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 (129)
BRCR Global Puerto Rico /ID# 268231
π΅π·San Juan, Puerto Rico
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572
πΊπΈTorrance, California, United States
Central Research Associates /ID# 255719
πΊπΈBirmingham, Alabama, United States
UAB Hospital /ID# 262565
πΊπΈBirmingham, Alabama, United States
Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552
πΊπΈBonita, California, United States
Facey Medical Foundation - Burbank /ID# 262104
πΊπΈBurbank, California, United States
John Muir Medical Center /ID# 257103
πΊπΈConcord, California, United States
Diagnamics Inc. /ID# 262680
πΊπΈEncinitas, California, United States
Providence - St. Jude Medical Center /ID# 256520
πΊπΈFullerton, California, United States
NorCal Medical Research /ID# 256512
πΊπΈGreenbrae, California, United States
Velocity Clinical Research - Huntington Park /ID# 259044
πΊπΈHuntington Park, California, United States
Scripps Whittier Diabetes Institute /ID# 259215
πΊπΈLa Jolla, California, United States
Facey Medical Foundation /ID# 260863
πΊπΈMission Hills, California, United States
Hoag Memorial Hospital Presbyterian /ID# 260990
πΊπΈNewport Beach, California, United States
Diabetes Associates Medical Group /ID# 256949
πΊπΈOrange, California, United States
Western University of Health Sciences /ID# 262183
πΊπΈPomona, California, United States
Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825
πΊπΈSan Mateo, California, United States
Care Access - Santa Clarita /ID# 262573
πΊπΈSanta Clarita, California, United States
Facey Medical Foundation - Valencia /ID# 262102
πΊπΈSanta Clarita, California, United States
Diablo Clinical Research /ID# 261329
πΊπΈWalnut Creek, California, United States
San Fernando Valley Health Institute /ID# 257363
πΊπΈWest Hills, California, United States
New England Research Associates - Bridgeport /ID# 262184
πΊπΈBridgeport, Connecticut, United States
Innovative Research of West Florida /ID# 257356
πΊπΈClearwater, Florida, United States
ALL Medical Research /ID# 256748
πΊπΈCooper City, Florida, United States
Northeast Research Institute (NERI) /ID# 261841
πΊπΈFleming Island, Florida, United States
Northeast Research Institute (NERI) /ID# 261846
πΊπΈFleming Island, Florida, United States
The Center for Diabetes and Endocrine Care /ID# 255721
πΊπΈFort Lauderdale, Florida, United States
Encore Medical Research LLC /ID# 256758
πΊπΈHollywood, Florida, United States
East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972
πΊπΈJacksonville, Florida, United States
The University of Florida Heal /ID# 257361
πΊπΈJacksonville, Florida, United States
East Coast Research - Jacksonville /ID# 256971
πΊπΈJacksonville, Florida, United States
Encore Research Group-Jacksonville Center for Clinical Research /ID# 256147
πΊπΈJacksonville, Florida, United States
Baptist Health Research Institute /ID# 260989
πΊπΈJacksonville, Florida, United States
South Florida Wellness & Clinic /ID# 256513
πΊπΈMargate, Florida, United States
Ocean Blue Medical Research Center, Inc /ID# 260438
πΊπΈMiami Springs, Florida, United States
Med Research of Florida /ID# 257837
πΊπΈMiami, Florida, United States
Adult Medicine of Lake County - Mount Dora /ID# 257371
πΊπΈMount Dora, Florida, United States
Suncoast Clinical Research Pasco County /ID# 257018
πΊπΈNew Port Richey, Florida, United States
West Orange Endocrinology /ID# 256139
πΊπΈOcoee, Florida, United States
Suncoast Clinical Research - Palm Harbor /ID# 256741
πΊπΈPalm Harbor, Florida, United States
Comprehensive Medical & Research Center /ID# 261678
πΊπΈPlantation, Florida, United States
Northeast Research Institute - St. Augustine /ID# 261857
πΊπΈSaint Augustine, Florida, United States
Metabolic Research Inst /ID# 255729
πΊπΈWest Palm Beach, Florida, United States
Grady Clinical Research Center Grady Memorial Hospital /ID# 258419
πΊπΈAtlanta, Georgia, United States
Atlanta Diabetes Associates /ID# 255736
πΊπΈAtlanta, Georgia, United States
East Coast Institute for Research - Canton /ID# 256974
πΊπΈCanton, Georgia, United States
Columbus Regional Research Ins /ID# 255738
πΊπΈColumbus, Georgia, United States
Physicians Research Associates, LLC /ID# 255675
πΊπΈLawrenceville, Georgia, United States
East Coast Institute for Research - Macon /ID# 256529
πΊπΈMacon, Georgia, United States
Endocrine Research Solutions /ID# 256784
πΊπΈRoswell, Georgia, United States
Pacific Diabetes & Endocrine Center /ID# 259030
πΊπΈHonolulu, Hawaii, United States
Rocky Mountain Clinical Research, LLC /ID# 256753
πΊπΈIdaho Falls, Idaho, United States
Northwestern University Feinberg School of Medicine /ID# 260677
πΊπΈChicago, Illinois, United States
West Broadway Clinic /ID# 256756
πΊπΈCouncil Bluffs, Iowa, United States
Iowa Diabetes and Endocrinology Research Center /ID# 256750
πΊπΈWest Des Moines, Iowa, United States
Cotton O'Neil Digestive Health Center /ID# 256749
πΊπΈTopeka, Kansas, United States
L-MARC Research Center /ID# 255733
πΊπΈLouisville, Kentucky, United States
Pennington Biomedical Research Center /ID# 262390
πΊπΈBaton Rouge, Louisiana, United States
Nola Care Clinical Research /ID# 260145
πΊπΈMetairie, Louisiana, United States
Omega Clinical Research /ID# 260162
πΊπΈMetairie, Louisiana, United States
NECCR PrimaCare Research, LLC /ID# 256531
πΊπΈFall River, Massachusetts, United States
Metro Detroit Endocrinology Center /ID# 260862
πΊπΈDearborn, Michigan, United States
Michigan Healthcare Professionals /ID# 260859
πΊπΈFarmington Hills, Michigan, United States
Elite Clinical Research Center /ID# 256782
πΊπΈFlint, Michigan, United States
Diabetes and Endocrinology Specialists /ID# 259068
πΊπΈChesterfield, Missouri, United States
University of Missouri Hospital /ID# 262562
πΊπΈColumbia, Missouri, United States
Jefferson City Medical Group /ID# 257099
πΊπΈJefferson City, Missouri, United States
Washington University-School of Medicine /ID# 262391
πΊπΈSaint Louis, Missouri, United States
Mercy Research - Springfield /ID# 262385
πΊπΈSpringfield, Missouri, United States
Billings Clinic /ID# 258316
πΊπΈBillings, Montana, United States
Mercury Street Medical /ID# 259632
πΊπΈButte, Montana, United States
Bryan Health Pine Lake Campus /ID# 259638
πΊπΈLincoln, Nebraska, United States
Methodist Physicians Clinic /ID# 259276
πΊπΈOmaha, Nebraska, United States
Palm Research Center /ID# 256131
πΊπΈLas Vegas, Nevada, United States
Northern Nevada Endocrinology /ID# 259646
πΊπΈReno, Nevada, United States
Southern New Hampshire Diabetes and Endocrinology /ID# 257841
πΊπΈNashua, New Hampshire, United States
Albany Medical College- Endocrinology Washington Extension /ID# 256794
πΊπΈAlbany, New York, United States
Research Foundation of SUNY - University of Buffalo /ID# 261019
πΊπΈBuffalo, New York, United States
NYC Research /ID# 258662
πΊπΈNew York, New York, United States
Endocrine Assc Long Island PC /ID# 257357
πΊπΈSmithtown, New York, United States
Physician's East Endocrinology /ID# 256491
πΊπΈGreenville, North Carolina, United States
Carteret Medical Group /ID# 256869
πΊπΈMorehead City, North Carolina, United States
Lucas Research /ID# 256127
πΊπΈMorehead City, North Carolina, United States
Lucas Research /ID# 257061
πΊπΈMorehead City, North Carolina, United States
Accellacare - Salisbury /ID# 257019
πΊπΈSalisbury, North Carolina, United States
Accellacare Wilmington /ID# 256744
πΊπΈWilmington, North Carolina, United States
Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751
πΊπΈCanton, Ohio, United States
Cleveland Clinic - Cleveland /ID# 262392
πΊπΈCleveland, Ohio, United States
Lynn Institute of Norman /ID# 256785
πΊπΈNorman, Oklahoma, United States
Lynn Institute of Oklahoma City /ID# 263141
πΊπΈOklahoma City, Oklahoma, United States
Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064
πΊπΈFeasterville-Trevose, Pennsylvania, United States
Thomas Jefferson University Hospital /ID# 256834
πΊπΈPhiladelphia, Pennsylvania, United States
Jefferson Health - Roosevelt Boulevard /ID# 256837
πΊπΈPhiladelphia, Pennsylvania, United States
Guthrie Robert Packer Hospital /ID# 261838
πΊπΈSayre, Pennsylvania, United States
Trial Management Associates - Myrtle Beach /ID# 259800
πΊπΈMyrtle Beach, South Carolina, United States
Carolina Endocrine Associates Llc /ID# 259640
πΊπΈNorth Charleston, South Carolina, United States
Palmetto Clinical Research - Summerville /ID# 258845
πΊπΈSummerville, South Carolina, United States
Chattanooga Medical Research /ID# 257631
πΊπΈChattanooga, Tennessee, United States
PMG Research of Knoxville /ID# 256854
πΊπΈKnoxville, Tennessee, United States
University of Tennessee Health Science Center /ID# 259825
πΊπΈMemphis, Tennessee, United States
Mid State Endocrine Associates /ID# 259641
πΊπΈNashville, Tennessee, United States
Texas Diabetes and Endocrinology - Central Austin /ID# 255728
πΊπΈAustin, Texas, United States
Texas Diabetes and Endocrinology - South Austin /ID# 255723
πΊπΈAustin, Texas, United States
Brusco, Corpus Christi, TX /ID# 256746
πΊπΈCorpus Christi, Texas, United States
North TX Endocrine Center /ID# 255737
πΊπΈDallas, Texas, United States
Research Institute Dallas /ID# 256126
πΊπΈDallas, Texas, United States
Academy of Diabetes, Thyroid and Endocrine /ID# 255735
πΊπΈEl Paso, Texas, United States
Diabetes and Thyroid Center of Ft. Worth /ID# 256781
πΊπΈFort Worth, Texas, United States
Juno Research /ID# 259238
πΊπΈHouston, Texas, United States
Biopharma Informatic - Houston - Business Center Drive /ID# 256149
πΊπΈHouston, Texas, United States
PlanIt Research, PLLC /ID# 259221
πΊπΈHouston, Texas, United States
Endocrine and Psychiatry Cente /ID# 259631
πΊπΈHouston, Texas, United States
Tekton Research /ID# 260988
πΊπΈIrving, Texas, United States
Southern Endocrinology Associates /ID# 256795
πΊπΈMesquite, Texas, United States
Texas Diabetes and Endocrinology /ID# 255722
πΊπΈRound Rock, Texas, United States
Northeast Clinical Research of San Antonio, LLC /ID# 256868
πΊπΈSan Antonio, Texas, United States
Diabetes & Glandular Disease Clinic /ID# 255734
πΊπΈSan Antonio, Texas, United States
Consano Clinical Research, LLC /ID# 256138
πΊπΈShavano Park, Texas, United States
Texas Valley Clinical Research /ID# 261476
πΊπΈWeslaco, Texas, United States
Advanced Research Institute /ID# 259821
πΊπΈOgden, Utah, United States
Virginia Endocrinology Research /ID# 259623
πΊπΈChesapeake, Virginia, United States
ISIS Clinical Research Center /ID# 263182
π΅π·Guaynabo, Puerto Rico
Salem VA Medical Center /ID# 262387
πΊπΈSalem, Virginia, United States
Rainier Clinical Research /ID# 255802
πΊπΈRenton, Washington, United States
MultiCare Rockwood Clinic /ID# 255951
πΊπΈSpokane, Washington, United States
MultiCare Institute for Research & Innovation /ID# 255954
πΊπΈTacoma, Washington, United States
Clinical Research Investigator Group, LLC /ID# 263177
π΅π·Bayamon, Puerto Rico
GCM Medical Group, PSC /ID# 263183
π΅π·San Juan, Puerto Rico
Mindful Medical Research /ID# 263184
π΅π·San Juan, Puerto Rico