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

Recruiting now · Phase 3

Conditions studied: Hypothyroidism

In brief

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.

Key facts

Study ID

NCT07747103

Run by

Neuvosyn Laboratories, LLC

People needed

466

Starts

2026-06-30

Expected to finish

2027-12-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• AppleMed Research Group, LLC — Miami, Florida, United States (enrolling)
• Advanced Medical Research Institute, LLC — Miami, Florida, United States (enrolling)
• Paradigm Clinical Research Centers, LLC — San Diego, California, United States
• Sunwise Clinical Research — Walnut Creek, California, United States
• Paradigm Clinical Research Centers, LLC — Aurora, Colorado, United States
• Accel Research — Lakeland, Florida, United States
• Accel Research — Largo, Florida, United States
• 3Sync LLC — Miami Lakes, Florida, United States
• 3Sync Research — Palm Springs, Florida, United States
• Precision Clinical Research — Sunrise, Florida, United States
• Paradigm Clinical Research Centers, LLC — Boise, Idaho, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• ActivMed Practices and Research — Methuen, Massachusetts, United States
• M3 Wake Research - Las Vegas Wellness Way — Las Vegas, Nevada, United States
• M3 Wake Research — Raleigh, North Carolina, United States
• Progressive Medicine of the Triad, LLC — Winston-Salem, North Carolina, United States
• M3 Wake Research — Charleston, South Carolina, United States
• Coastal Carolina Research Center, LLC — North Charleston, South Carolina, United States
• M3 Wake Research — Chattanooga, Tennessee, United States
• M3 Wake Research — Dallas, Texas, United States
• Advanced Medical Trials, LLC — Georgetown, Texas, United States
• Olympus Clinical Research — Sugar Land, Texas, United States
• Paradigm Clinical Research Centers, LLC — Modesto, California, United States
• Charlotteville Medical Research Center, LLC — Charlottesville, Virginia, United States
• Paradigm Clinical Research Centers, LLC — Redding, California, United States

Full record on ClinicalTrials.gov

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