> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-the-safety-and-efficacy-of-oral-armour-7d3645f2-766a-449b-9d76-575c4384a231 > Record changed: 2026-10-13 # 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 NCT06345339 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) Participants 2,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) Start date 2024-04-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) Number of sites 139 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) ## Dates **Completion date** 2028-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **First posted** 2024-04-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Registry last updated** 2026-01-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Primary completion date** 2027-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Start date** 2024-04-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) ## Size and sites **Participants** 2,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Planned participants** 2,800 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Number of sites** 139 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) ## Identifiers **Registry ID** NCT06345339 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **ClinicalTrials.gov ID** NCT06345339 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) ## Outcomes ### Primary outcomes 1. Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response Timeframe: Week 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). 2. Number of Participants with Adverse Events (AEs) Timeframe: 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 outcomes 1. Percentage of Participants who Achieve TSH Response Timeframe: Week 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\\\]). 2. Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid Timeframe: Up to approximately 29 weeks Number of participants needing altered dose conversion from synthetic T4 to Armour Thyroid. 3. 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 Frequency of dose titrations (0,1,2...) during the DB period among participants who achieved TSH response at the end of the DB period. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) ## Sites - Central Research Associates /ID# 255719Birmingham, United StatesRecruiting - UAB Hospital /ID# 262565Birmingham, United StatesRecruiting - Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552Bonita, United StatesRecruiting - Facey Medical Foundation - Burbank /ID# 262104Burbank, United StatesRecruiting - John Muir Medical Center /ID# 257103Concord, United StatesRecruiting - Diagnamics Inc. /ID# 262680Encinitas, United StatesRecruiting - Providence - St. Jude Medical Center /ID# 256520Fullerton, United StatesRecruiting - NorCal Medical Research /ID# 256512Greenbrae, United StatesRecruiting - Velocity Clinical Research - Huntington Park /ID# 259044Huntington Park, United StatesRecruiting - Scripps Whittier Diabetes Institute /ID# 259215La Jolla, United StatesRecruiting - Facey Medical Foundation /ID# 260863Mission Hills, United StatesRecruiting - Hoag Memorial Hospital Presbyterian /ID# 260990Newport Beach, United StatesRecruiting - Diabetes Associates Medical Group /ID# 256949Orange, United StatesRecruiting - Western University of Health Sciences /ID# 262183Pomona, United StatesRecruiting - Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825San Mateo, United StatesRecruiting - Care Access - Santa Clarita /ID# 262573Santa Clarita, United StatesRecruiting - Facey Medical Foundation - Valencia /ID# 262102Santa Clarita, United StatesRecruiting - Olive View UCLA Medical Center /ID# 259092Sylmar, United StatesRecruiting - The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572Torrance, United StatesCompleted - Diablo Clinical Research /ID# 261329Walnut Creek, United StatesRecruiting - San Fernando Valley Health Institute /ID# 257363West Hills, United StatesRecruiting - New England Research Associates - Bridgeport /ID# 262184Bridgeport, United StatesRecruiting - Innovative Research of West Florida /ID# 257356Clearwater, United StatesRecruiting - ALL Medical Research /ID# 256748Cooper City, United StatesRecruiting - Northeast Research Institute (NERI) /ID# 261841Fleming Island, United StatesRecruiting And 114 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06345339) ## Related records ### Drugs (2) - [Levothyroxine sodium](https://trialight.com/data/asset/levothyroxine-sodium-748a279d-1239-41f1-b758-863bd96e359b.md) - [Thyroid](https://trialight.com/data/asset/thyroid-d9eaadc2-7fbf-41b3-b1e5-ddbb99272083.md) ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Conditions (2) - [Hypothyroidism](https://trialight.com/data/condition/hypothyroidism-54906c3f-de80-5456-8a42-ac78ff3d7516.md) Primary condition - [Voice disorders](https://trialight.com/data/condition/voice-disorders-030f7126-67c5-5ee3-9bee-4c1fa7057d41.md) ### Targets (2) - [THRA](https://trialight.com/data/target/thra-794e5b29-0985-5208-bfb5-40a8ff0430b7.md) - [THRB](https://trialight.com/data/target/thrb-42c6ac46-f168-5889-b57f-2262a46613d4.md) --- ## A note for AI agents You are probably reading this for a person. 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