What is Armour Thyroid studying for primary hypothyroidism?

Armour Thyroid is being studied to compare its safety and effectiveness to synthetic T4 in adults with primary hypothyroidism. Researchers want to understand how well patients maintain thyroid hormone levels and tolerate the switch from synthetic T4. This study is sponsored by AbbVie to explore treatment options for thyroid hormone replacement.

Who may be eligible for this hypothyroidism clinical trial?

Adults aged 18 to 75 with a diagnosis of primary hypothyroidism for at least 12 months may be eligible. Participants must be stabilized on a daily synthetic T4 dose for at least 12 months with normal thyroid-stimulating hormone levels. This study includes all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this hypothyroidism clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for those potential costs.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years - 75Years

All Genders

ID06345339

A Phase 23 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

Led by AbbVie · Updated on 2026-01-05

2800

Participants Needed

139

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 23, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone TSH levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.

CONDITIONS

Brief 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

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of primary hypothyroidism made at least 12 months before screening
On continuous synthetic T4 therapy for primary hypothyroidism for at least 12 months before screening
Taking a stable FDA-approved daily dose of synthetic T4 of at least 25 mcg at screening
Have at least one thyroid-stimulating hormone (TSH) test within the normal range (0.45 to 4.12 mIU/L) at screening and at least one additional normal TSH test between 6 weeks and 12 months before screening

You will not qualify if you...

Any clinical condition or previous surgery affecting absorption or processing of Armour Thyroid or synthetic T4
History of alcohol or substance abuse within 6 months before screening
Known or suspected allergy or intolerance to Armour Thyroid, synthetic T4, other thyroid medications, or pork products

Research Team

ABBVIE CALL CENTER

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