United States
Northeast Research Institute - St. Augustine /ID# 261857
🇺🇸Saint Augustine, Florida, United States
Metabolic Research Inst /ID# 255729
🇺🇸West Palm Beach, Florida, United States
Grady Clinical Research Center Grady Memorial Hospital /ID# 258419
🇺🇸Atlanta, Georgia, United States
Atlanta Diabetes Associates /ID# 255736
🇺🇸Atlanta, Georgia, United States
East Coast Institute for Research - Canton /ID# 256974
🇺🇸Canton, Georgia, United States
Columbus Regional Research Ins /ID# 255738
🇺🇸Columbus, Georgia, United States
Physicians Research Associates, LLC /ID# 255675
🇺🇸Lawrenceville, Georgia, United States
East Coast Institute for Research - Macon /ID# 256529
🇺🇸Macon, Georgia, United States
Endocrine Research Solutions /ID# 256784
🇺🇸Roswell, Georgia, United States
Pacific Diabetes & Endocrine Center /ID# 259030
🇺🇸Honolulu, Hawaii, United States
Rocky Mountain Clinical Research, LLC /ID# 256753
🇺🇸Idaho Falls, Idaho, United States
Northwestern University Feinberg School of Medicine /ID# 260677
🇺🇸Chicago, Illinois, United States
West Broadway Clinic /ID# 256756
🇺🇸Council Bluffs, Iowa, United States
Iowa Diabetes and Endocrinology Research Center /ID# 256750
🇺🇸West Des Moines, Iowa, United States
Cotton O'Neil Diabetes & Endocrinology /ID# 256749
🇺🇸Topeka, Kansas, United States
University of Louisville Hospital /ID# 262568
🇺🇸Louisville, Kentucky, United States
L-MARC Research Center /ID# 255733
🇺🇸Louisville, Kentucky, United States
Pennington Biomedical Research Center /ID# 262390
🇺🇸Baton Rouge, Louisiana, United States
Nola Care Clinical Research /ID# 260145
🇺🇸Metairie, Louisiana, United States
The Ohio State University Wexner Medical Center - CarePoint East /ID# 264061
🇺🇸Columbus, Ohio, United States