The North Star study is a multi-center, Phase 3, open-label, single-arm clinical study to evaluate the Efficacy and Safety of North Star therapy.
Diagnosed with primary hypothyroidism, including Hashimoto's Thyroiditis, and on therapy with a stable dose of LT4 (minimum 50 mcg per day, administered 7 days per week) for at least 12 weeks prior to Screening
Have had euthyroid status for at least 6 weeks and up to 12 months prior to Screening (Visit 1), with at least one documented minimum stable dose of 50 mcg LT4.
Agree to practice a method of contraception
Female patients not pregnant or lactating at Screening
Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of North Star
Hospitalization for a major illness within 5 weeks prior to Screening
Concomitant use of prohibited medications or supplements
Have uncontrolled diabetes