Clinical trial NCT06345339: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Hypothyroidism
Keywords: Hypothyroidism
Armour Thyroid
Synthetic T4
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 2800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response
timeFrame: Week 55
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 90 weeks
Secondary outcomes:
measure: Percentage of Participants who Achieve TSH Response
timeFrame: Week 55
measure: Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid
timeFrame: Up to approximately 29 weeks
measure: Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period
timeFrame: Week 55
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates /ID# 255719
state: Alabama
city: Birmingham
country: United States
facility: UAB Hospital /ID# 262565
state: Alabama
city: Bonita
country: United States
facility: Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552
state: California
city: Burbank
country: United States
facility: Facey Medical Foundation - Burbank /ID# 262104
state: California
city: Concord
country: United States
facility: John Muir Medical Center /ID# 257103
state: California
city: Encinitas
country: United States
facility: Diagnamics Inc. /ID# 262680
state: California
city: Fullerton
country: United States
facility: Providence - St. Jude Medical Center /ID# 256520
state: California
city: Greenbrae
country: United States
facility: NorCal Medical Research /ID# 256512
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research - Huntington Park /ID# 259044
state: California
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Institute /ID# 259215
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation /ID# 260863
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian /ID# 260990
state: California
city: Orange
country: United States
facility: Diabetes Associates Medical Group /ID# 256949
state: California
city: Pomona
country: United States
facility: Western University of Health Sciences /ID# 262183
state: California
city: San Mateo
country: United States
facility: Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825
state: California
city: Santa Clarita
country: United States
facility: Care Access - Santa Clarita /ID# 262573
state: California
city: Santa Clarita
country: United States
facility: Facey Medical Foundation - Valencia /ID# 262102
state: California
city: Torrance
country: United States
facility: The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research /ID# 261329
state: California
city: West Hills
country: United States
facility: San Fernando Valley Health Institute /ID# 257363
state: California
city: Bridgeport
country: United States
facility: New England Research Associates - Bridgeport /ID# 262184
state: Connecticut
city: Clearwater
country: United States
facility: Innovative Research of West Florida /ID# 257356
state: Florida
city: Cooper City
country: United States
facility: ALL Medical Research /ID# 256748
state: Florida
city: Fleming Island
country: United States
facility: Northeast Research Institute (NERI) /ID# 261841
state: Florida
city: Fleming Island
country: United States
facility: Northeast Research Institute (NERI) /ID# 261846
state: Florida
city: Fort Lauderdale
country: United States
facility: The Center for Diabetes and Endocrine Care /ID# 255721
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research LLC /ID# 256758
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute For Research - LaVilla - West Monroe Street /ID# 256972
state: Florida
city: Jacksonville
country: United States
facility: The University of Florida Heal /ID# 257361
state: Florida
city: Jacksonville
country: United States
facility: East Coast Research - Jacksonville /ID# 256971
state: Florida
city: Jacksonville
country: United States
facility: Encore Research Group-Jacksonville Center for Clinical Research /ID# 256147
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health Research Institute /ID# 260989
state: Florida
city: Margate
country: United States
facility: South Florida Wellness & Clinic /ID# 256513
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc /ID# 260438
state: Florida
city: Miami
country: United States
facility: Med Research of Florida /ID# 257837
state: Florida
city: Mount Dora
country: United States
facility: Adult Medicine of Lake County - Mount Dora /ID# 257371
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research Pasco County /ID# 257018
state: Florida
city: Ocoee
country: United States
facility: West Orange Endocrinology /ID# 256139
state: Florida
city: Palm Harbor
country: United States
facility: Suncoast Clinical Research - Palm Harbor /ID# 256741
state: Florida
city: Plantation
country: United States
facility: Comprehensive Medical & Research Center /ID# 261678
state: Florida
city: Saint Augustine
country: United States
facility: Northeast Research Institute - St. Augustine /ID# 261857
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Inst /ID# 255729
state: Florida
city: Atlanta
country: United States
facility: Grady Clinical Research Center Grady Memorial Hospital /ID# 258419
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates /ID# 255736
state: Georgia
city: Canton
country: United States
facility: East Coast Institute for Research - Canton /ID# 256974
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Ins /ID# 255738
state: Georgia
city: Lawrenceville
country: United States
facility: Physicians Research Associates, LLC /ID# 255675
state: Georgia
city: Macon
country: United States
facility: East Coast Institute for Research - Macon /ID# 256529
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions /ID# 256784
state: Georgia
city: Honolulu
country: United States
facility: Pacific Diabetes & Endocrine Center /ID# 259030
state: Hawaii
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research, LLC /ID# 256753
state: Idaho
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 260677
state: Illinois
city: Council Bluffs
country: United States
facility: West Broadway Clinic /ID# 256756
state: Iowa
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center /ID# 256750
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes & Endocrinology /ID# 256749
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Hospital /ID# 262568
state: Kentucky
city: Louisville
country: United States
facility: Robley Rex VA Medical Center /ID# 262569
state: Kentucky
city: Louisville
country: United States
facility: L-MARC Research Center /ID# 255733
state: Kentucky
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center /ID# 262390
state: Louisiana
city: Metairie
country: United States
facility: Nola Care Clinical Research /ID# 260145
state: Louisiana
city: Metairie
country: United States
facility: Omega Clinical Research /ID# 260162
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center /ID# 262974
state: Massachusetts
city: Dracut
country: United States
facility: Circle Health Diabetes and Endocrine Center /ID# 270461
state: Massachusetts
city: Fall River
country: United States
facility: NECCR PrimaCare Research, LLC /ID# 256531
state: Massachusetts
city: Dearborn
country: United States
facility: Metro Detroit Endocrinology Center /ID# 260862
state: Michigan
city: Farmington Hills
country: United States
facility: Michigan Healthcare Professionals /ID# 260859
state: Michigan
city: Flint
country: United States
facility: Elite Clinical Research Center /ID# 256782
state: Michigan
city: Chesterfield
country: United States
facility: Diabetes and Endocrinology Specialists /ID# 259068
state: Missouri
city: Columbia
country: United States
facility: University of Missouri Hospital /ID# 262562
state: Missouri
city: Jefferson City
country: United States
facility: Jefferson City Medical Group /ID# 257099
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University /ID# 262375
state: Missouri
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 262391
state: Missouri
city: Springfield
country: United States
facility: Mercy Research - Springfield /ID# 262385
state: Missouri
city: Billings
country: United States
facility: Billings Clinic /ID# 258316
state: Montana
city: Butte
country: United States
facility: Mercury Street Medical /ID# 259632
state: Montana
city: Lincoln
country: United States
facility: Bryan Health Pine Lake Campus /ID# 259638
state: Nebraska
city: Omaha
country: United States
facility: Methodist Physicians Clinic /ID# 259276
state: Nebraska
city: Las Vegas
country: United States
facility: Palm Research Center /ID# 256131
state: Nevada
city: Reno
country: United States
facility: Northern Nevada Endocrinology /ID# 259646
state: Nevada
city: Nashua
country: United States
facility: Southern New Hampshire Diabetes and Endocrinology /ID# 257841
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical College- Endocrinology Washington Extension /ID# 256794
state: New York
city: Buffalo
country: United States
facility: Research Foundation of SUNY - University of Buffalo /ID# 261019
state: New York
city: New York
country: United States
facility: NYC Research /ID# 258662
state: New York
city: Smithtown
country: United States
facility: Endocrine Assc Long Island PC /ID# 257357
state: New York
city: Greenville
country: United States
facility: Physician's East Endocrinology /ID# 256491
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group /ID# 256869
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research /ID# 256127
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research /ID# 257061
state: North Carolina
city: Salisbury
country: United States
facility: Accellacare - Salisbury /ID# 257019
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare Wilmington /ID# 256744
state: North Carolina
city: Canton
country: United States
facility: Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic - Cleveland /ID# 262392
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center - CarePoint East /ID# 264061
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman /ID# 256785
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Institute of Oklahoma City /ID# 263141
state: Oklahoma
city: Feasterville-Trevose
country: United States
facility: Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital /ID# 256834
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Health - Roosevelt Boulevard /ID# 256837
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Robert Packer Hospital /ID# 261838
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: TMA Headlands LLC /ID# 259800
state: South Carolina
city: North Charleston
country: United States
facility: Carolina Endocrine Associates Llc /ID# 259640
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research - Summerville /ID# 258845
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research /ID# 257631
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research of Knoxville /ID# 256854
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Health Science Center /ID# 259825
state: Tennessee
city: Memphis
country: United States
facility: Lifedoc Research /ID# 262975
state: Tennessee
city: Nashville
country: United States
facility: Mid State Endocrine Associates /ID# 259641
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology - Central Austin /ID# 255728
state: Texas
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology - South Austin /ID# 255723
state: Texas
city: Corpus Christi
country: United States
facility: Brusco, Corpus Christi, TX /ID# 256746
state: Texas
city: Dallas
country: United States
facility: North TX Endocrine Center /ID# 255737
state: Texas
city: Dallas
country: United States
facility: Research Institute Dallas /ID# 256126
state: Texas
city: El Paso
country: United States
facility: Academy of Diabetes, Thyroid and Endocrine /ID# 255735
state: Texas
city: Fort Worth
country: United States
facility: Diabetes and Thyroid Center of Ft. Worth /ID# 256781
state: Texas
city: Houston
country: United States
facility: Juno Research /ID# 259238
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic - Houston - Business Center Drive /ID# 256149
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC /ID# 259221
state: Texas
city: Houston
country: United States
facility: Endocrine and Psychiatry Cente /ID# 259631
state: Texas
city: Irving
country: United States
facility: Tekton Research - Irving /ID# 260988
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates /ID# 256795
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes and Endocrinology /ID# 255722
state: Texas
city: San Antonio
country: United States
facility: Northeast Clinical Research of San Antonio, LLC /ID# 256868
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic /ID# 255734
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC /ID# 256138
state: Texas
city: Weslaco
country: United States
facility: Texas Valley Clinical Research /ID# 261476
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute /ID# 259821
state: Utah
city: South Burlington
country: United States
facility: The University of Vermont Medical Center /ID# 256533
state: Vermont
city: Chesapeake
country: United States
facility: Virginia Endocrinology Research /ID# 259623
state: Virginia
city: Richmond
country: United States
facility: Richmond VA Medical Center /ID# 262386
state: Virginia
city: Salem
country: United States
facility: Salem VA Medical Center /ID# 262387
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research /ID# 255802
state: Washington
city: Spokane
country: United States
facility: MultiCare Rockwood Clinic /ID# 255951
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation /ID# 255954
state: Washington
city: Bayamon
country: Puerto Rico
facility: Clinical Research Investigator Group, LLC /ID# 263177
city: Guaynabo
country: Puerto Rico
facility: ISIS Clinical Research Center /ID# 263182
city: San Juan
country: Puerto Rico
facility: BRCR Global Puerto Rico /ID# 268231
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC /ID# 263183
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research /ID# 263184
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: