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Also known as AGN-282176, Desiccated thyroid extract, AGN-204771
Armour Thyroid · 2 trials · 5 indications
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).
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.
Sustained TSH response is defined as TSH values that are within the normal reference range of 0.45 to 4.12 mIU/L, inclusive, at both the end of Titration Period and the end of the Stabilization Period.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Participants will receive Armour Thyroid for up to 81 weeks. |
| Group 2 | EXPERIMENTAL | Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. |
| Armour® Thyroid | EXPERIMENTAL | Participants were randomized to receive Armour Thyroid at a dose corresponding to their pre-randomized dose of synthetic T4. During the first 18 to 36 weeks (titration period) the dose of Armour Thyroid could be titrated based on levels of thyroid stimulating hormone (TSH), in order to achieve TSH levels within the normal reference range (0.45 - 4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of Armour Thyroid for an additional 12 weeks (stabilization period). |
| Levothyroxine | ACTIVE_COMPARATOR | Participants were randomized to receive levothyroxine at their pre-randomized dose. During the first 18 to 36 weeks (titration period) the dose of levothyroxine could be titrated based on levels of TSH in order to achieve TSH levels within the normal reference range (0.45-4.12 mIU/L, inclusive). Once TSH levels were within the normal reference range, participants continued to receive a stable dose of levothyroxine for an additional 12 weeks (stabilization period). |
| Name | Type | Description |
|---|---|---|
| Armour Thyroid | DRUG | Oral Capsule or Tablet |
| Levothyroxine | DRUG | Oral Capsule |
| Armour® Thyroid | DRUG | Administered orally once a day. the daily dose could range from 1/4 - 2 grains. |
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...
Armour Thyroid is used for the treatment of hypothyroidism, a condition in which the thyroid gland does not produce enough thyroid hormone. It is being studied in adults with primary hypothyroidism and in previously hypothyroid participants. The clinical program focuses on the endocrine therapeutic area.
Armour Thyroid is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical trials evaluating the therapy in hypothyroidism.
Armour Thyroid is in Phase 2 clinical development. It is an investigational small molecule being studied for hypothyroidism, and it has not been approved for the studied use based on the available development information. Two Phase 2 trials have been conducted, one of which is still active.
Armour Thyroid has been evaluated in two Phase 2 trials. NCT06345339 is an active, not recruiting study comparing oral Armour Thyroid to synthetic T4 in adults with primary hypothyroidism, enrolling 2,701 participants in the United States and Puerto Rico. NCT04124705 is a completed Phase 2 study comparing Armour Thyroid to levothyroxine in previously hypothyroid participants, enrolling 284.
Yes, Armour Thyroid and Armour® Thyroid refer to the same product. The registered trademark symbol is simply a stylized version of the name. Both names are used interchangeably in the context of the hypothyroidism clinical program developed by AbbVie.