NCT07747103 An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.
| NCT ID | NCT07747103 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Neuvosyn Laboratories, LLC |
| Condition | Hypothyroidism |
| Study Type | INTERVENTIONAL |
| Enrollment | 466 participants |
| Start Date | 2026-06-30 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 466 participants in total. It began in 2026-06-30 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07747103 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hypothyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07747103 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 466 participants.
Is NCT07747103 currently recruiting?
Yes, NCT07747103 is actively recruiting participants. Visit ClinicalTrials.gov or contact Neuvosyn Laboratories, LLC to inquire about joining.
Where is the NCT07747103 trial being conducted?
This trial is being conducted at Modesto, United States, Redding, United States, San Diego, United States, Walnut Creek, United States and 11 additional locations.
Who is sponsoring the NCT07747103 clinical trial?
NCT07747103 is sponsored by Neuvosyn Laboratories, LLC. The trial plans to enroll 466 participants.