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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

Phase 2
Recruiting
Conditions
Hypothyroidism
Interventions
Drug: Armour Thyroid
Drug: Levothyroxine
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
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.
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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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 1Armour ThyroidParticipants will receive Armour Thyroid for up to 81 weeks.
Group 2Armour ThyroidParticipants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.
Group 2LevothyroxineParticipants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.
Primary Outcome Measures
NameTimeMethod
Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) ResponseWeek 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
NameTimeMethod
Percentage of Participants who Achieve TSH ResponseWeek 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 PeriodWeek 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 ThyroidUp 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

πŸ‡΅πŸ‡·

San Juan, Puerto Rico

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

πŸ‡ΊπŸ‡Έ

Torrance, California, United States

Central Research Associates /ID# 255719

πŸ‡ΊπŸ‡Έ

Birmingham, Alabama, United States

UAB Hospital /ID# 262565

πŸ‡ΊπŸ‡Έ

Birmingham, Alabama, United States

Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552

πŸ‡ΊπŸ‡Έ

Bonita, California, United States

Facey Medical Foundation - Burbank /ID# 262104

πŸ‡ΊπŸ‡Έ

Burbank, California, United States

John Muir Medical Center /ID# 257103

πŸ‡ΊπŸ‡Έ

Concord, California, United States

Diagnamics Inc. /ID# 262680

πŸ‡ΊπŸ‡Έ

Encinitas, California, United States

Providence - St. Jude Medical Center /ID# 256520

πŸ‡ΊπŸ‡Έ

Fullerton, California, United States

NorCal Medical Research /ID# 256512

πŸ‡ΊπŸ‡Έ

Greenbrae, California, United States

Velocity Clinical Research - Huntington Park /ID# 259044

πŸ‡ΊπŸ‡Έ

Huntington Park, California, United States

Scripps Whittier Diabetes Institute /ID# 259215

πŸ‡ΊπŸ‡Έ

La Jolla, California, United States

Facey Medical Foundation /ID# 260863

πŸ‡ΊπŸ‡Έ

Mission Hills, California, United States

Hoag Memorial Hospital Presbyterian /ID# 260990

πŸ‡ΊπŸ‡Έ

Newport Beach, California, United States

Diabetes Associates Medical Group /ID# 256949

πŸ‡ΊπŸ‡Έ

Orange, California, United States

Western University of Health Sciences /ID# 262183

πŸ‡ΊπŸ‡Έ

Pomona, California, United States

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

πŸ‡ΊπŸ‡Έ

San Mateo, California, United States

Care Access - Santa Clarita /ID# 262573

πŸ‡ΊπŸ‡Έ

Santa Clarita, California, United States

Facey Medical Foundation - Valencia /ID# 262102

πŸ‡ΊπŸ‡Έ

Santa Clarita, California, United States

Diablo Clinical Research /ID# 261329

πŸ‡ΊπŸ‡Έ

Walnut Creek, California, United States

San Fernando Valley Health Institute /ID# 257363

πŸ‡ΊπŸ‡Έ

West Hills, California, United States

New England Research Associates - Bridgeport /ID# 262184

πŸ‡ΊπŸ‡Έ

Bridgeport, Connecticut, United States

Innovative Research of West Florida /ID# 257356

πŸ‡ΊπŸ‡Έ

Clearwater, Florida, United States

ALL Medical Research /ID# 256748

πŸ‡ΊπŸ‡Έ

Cooper City, Florida, United States

Northeast Research Institute (NERI) /ID# 261841

πŸ‡ΊπŸ‡Έ

Fleming Island, Florida, United States

Northeast Research Institute (NERI) /ID# 261846

πŸ‡ΊπŸ‡Έ

Fleming Island, Florida, United States

The Center for Diabetes and Endocrine Care /ID# 255721

πŸ‡ΊπŸ‡Έ

Fort Lauderdale, Florida, United States

Encore Medical Research LLC /ID# 256758

πŸ‡ΊπŸ‡Έ

Hollywood, Florida, United States

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

πŸ‡ΊπŸ‡Έ

Jacksonville, Florida, United States

The University of Florida Heal /ID# 257361

πŸ‡ΊπŸ‡Έ

Jacksonville, Florida, United States

East Coast Research - Jacksonville /ID# 256971

πŸ‡ΊπŸ‡Έ

Jacksonville, Florida, United States

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

πŸ‡ΊπŸ‡Έ

Jacksonville, Florida, United States

Baptist Health Research Institute /ID# 260989

πŸ‡ΊπŸ‡Έ

Jacksonville, Florida, United States

South Florida Wellness & Clinic /ID# 256513

πŸ‡ΊπŸ‡Έ

Margate, Florida, United States

Ocean Blue Medical Research Center, Inc /ID# 260438

πŸ‡ΊπŸ‡Έ

Miami Springs, Florida, United States

Med Research of Florida /ID# 257837

πŸ‡ΊπŸ‡Έ

Miami, Florida, United States

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

πŸ‡ΊπŸ‡Έ

Mount Dora, Florida, United States

Suncoast Clinical Research Pasco County /ID# 257018

πŸ‡ΊπŸ‡Έ

New Port Richey, Florida, United States

West Orange Endocrinology /ID# 256139

πŸ‡ΊπŸ‡Έ

Ocoee, Florida, United States

Suncoast Clinical Research - Palm Harbor /ID# 256741

πŸ‡ΊπŸ‡Έ

Palm Harbor, Florida, United States

Comprehensive Medical & Research Center /ID# 261678

πŸ‡ΊπŸ‡Έ

Plantation, Florida, United States

Northeast Research Institute - St. Augustine /ID# 261857

πŸ‡ΊπŸ‡Έ

Saint Augustine, Florida, United States

Metabolic Research Inst /ID# 255729

πŸ‡ΊπŸ‡Έ

West Palm Beach, Florida, United States

Grady Clinical Research Center Grady Memorial Hospital /ID# 258419

πŸ‡ΊπŸ‡Έ

Atlanta, Georgia, United States

Atlanta Diabetes Associates /ID# 255736

πŸ‡ΊπŸ‡Έ

Atlanta, Georgia, United States

East Coast Institute for Research - Canton /ID# 256974

πŸ‡ΊπŸ‡Έ

Canton, Georgia, United States

Columbus Regional Research Ins /ID# 255738

πŸ‡ΊπŸ‡Έ

Columbus, Georgia, United States

Physicians Research Associates, LLC /ID# 255675

πŸ‡ΊπŸ‡Έ

Lawrenceville, Georgia, United States

East Coast Institute for Research - Macon /ID# 256529

πŸ‡ΊπŸ‡Έ

Macon, Georgia, United States

Endocrine Research Solutions /ID# 256784

πŸ‡ΊπŸ‡Έ

Roswell, Georgia, United States

Pacific Diabetes & Endocrine Center /ID# 259030

πŸ‡ΊπŸ‡Έ

Honolulu, Hawaii, United States

Rocky Mountain Clinical Research, LLC /ID# 256753

πŸ‡ΊπŸ‡Έ

Idaho Falls, Idaho, United States

Northwestern University Feinberg School of Medicine /ID# 260677

πŸ‡ΊπŸ‡Έ

Chicago, Illinois, United States

West Broadway Clinic /ID# 256756

πŸ‡ΊπŸ‡Έ

Council Bluffs, Iowa, United States

Iowa Diabetes and Endocrinology Research Center /ID# 256750

πŸ‡ΊπŸ‡Έ

West Des Moines, Iowa, United States

Cotton O'Neil Digestive Health Center /ID# 256749

πŸ‡ΊπŸ‡Έ

Topeka, Kansas, United States

L-MARC Research Center /ID# 255733

πŸ‡ΊπŸ‡Έ

Louisville, Kentucky, United States

Pennington Biomedical Research Center /ID# 262390

πŸ‡ΊπŸ‡Έ

Baton Rouge, Louisiana, United States

Nola Care Clinical Research /ID# 260145

πŸ‡ΊπŸ‡Έ

Metairie, Louisiana, United States

Omega Clinical Research /ID# 260162

πŸ‡ΊπŸ‡Έ

Metairie, Louisiana, United States

NECCR PrimaCare Research, LLC /ID# 256531

πŸ‡ΊπŸ‡Έ

Fall River, Massachusetts, United States

Metro Detroit Endocrinology Center /ID# 260862

πŸ‡ΊπŸ‡Έ

Dearborn, Michigan, United States

Michigan Healthcare Professionals /ID# 260859

πŸ‡ΊπŸ‡Έ

Farmington Hills, Michigan, United States

Elite Clinical Research Center /ID# 256782

πŸ‡ΊπŸ‡Έ

Flint, Michigan, United States

Diabetes and Endocrinology Specialists /ID# 259068

πŸ‡ΊπŸ‡Έ

Chesterfield, Missouri, United States

University of Missouri Hospital /ID# 262562

πŸ‡ΊπŸ‡Έ

Columbia, Missouri, United States

Jefferson City Medical Group /ID# 257099

πŸ‡ΊπŸ‡Έ

Jefferson City, Missouri, United States

Washington University-School of Medicine /ID# 262391

πŸ‡ΊπŸ‡Έ

Saint Louis, Missouri, United States

Mercy Research - Springfield /ID# 262385

πŸ‡ΊπŸ‡Έ

Springfield, Missouri, United States

Billings Clinic /ID# 258316

πŸ‡ΊπŸ‡Έ

Billings, Montana, United States

Mercury Street Medical /ID# 259632

πŸ‡ΊπŸ‡Έ

Butte, Montana, United States

Bryan Health Pine Lake Campus /ID# 259638

πŸ‡ΊπŸ‡Έ

Lincoln, Nebraska, United States

Methodist Physicians Clinic /ID# 259276

πŸ‡ΊπŸ‡Έ

Omaha, Nebraska, United States

Palm Research Center /ID# 256131

πŸ‡ΊπŸ‡Έ

Las Vegas, Nevada, United States

Northern Nevada Endocrinology /ID# 259646

πŸ‡ΊπŸ‡Έ

Reno, Nevada, United States

Southern New Hampshire Diabetes and Endocrinology /ID# 257841

πŸ‡ΊπŸ‡Έ

Nashua, New Hampshire, United States

Albany Medical College- Endocrinology Washington Extension /ID# 256794

πŸ‡ΊπŸ‡Έ

Albany, New York, United States

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

πŸ‡ΊπŸ‡Έ

Buffalo, New York, United States

NYC Research /ID# 258662

πŸ‡ΊπŸ‡Έ

New York, New York, United States

Endocrine Assc Long Island PC /ID# 257357

πŸ‡ΊπŸ‡Έ

Smithtown, New York, United States

Physician's East Endocrinology /ID# 256491

πŸ‡ΊπŸ‡Έ

Greenville, North Carolina, United States

Carteret Medical Group /ID# 256869

πŸ‡ΊπŸ‡Έ

Morehead City, North Carolina, United States

Lucas Research /ID# 256127

πŸ‡ΊπŸ‡Έ

Morehead City, North Carolina, United States

Lucas Research /ID# 257061

πŸ‡ΊπŸ‡Έ

Morehead City, North Carolina, United States

Accellacare - Salisbury /ID# 257019

πŸ‡ΊπŸ‡Έ

Salisbury, North Carolina, United States

Accellacare Wilmington /ID# 256744

πŸ‡ΊπŸ‡Έ

Wilmington, North Carolina, United States

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

πŸ‡ΊπŸ‡Έ

Canton, Ohio, United States

Cleveland Clinic - Cleveland /ID# 262392

πŸ‡ΊπŸ‡Έ

Cleveland, Ohio, United States

Lynn Institute of Norman /ID# 256785

πŸ‡ΊπŸ‡Έ

Norman, Oklahoma, United States

Lynn Institute of Oklahoma City /ID# 263141

πŸ‡ΊπŸ‡Έ

Oklahoma City, Oklahoma, United States

Diabetes & Endocrinology Consultants of Pennsylvania /ID# 259064

πŸ‡ΊπŸ‡Έ

Feasterville-Trevose, Pennsylvania, United States

Thomas Jefferson University Hospital /ID# 256834

πŸ‡ΊπŸ‡Έ

Philadelphia, Pennsylvania, United States

Jefferson Health - Roosevelt Boulevard /ID# 256837

πŸ‡ΊπŸ‡Έ

Philadelphia, Pennsylvania, United States

Guthrie Robert Packer Hospital /ID# 261838

πŸ‡ΊπŸ‡Έ

Sayre, Pennsylvania, United States

Trial Management Associates - Myrtle Beach /ID# 259800

πŸ‡ΊπŸ‡Έ

Myrtle Beach, South Carolina, United States

Carolina Endocrine Associates Llc /ID# 259640

πŸ‡ΊπŸ‡Έ

North Charleston, South Carolina, United States

Palmetto Clinical Research - Summerville /ID# 258845

πŸ‡ΊπŸ‡Έ

Summerville, South Carolina, United States

Chattanooga Medical Research /ID# 257631

πŸ‡ΊπŸ‡Έ

Chattanooga, Tennessee, United States

PMG Research of Knoxville /ID# 256854

πŸ‡ΊπŸ‡Έ

Knoxville, Tennessee, United States

University of Tennessee Health Science Center /ID# 259825

πŸ‡ΊπŸ‡Έ

Memphis, Tennessee, United States

Mid State Endocrine Associates /ID# 259641

πŸ‡ΊπŸ‡Έ

Nashville, Tennessee, United States

Texas Diabetes and Endocrinology - Central Austin /ID# 255728

πŸ‡ΊπŸ‡Έ

Austin, Texas, United States

Texas Diabetes and Endocrinology - South Austin /ID# 255723

πŸ‡ΊπŸ‡Έ

Austin, Texas, United States

Brusco, Corpus Christi, TX /ID# 256746

πŸ‡ΊπŸ‡Έ

Corpus Christi, Texas, United States

North TX Endocrine Center /ID# 255737

πŸ‡ΊπŸ‡Έ

Dallas, Texas, United States

Research Institute Dallas /ID# 256126

πŸ‡ΊπŸ‡Έ

Dallas, Texas, United States

Academy of Diabetes, Thyroid and Endocrine /ID# 255735

πŸ‡ΊπŸ‡Έ

El Paso, Texas, United States

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

πŸ‡ΊπŸ‡Έ

Fort Worth, Texas, United States

Juno Research /ID# 259238

πŸ‡ΊπŸ‡Έ

Houston, Texas, United States

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

πŸ‡ΊπŸ‡Έ

Houston, Texas, United States

PlanIt Research, PLLC /ID# 259221

πŸ‡ΊπŸ‡Έ

Houston, Texas, United States

Endocrine and Psychiatry Cente /ID# 259631

πŸ‡ΊπŸ‡Έ

Houston, Texas, United States

Tekton Research /ID# 260988

πŸ‡ΊπŸ‡Έ

Irving, Texas, United States

Southern Endocrinology Associates /ID# 256795

πŸ‡ΊπŸ‡Έ

Mesquite, Texas, United States

Texas Diabetes and Endocrinology /ID# 255722

πŸ‡ΊπŸ‡Έ

Round Rock, Texas, United States

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

πŸ‡ΊπŸ‡Έ

San Antonio, Texas, United States

Diabetes & Glandular Disease Clinic /ID# 255734

πŸ‡ΊπŸ‡Έ

San Antonio, Texas, United States

Consano Clinical Research, LLC /ID# 256138

πŸ‡ΊπŸ‡Έ

Shavano Park, Texas, United States

Texas Valley Clinical Research /ID# 261476

πŸ‡ΊπŸ‡Έ

Weslaco, Texas, United States

Advanced Research Institute /ID# 259821

πŸ‡ΊπŸ‡Έ

Ogden, Utah, United States

Virginia Endocrinology Research /ID# 259623

πŸ‡ΊπŸ‡Έ

Chesapeake, Virginia, United States

ISIS Clinical Research Center /ID# 263182

πŸ‡΅πŸ‡·

Guaynabo, Puerto Rico

Salem VA Medical Center /ID# 262387

πŸ‡ΊπŸ‡Έ

Salem, Virginia, United States

Rainier Clinical Research /ID# 255802

πŸ‡ΊπŸ‡Έ

Renton, Washington, United States

MultiCare Rockwood Clinic /ID# 255951

πŸ‡ΊπŸ‡Έ

Spokane, Washington, United States

MultiCare Institute for Research & Innovation /ID# 255954

πŸ‡ΊπŸ‡Έ

Tacoma, Washington, United States

Clinical Research Investigator Group, LLC /ID# 263177

πŸ‡΅πŸ‡·

Bayamon, Puerto Rico

GCM Medical Group, PSC /ID# 263183

πŸ‡΅πŸ‡·

San Juan, Puerto Rico

Mindful Medical Research /ID# 263184

πŸ‡΅πŸ‡·

San Juan, Puerto Rico

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