Status:
RECRUITING
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
Lead Sponsor:
AbbVie
Conditions:
Hypothyroidism
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
2800 Patients enrolled
Trial Details
Trial ID
NCT06345339
Start Date
April 26 2024
End Date
June 1 2028
Last Update
January 5 2026
Active Locations (139)
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1
Central Research Associates /ID# 255719
Birmingham, Alabama, United States, 35205
2
UAB Hospital /ID# 262565
Birmingham, Alabama, United States, 35233-1932
3
Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552
Bonita, California, United States, 91902-1230
4
Facey Medical Foundation - Burbank /ID# 262104
Burbank, California, United States, 91505-4554