An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.
Key facts
- Where
- Aurora, Boise, Boston, Charleston, Charlottesville, Chattanooga, Dallas, Georgetown, Lakeland, Largo, Las Vegas, Methuen, Miami, Miami Lakes, Modesto, North Charleston, Palm Springs, Raleigh, Redding, San Diego, Sugar Land, Sunrise, Walnut Creek, and Winston-Salem, United StatesSee the 25 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07747103, who can take part
Where in United States
- Paradigm Clinical Research Centers, LLCAurora, United StatesContact: Site CoordinatorNot yet recruiting
- Paradigm Clinical Research Centers, LLCBoise, United StatesContact: Site CoordinatorNot yet recruiting
- Boston Clinical TrialsBoston, United StatesContact: Site CoordinatorNot yet recruiting
- M3 Wake ResearchCharleston, United StatesContact: Site CoordinatorNot yet recruiting
- Charlotteville Medical Research Center, LLCCharlottesville, United StatesContact: Site CoordinatorNot yet recruiting
- M3 Wake ResearchChattanooga, United StatesContact: Site CoordinatorNot yet recruiting
- M3 Wake ResearchDallas, United StatesContact: Site CoordinatorNot yet recruiting
- Advanced Medical Trials, LLCGeorgetown, United StatesContact: Site CoordinatorNot yet recruiting
- Accel ResearchLakeland, United StatesContact: Site CoordinatorNot yet recruiting
- Accel ResearchLargo, United StatesContact: Site CoordinatorNot yet recruiting
- M3 Wake Research - Las Vegas Wellness WayLas Vegas, United StatesContact: Site CoordinatorNot yet recruiting
- ActivMed Practices and ResearchMethuen, United StatesContact: Site CoordinatorNot yet recruiting
- Advanced Medical Research Institute, LLCMiami, United StatesContact: Site CoordinatorTaking people
- AppleMed Research Group, LLCMiami, United StatesContact: Site CoordinatorTaking people
- 3Sync LLCMiami Lakes, United StatesContact: Site CoordinatorNot yet recruiting
- Paradigm Clinical Research Centers, LLCModesto, United StatesContact: Site CoordinatorNot yet recruiting
- Coastal Carolina Research Center, LLCNorth Charleston, United StatesContact: Site CoordinatorNot yet recruiting
- 3Sync ResearchPalm Springs, United StatesContact: Site CoordinatorNot yet recruiting
- M3 Wake ResearchRaleigh, United StatesContact: Site CoordinatorNot yet recruiting
- Paradigm Clinical Research Centers, LLCRedding, United StatesContact: Site CoordinatorNot yet recruiting
- Paradigm Clinical Research Centers, LLCSan Diego, United StatesContact: Site CoordinatorNot yet recruiting
- Olympus Clinical ResearchSugar Land, United StatesContact: Site CoordinatorNot yet recruiting
- Precision Clinical ResearchSunrise, United StatesContact: Site CoordinatorNot yet recruiting
- Sunwise Clinical ResearchWalnut Creek, United StatesContact: Site CoordinatorNot yet recruiting
- Progressive Medicine of the Triad, LLCWinston-Salem, United StatesContact: Site CoordinatorNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Neuvosyn Laboratories, LLC
- Trial code
- NCT07747103
- Record updated
- 5 August 2026
- Original 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.Read full original descriptionShow less
An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets for the Treatment of Primary Hypothyroidism
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.
Inclusion: 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: 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; 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; Have uncontrolled diabetes; For female subjects, be pregnant, nursing or planning to become pregnant during the study.