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

Recruiting now · Phase 2/Phase 3

Conditions studied: Hypothyroidism

In brief

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.

Key facts

Study ID

NCT06345339

Run by

AbbVie

People needed

2800

Starts

2024-04-26

Expected to finish

2028-06-01

Last updated by the study team

2026-01-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Central Research Associates /ID# 255719 — Birmingham, Alabama, United States (enrolling)
• Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552 — Bonita, California, United States (enrolling)
• UAB Hospital /ID# 262565 — Birmingham, Alabama, United States (enrolling)
• John Muir Medical Center /ID# 257103 — Concord, California, United States (enrolling)
• Diagnamics Inc. /ID# 262680 — Encinitas, California, United States (enrolling)
• Providence - St. Jude Medical Center /ID# 256520 — Fullerton, California, United States (enrolling)
• NorCal Medical Research /ID# 256512 — Greenbrae, California, United States (enrolling)
• Facey Medical Foundation - Burbank /ID# 262104 — Burbank, California, United States (enrolling)
• Scripps Whittier Diabetes Institute /ID# 259215 — La Jolla, California, United States (enrolling)
• Facey Medical Foundation /ID# 260863 — Mission Hills, California, United States (enrolling)
• Hoag Memorial Hospital Presbyterian /ID# 260990 — Newport Beach, California, United States (enrolling)
• Diabetes Associates Medical Group /ID# 256949 — Orange, California, United States (enrolling)
• Western University of Health Sciences /ID# 262183 — Pomona, California, United States (enrolling)
• Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825 — San Mateo, California, United States (enrolling)
• Care Access - Santa Clarita /ID# 262573 — Santa Clarita, California, United States (enrolling)
• Facey Medical Foundation - Valencia /ID# 262102 — Santa Clarita, California, United States (enrolling)
• Olive View UCLA Medical Center /ID# 259092 — Sylmar, California, United States (enrolling)
• Velocity Clinical Research - Huntington Park /ID# 259044 — Huntington Park, California, United States (enrolling)
• Diablo Clinical Research /ID# 261329 — Walnut Creek, California, United States (enrolling)
• San Fernando Valley Health Institute /ID# 257363 — West Hills, California, United States (enrolling)
• New England Research Associates - Bridgeport /ID# 262184 — Bridgeport, Connecticut, United States (enrolling)
• Innovative Research of West Florida /ID# 257356 — Clearwater, Florida, United States (enrolling)
• ALL Medical Research /ID# 256748 — Cooper City, Florida, United States (enrolling)
• Northeast Research Institute (NERI) /ID# 261841 — Fleming Island, Florida, United States (enrolling)
• Northeast Research Institute (NERI) /ID# 261846 — Fleming Island, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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