RecruitingHypothyroidism

An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.

Eligible age

18–75 yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

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.

Sponsor: Neuvosyn Laboratories, LLC

✓ 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
✓ Agree to practice a method of contraception of greater than 90% reliability
✓ Willing to give written informed consent for the Study
✓ Provide written authorization for use and disclosure of protected health information

✕ 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
✕ Taking or having taken prescription or over-the-counter weight loss medications within 6 weeks prior to Screening
✕ Participated in another investigational new drug study within 30 days or 5 half-lives of the IMP, whichever is longer, prior to the first study drug administration.
✕ For female subjects, be pregnant, nursing or planning to become pregnant during the study