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

NCT06345339
clinicaltrials.gov
Phase
Phase 2/Phase 3
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Recruitment status
Recruiting
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Participants
2,800
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Lead sponsor
AbbVie
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Start date
2024-04-26
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Number of sites
139
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Summary
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.
clinicaltrials.gov
Short 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
clinicaltrials.gov
Official title
A Phase 2/3 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
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2028-06-01
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First posted
2024-04-03
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Registry last updated
2026-01-05
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Primary completion date
2027-09-01
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Start date
2024-04-26
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Participants
2,800
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Participant count basis
Estimated
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Planned participants
2,800
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Protocol amendments
1
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Number of sites
139
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AbbVie
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06345339
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ClinicalTrials.gov ID
NCT06345339
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  1. Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response

    Timeframe: Week 55

    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).

  2. Number of Participants with Adverse Events (AEs)

    Timeframe: Up to approximately 90 weeks

    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.

  1. Percentage of Participants who Achieve TSH Response

    Timeframe: Week 55

    TSH response is defined as TSH values falling within 0.45 to 4.12 mIU/L. 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 \[stricter than the one used in the Primary Outcome Measure\]).

  2. Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid

    Timeframe: Up to approximately 29 weeks

    Number of participants needing altered dose conversion from synthetic T4 to Armour Thyroid.

  3. Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period

    Timeframe: Week 55

    Frequency of dose titrations (0,1,2...) during the DB period among participants who achieved TSH response at the end of the DB period.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Central Research Associates /ID# 255719Birmingham, United StatesRecruiting
  • UAB Hospital /ID# 262565Birmingham, United StatesRecruiting
  • Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552Bonita, United StatesRecruiting
  • Facey Medical Foundation - Burbank /ID# 262104Burbank, United StatesRecruiting
  • John Muir Medical Center /ID# 257103Concord, United StatesRecruiting
  • Diagnamics Inc. /ID# 262680Encinitas, United StatesRecruiting
  • Providence - St. Jude Medical Center /ID# 256520Fullerton, United StatesRecruiting
  • NorCal Medical Research /ID# 256512Greenbrae, United StatesRecruiting
  • Velocity Clinical Research - Huntington Park /ID# 259044Huntington Park, United StatesRecruiting
  • Scripps Whittier Diabetes Institute /ID# 259215La Jolla, United StatesRecruiting
  • Facey Medical Foundation /ID# 260863Mission Hills, United StatesRecruiting
  • Hoag Memorial Hospital Presbyterian /ID# 260990Newport Beach, United StatesRecruiting
  • Diabetes Associates Medical Group /ID# 256949Orange, United StatesRecruiting
  • Western University of Health Sciences /ID# 262183Pomona, United StatesRecruiting
  • Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825San Mateo, United StatesRecruiting
  • Care Access - Santa Clarita /ID# 262573Santa Clarita, United StatesRecruiting
  • Facey Medical Foundation - Valencia /ID# 262102Santa Clarita, United StatesRecruiting
  • Olive View UCLA Medical Center /ID# 259092Sylmar, United StatesRecruiting
  • The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572Torrance, United StatesCompleted
  • Diablo Clinical Research /ID# 261329Walnut Creek, United StatesRecruiting
  • San Fernando Valley Health Institute /ID# 257363West Hills, United StatesRecruiting
  • New England Research Associates - Bridgeport /ID# 262184Bridgeport, United StatesRecruiting
  • Innovative Research of West Florida /ID# 257356Clearwater, United StatesRecruiting
  • ALL Medical Research /ID# 256748Cooper City, United StatesRecruiting
  • Northeast Research Institute (NERI) /ID# 261841Fleming Island, United StatesRecruiting

And 114 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (2)