HypothyroidismPhase 3NCT07747103
An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.
A Phase 3 study testing Desiccated Porcine Thyroid Extract Tablets in people with Hypothyroidism, run by Neuvosyn Laboratories, LLC at 25 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Desiccated Porcine Thyroid Extract Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 25 sitesUnited States
- Study dates
- 30 Jun 2026to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
United States25 sites, 25 recruiting
- Not yet recruiting
Paradigm Clinical Research Centers, LLC
Aurora, Colorado, 80012
Site Coordinator, 303-219-1830
- Not yet recruiting
Paradigm Clinical Research Centers, LLC
Boise, Idaho, 83709
Site Coordinator, 208-801-7438
- Not yet recruiting
Boston Clinical Trials
Boston, Massachusetts, 02131
Site Coordinator, 617-477-4868
- Not yet recruiting
M3 Wake Research
Charleston, South Carolina, 29414
Site Coordinator, 843-258-1852
- Not yet recruiting
Charlotteville Medical Research Center, LLC
Charlottesville, Virginia, 22911
Site Coordinator, 434-817-2442
- Not yet recruiting
M3 Wake Research
Chattanooga, Tennessee, 37421
Site Coordinator, 423-698-4584
- Not yet recruiting
M3 Wake Research
Dallas, Texas, 75246
Site Coordinator, 469-297-3074
- Not yet recruiting
Advanced Medical Trials, LLC
Georgetown, Texas, 78628
Site Coordinator, 512-868-0901 ext. 306
- Not yet recruiting
Accel Research
Lakeland, Florida, 33803
Site Coordinator, 863-940-2087
- Not yet recruiting
Accel Research
Largo, Florida, 33777
Site Coordinator, 727-346-8839
- Not yet recruiting
M3 Wake Research - Las Vegas Wellness Way
Las Vegas, Nevada, 89106
Site Coordinator, 702-893-8968
- Not yet recruiting
ActivMed Practices and Research
Methuen, Massachusetts, 01844
Site Coordinator, 978-655-7155
- Recruiting
AppleMed Research Group, LLC
Miami, Florida, 33126
Site Coordinator, 305-667-8434
- Recruiting
Advanced Medical Research Institute, LLC
Miami, Florida, 33147
Site Coordinator, 786-558-7300
- Not yet recruiting
3Sync LLC
Miami Lakes, Florida, 33014
Site Coordinator, 786-850-8553
- Not yet recruiting
Paradigm Clinical Research Centers, LLC
Modesto, California, 95355
Site Coordinator, 209-554-4844
- Not yet recruiting
Coastal Carolina Research Center, LLC
North Charleston, South Carolina, 29405
Site Coordinator, 843-856-3784 ext. 7035
- Not yet recruiting
3Sync Research
Palm Springs, Florida, 33461
Site Coordinator, 561-910-5792
- Not yet recruiting
M3 Wake Research
Raleigh, North Carolina, 27612
Site Coordinator, 919-781-2514
- Not yet recruiting
Paradigm Clinical Research Centers, LLC
Redding, California, 96001
Site Coordinator, 530-247-7049
- Not yet recruiting
Paradigm Clinical Research Centers, LLC
San Diego, California, 92108
Site Coordinator, 858-274-4226
- Not yet recruiting
Olympus Clinical Research
Sugar Land, Texas, 77478
Site Coordinator, 346-397-4457
- Not yet recruiting
Precision Clinical Research
Sunrise, Florida, 33351
Site Coordinator, 954-915-9991
- Not yet recruiting
Sunwise Clinical Research
Walnut Creek, California, 94596
Site Coordinator, 925-298-5147
- Not yet recruiting
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, 27103
Site Coordinator, 336-768-3456
About this study
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
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 the detailed description
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
- Conditions
- Hypothyroidism
- Being tested
- Desiccated Porcine Thyroid Extract Tablets
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desiccated Porcine Thyroid Extract TabletsDrug
North Star
| Study group | Role | What they receive |
|---|---|---|
| North Star | Experimental | North Star Desiccated Porcine Thyroid Extract Tablets Receives: Drug: Desiccated Porcine Thyroid Extract Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (1)
Collection and review of adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions, adverse events of special interest, clinical laboratory evaluations, 12-lead ECG, and physical examination.
Safety will be evaluated by tracking the frequency, severity, and relationship of adverse events to the study drug from the first dose through the end of the follow-up period. The number and percentage of participants experiencing any treatment-emergent adverse event (TEAE) will be summarized by system organ class and preferred term. In addition, SAEs and TEAEs leading to withdrawal from the study will be summarized. Observed values and change from Baseline values in vital signs (body temperature, systolic and diastolic blood pressure, pulse, and respiratory rate), ECG parameters for QT interval evaluation, clinical laboratory parameters (hematology, serum chemistry, urinalysis) and physical examinations (to include general al appearance, head, eyes, ears, nose, throat, neck, cardiovascular, lungs, abdominal, extremities, neurologic, skin, lymph nodes, and musculoskeletal system) will be summarized by time point. All safety analyses will be based on the safety population.
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start30 Jun 2026
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuvosyn Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747103
- Sponsor's protocol ID
- NorthStar003
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07747103
- Acronym / sponsor ID
- NorthStar003
- Conditions
- Hypothyroidism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- Neuvosyn Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| North Star | Experimental | Drug: Desiccated Porcine Thyroid Extract TabletsNorth Star Desiccated Porcine Thyroid Extract Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desiccated Porcine Thyroid Extract TabletsNorth Star | Drug | North Star |
Primary outcome
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
1 secondary outcome
Collection and review of adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions, adverse events of special interest, clinical laboratory evaluations, 12-lead ECG, and physical examination.
Time frame: 30 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desiccated Porcine Thyroid Extract Tablets in people with Hypothyroidism, run by Neuvosyn Laboratories, LLC at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.