Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 where the thyroid gland does not produce enough thyroid hormone. It is being studied in adult participants with primary hypothyroidism. The drug is currently in Phase 2 clinical development and is not yet approved by the FDA.
Armour Thyroid is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating hypothyroidism.
Armour Thyroid is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. There are two Phase 2 trials, one completed and one currently recruiting participants, studying the drug for the treatment of hypothyroidism.
Armour Thyroid is being studied in two clinical trials. NCT04124705 is a completed Phase 2 study comparing Armour Thyroid to synthetic T4 (levothyroxine) in previously hypothyroid participants, with 284 enrolled. NCT06345339 is a recruiting Phase 2 study assessing safety and efficacy versus synthetic T4 in primary hypothyroidism, with a target enrollment of 2800.
No, Armour Thyroid is not the same as levothyroxine. Armour Thyroid is a natural thyroid extract, while levothyroxine is a synthetic form of the thyroid hormone T4. Clinical trials are comparing Armour Thyroid directly against levothyroxine to evaluate its safety and efficacy in treating hypothyroidism.