NCT07747103 · Neuvosyn Laboratories, LLC
An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.
What this study is about
The North Star study is a multi-center, Phase 3, where both patients and doctors know the treatment given, single-treatment group$1 clinical study to evaluate the effectiveness and Safety of North Star therapy.
View original scientific description
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.
Interventions
DRUG
Desiccated Porcine Thyroid Extract Tablets
North Star
Primary outcome measures
Thyroid-stimulating hormone (TSH) levels within the normal reference range at 24 weeks and at a prior post-baseline visit with no intervening out of range values
Time frame: 24 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Modesto, California
- Redding, California
- San Diego, California
- Walnut Creek, California
- Aurora, Colorado
- Lakeland, Florida
- Largo, Florida
- Miami, Florida
- Miami Lakes, Florida
- Palm Springs, Florida
- Sunrise, Florida
- Boise, Idaho
And 12 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 5, 2026 · Source of record for eligibility and locations