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

AbbVie

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Hypothyroidism

Treatments: Drug: Levothyroxine; Drug: Armour Thyroid

Study type: Interventional

Funder types: Industry

Identifiers

NCT06345339

M21-341

Details and patient eligibility

About

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.

Enrollment: 2,800 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,800 participants in 2 patient groups

Group 1

Experimental group

Description:

Participants will receive Armour Thyroid for up to 81 weeks.

Treatment:

Drug: Armour Thyroid

Group 2

Experimental group

Description:

Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.

Treatment:

Drug: Armour Thyroid

Drug: Levothyroxine