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NCT06345339

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

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

2800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-26

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypothyroidism

Keywords

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Hypothyroidism Armour Thyroid Synthetic T4

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1

Participants will receive Armour Thyroid for up to 81 weeks.

Group Type EXPERIMENTAL

Armour Thyroid

Intervention Type DRUG

Oral Capsule or Tablet

Group 2

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

Group Type EXPERIMENTAL

Armour Thyroid

Intervention Type DRUG

Oral Capsule or Tablet

Levothyroxine

Intervention Type DRUG

Oral Capsule

Interventions

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Armour Thyroid

Oral Capsule or Tablet

Intervention Type DRUG

Levothyroxine

Oral Capsule

Intervention Type DRUG

Other Intervention Names

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AGN-282176 Synthetic T4

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Central Research Associates /ID# 255719

Birmingham, Alabama, United States

Site Status RECRUITING

UAB Hospital /ID# 262565

Birmingham, Alabama, United States

Site Status RECRUITING

Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552

Bonita, California, United States

Site Status RECRUITING

Facey Medical Foundation - Burbank /ID# 262104

Burbank, California, United States

Site Status RECRUITING

John Muir Medical Center /ID# 257103

Concord, California, United States

Site Status RECRUITING

Diagnamics Inc. /ID# 262680

Encinitas, California, United States

Site Status RECRUITING

Providence - St. Jude Medical Center /ID# 256520

Fullerton, California, United States

Site Status RECRUITING

NorCal Medical Research /ID# 256512

Greenbrae, California, United States

Site Status RECRUITING

Velocity Clinical Research - Huntington Park /ID# 259044

Huntington Park, California, United States

Site Status RECRUITING

Scripps Whittier Diabetes Institute /ID# 259215

La Jolla, California, United States

Site Status RECRUITING

Facey Medical Foundation /ID# 260863

Mission Hills, California, United States

Site Status RECRUITING

Hoag Memorial Hospital Presbyterian /ID# 260990

Newport Beach, California, United States

Site Status RECRUITING

Diabetes Associates Medical Group /ID# 256949

Orange, California, United States

Site Status RECRUITING

Western University of Health Sciences /ID# 262183

Pomona, California, United States

Site Status RECRUITING

Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825

San Mateo, California, United States

Site Status RECRUITING

Care Access - Santa Clarita /ID# 262573

Santa Clarita, California, United States

Site Status RECRUITING

Facey Medical Foundation - Valencia /ID# 262102

Santa Clarita, California, United States

Site Status RECRUITING

Olive View UCLA Medical Center /ID# 259092

Sylmar, California, United States

Site Status RECRUITING

The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572

Torrance, California, United States

Site Status COMPLETED

Diablo Clinical Research /ID# 261329

Walnut Creek, California, United States

Site Status RECRUITING

San Fernando Valley Health Institute /ID# 257363

West Hills, California, United States

Site Status RECRUITING

New England Research Associates - Bridgeport /ID# 262184

Bridgeport, Connecticut, United States

Site Status RECRUITING

Innovative Research of West Florida /ID# 257356

Clearwater, Florida, United States

Site Status RECRUITING

ALL Medical Research /ID# 256748

Cooper City, Florida, United States

Site Status RECRUITING

Northeast Research Institute (NERI) /ID# 261841

Fleming Island, Florida, United States

Site Status RECRUITING

Northeast Research Institute (NERI) /ID# 261846

Fleming Island, Florida, United States

Site Status RECRUITING

The Center for Diabetes and Endocrine Care /ID# 255721

Fort Lauderdale, Florida, United States

Site Status RECRUITING