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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 2,800
- Locations
- 275
- Primary Endpoint
- Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 T
- •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.
Arms & Interventions
Group 2
Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.
Intervention: Armour Thyroid (Drug)
Group 1
Participants will receive Armour Thyroid for up to 81 weeks.
Intervention: Armour Thyroid (Drug)
Group 2
Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.
Intervention: Levothyroxine (Drug)
Outcomes
Primary Outcomes
Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response
Time Frame: 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).
Number of Participants with Adverse Events (AEs)
Time Frame: 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.
Secondary Outcomes
- Percentage of Participants who Achieve TSH Response(Week 55)
- Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period(Week 55)
- Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid(Up to approximately 29 weeks)