IRB Study Number 24-748
Status Recruiting
Phases Phase 2, Phase 3
Institute Endocrinology and Metabolism Institute
Description
The primary efficacy objective of this study is to demonstrate that the Armour Thyroid treatment group is non-inferior to the synthetic T4 treatment group.
Inclusion Criteria
Subjects must be ≥ 18 to ≤ 75 years of age, inclusive, at the time of consent.
A diagnosis of primary hypothyroidism made ≥ 12 months prior to screening.
Note: Subjects who have undergone total thyroidectomy for treatment of thyroid cancer may be eligible for enrollment if they meet the following:
a) Are > 5 years from date of total thyroidectomy or last thyroid surgery, and
b) Have no clinical evidence of recurrence, and
c) Have had serial measurements of thyroglobulin and anti-thyroglobulin since the time of surgery or treatment with radioactive iodine.
i. All values should have been undetectable after surgery or starting 6 months after treatment with radioactive iodine,
ii. At least 1 historical measurement with undetectable values,
iii. Including undetectable values obtained at the screening visit
Be on continuous thyroid replacement therapy of synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to Screening.
Be on a stable (i.e. dose not changed for at least 3 months prior) FDA-approved _daily _dose of synthetic T4 for a minimum of 3 months prior to screening and must be taking synthetic T4 dose of at least __25 mcg at screening. *Must enter the study at the same stable dose to determine dose conversion.
Have documentation of 1 in-range TSH (.45-4.12mIU/L, inclusive) at Screening and at least 1 additional in-range TSH taken a minimum at 6 weeks and maximum of 12 months prior.
BMI between 18 and 40 (inclusive) at Screening.
For all females of child-bearing potential; a negative serum pregnancy test at screening
Females of child bearing potential must practice at least 1 protocol-specified method of birth control. Females of non-childbearing potential do not need to use birth control.
Female who is ++not ++pregnant or breastfeeding, and is ++not++ considering becoming pregnant or donating eggs during the study or for ++at least++ 35 days after their final dose of study drug.
Subjects must voluntarily sign and date an IRB approved informed consent
Willingness and ability to attend all study visits, comply with study procedures, read and complete questionnaires, and be able to complete the study period as assessed by the Investigator.
Exclusion Criteria
Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion or 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 it excipients, synthetic T4, other thyroid replacement medications, or pork products.
Have taken any prohibited concomitant medications that cannot meet the discontinuation requirements.
Prohibited medications:
- 12-month discontinuation period: Liothyronine sodium (Cytomel, Triostat); Methimazole (Tapazole); Propylthiouracil; Desiccated thyroid medications (Armour, NP thyroid, Adthiza); Thyroid supplements/extracts; Sodium Iodide I-131 (for use as ablative therapy of thyroid gland); Potassium Iodide (Lugol's solution)
§ 6-month discontinuation period: Amiodarone
- 7 days prior to clinical laboratory testing: biotin and/or biotin containing supplements
Have received active treatment with an investigational drug within 30 days or 5 half-lives, whichever is longer, of Screening Visit.
Subject cannot be taking a daily dose of synthetic T4 that exceeds 200 mcg at Screening.
Current enrollment in an investigational drug or device study or participation in such a study within 60 days of entry into this study or is currently enrolled in another investigational clinical study or was previously enrolled in this study. Once a subject is enrolled in the study, they may not participate in another investigational drug trial during this trial.
Clinically significant results according to the Investigator or designee, on physical examination, medical history, ECG, hematology, clinical chemistry, or urinalysis that may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
Sitting systolic BP [≥ 140 mm Hg or ≤ 90 mm Hg] or sitting diastolic BP [≥ 90 mm Hg or ≤ 50 mm Hg] at the Screening.
Note: A total of 3 readings of BP and pulse will be taken. The first reading should be rejected. If either the second or third reading meets exclusion criteria, the subject should be excluded.
Abnormal clinically relevant of significant ECG abnormalities, including ECG with QT interval correct for heart rate (QTc) using Fridericia’s formula (QTcF) ≥ 450 msec (males)or ≥ 470 msec (females).
The subject has a concurrent disease, condition, or is in a situation which, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
Any medical history or current clinical evidence or decompensatory cirrhosis such as hepatic encephalopathy, variceal bleeding, and ascites.
Any patient currently receiving dialysis treatment.
