Frontlight ResearchEarly access
Taking people in United StatesPhase 3
Desiccated porcine thyroid tablets for adults with underactive thyroid
Tests desiccated porcine thyroid extract tablets in adults with primary hypothyroidism.
Key facts
- Who runs it
- Neuvosyn Laboratories, LLC
- 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
- Trial code
- Registry title
- An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 466 people, planned
- Started
- 30 Jun 2026
- Expected to end
- Dec 2027
- Type of study
- Interventional
- Treatments tested
- Desiccated Porcine Thyroid Extract Tablets
- Record updated
- 5 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with primary hypothyroidism (an underactive thyroid), including Hashimoto's Thyroiditis, who take a stable dose of LT4. Everyone gets North Star pig thyroid extract tablets.
- Age
- 18 Years to 75 Years
- Sex
- All sexes can join.
- Disease stage
- Primary hypothyroidism, including Hashimoto's Thyroiditis. Thyroid levels must have been normal for at least 6 weeks and up to 12 months before Screening.
- Earlier treatment
- You must have taken a stable dose of LT4 (at least 50 mcg per day, 7 days per week) for at least 12 weeks before Screening.
Main reasons for not taking part
- Being pregnant, breastfeeding or planning a pregnancy during the study
- A condition or past surgery that might change how the body takes up or removes North Star
- Hospital stay for a major illness within 5 weeks before Screening
- Uncontrolled diabetes
- Weight loss medicines within 6 weeks before Screening
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
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
About the trial
What the trial wants to find out
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.
The group in the trial
- North StarTreatment being tested
North Star Desiccated Porcine Thyroid Extract Tablets
Treatment: Desiccated Porcine Thyroid Extract Tablets
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 doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Desiccated porcine thyroid tablets for adults with underactive thyroidGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT07747103, who can take part
- Record updated
- 5 August 2026