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
Launched by ABBVIE · Mar 27, 2024
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the safety and effectiveness of a medication called Armour Thyroid, which is a natural treatment for hypothyroidism, compared to a synthetic thyroid hormone known as synthetic T4. The trial is focused on adults who have been diagnosed with primary hypothyroidism and have been successfully managing their condition with synthetic T4 for at least a year. The goal is to see how well participants can switch from synthetic T4 to Armour Thyroid without any issues.
To be eligible for this study, participants need to have a confirmed diagnosis of primary hypothyroidism for at least a year and must have been on a stable dose of synthetic T4 for the past 12 months. They should also have normal thyroid hormone levels, as indicated by specific blood tests. During the trial, participants will receive either Armour Thyroid or continue with synthetic T4 and will be monitored closely for their overall health and thyroid function. This study is currently recruiting individuals aged 18 and older, and it's important to note that those with certain medical conditions or allergies may not be able to participate.
Gender
ALL
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.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Encinitas, California, United States
Greenbrae, California, United States
Ocoee, Florida, United States
Roswell, Georgia, United States
Council Bluffs, Iowa, United States
Louisville, Kentucky, United States
Greenville, North Carolina, United States
Canton, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Austin, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Shavano Park, Texas, United States
Weslaco, Texas, United States
West Palm Beach, Florida, United States
New York, New York, United States
Morehead City, North Carolina, United States
Houston, Texas, United States
Round Rock, Texas, United States
Margate, Florida, United States
Smithtown, New York, United States
Renton, Washington, United States
Plantation, Florida, United States
Nashville, Tennessee, United States
El Paso, Texas, United States
Mesquite, Texas, United States
Fall River, Massachusetts, United States
Bridgeport, Connecticut, United States
Fleming Island, Florida, United States
Jacksonville, Florida, United States
Mount Dora, Florida, United States
Saint Augustine, Florida, United States
Canton, Georgia, United States
Butte, Montana, United States
Morehead City, North Carolina, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Macon, Georgia, United States
Buffalo, New York, United States
Clearwater, Florida, United States
Fleming Island, Florida, United States
Palm Harbor, Florida, United States
Dearborn, Michigan, United States
Flint, Michigan, United States
Chattanooga, Tennessee, United States
Irving, Texas, United States
Birmingham, Alabama, United States
New Port Richey, Florida, United States
Topeka, Kansas, United States
Jefferson City, Missouri, United States
Houston, Texas, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
West Des Moines, Iowa, United States
Cooper City, Florida, United States
Lawrenceville, Georgia, United States
Wilmington, North Carolina, United States
Houston, Texas, United States
Jacksonville, Florida, United States
Las Vegas, Nevada, United States
Metairie, Louisiana, United States
Metairie, Louisiana, United States
Myrtle Beach, South Carolina, United States
Chesapeake, Virginia, United States
North Charleston, South Carolina, United States
Santa Clarita, California, United States
Walnut Creek, California, United States
Morehead City, North Carolina, United States
Columbus, Georgia, United States
Concord, California, United States
West Hills, California, United States
Hollywood, Florida, United States
Fort Lauderdale, Florida, United States
Idaho Falls, Idaho, United States
Billings, Montana, United States
Philadelphia, Pennsylvania, United States
San Antonio, Texas, United States
Orange, California, United States
Nashua, New Hampshire, United States
Corpus Christi, Texas, United States
Huntington Park, California, United States
La Jolla, California, United States
Pomona, California, United States
Miami Springs, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Farmington Hills, Michigan, United States
Chesterfield, Missouri, United States
Columbia, Missouri, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Reno, Nevada, United States
Salisbury, North Carolina, United States
Feasterville Trevose, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Summerville, South Carolina, United States
Knoxville, Tennessee, United States
Ogden, Utah, United States
Tacoma, Washington, United States
Bayamon, , Puerto Rico
Guaynabo, , Puerto Rico
Saint Louis, Missouri, United States
Jacksonville, Florida, United States
Honolulu, Hawaii, United States
Fullerton, California, United States
Mission Hills, California, United States
Jacksonville, Florida, United States
Saint Augustine, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Baton Rouge, Louisiana, United States
Albany, New York, United States
Sayre, Pennsylvania, United States
Spokane, Washington, United States
San Juan, , Puerto Rico
Birmingham, Alabama, United States
Burbank, California, United States
Santa Clarita, California, United States
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Bonita, California, United States
Baton Rouge, Louisiana, United States
Memphis, Tennessee, United States
Newport Beach, California, United States
Salem, Virginia, United States
San Mateo, California, United States
Cleveland, Ohio, United States
Springfield, Missouri, United States
Torrance, California, United States
Houston, Texas, United States
South Burlington, Vermont, United States
West Des Moines, Iowa, United States
Topeka, Kansas, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
Irving, Texas, United States
Richmond, Virginia, United States
Memphis, Tennessee, United States
Dracut, Massachusetts, United States
St. Augustine, Florida, United States
St. Louis, Missouri, United States
St.Louis, Missouri, United States
Louisville, Kentucky, United States
Columbus, Ohio, United States
Myrtle Beach, South Carolina, United States
Louisville, Kentucky, United States
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported