North Star desiccated porcine thyroid tablets for primary hypothyroidism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm Phase 3 trial evaluating the efficacy and safety of North Star desiccated porcine thyroid extract tablets in adults with primary hypothyroidism. Eligible participants must have been on a stable LT4 dose for at least 12 weeks and in euthyroid status within the prior 6 weeks to 12 months. The study will monitor thyroid-related outcomes and safety over time in multiple centers. Key exclusions include conditions or surgeries that affect drug absorption or metabolism, recent major illness requiring hospitalization, or use of prohibited medications. The lead sponsor is Neuvosyn Laboratories, with sites in Modesto, Redding, and San Diego, CA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• AppleMed Research Group, LLC
  Miami, Florida, United States Recruiting
• Advanced Medical Research Institute, LLC
  Miami, Florida, United States Recruiting
• Paradigm Clinical Research Centers, LLC
  Modesto, California, United States Not yet recruiting
• Paradigm Clinical Research Centers, LLC
  Redding, California, United States Not yet recruiting
• Paradigm Clinical Research Centers, LLC
  San Diego, California, United States Not yet recruiting
• Sunwise Clinical Research
  Walnut Creek, California, United States Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.