HypothyroidismPhase 2NCT05712421
A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism
A Phase 2 study testing North Star and Levothyroxine in people with Hypothyroidism, run by Neuvosyn Laboratories, LLC at 31 sites in United States.
Trial summary
The North Star study is a multi-center, Phase 2, double-blind, randomized, parallel group clinical study to evaluate the safe and effective dose conversion from Levothyroxine to 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?
- North Star and Levothyroxine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 31 sitesUnited States
- Study dates
- 28 Feb 2023to 18 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- On continuous thyroid replacement therapy for at least 6 months before Study Entry
- On a stable daily dose of LT4 for a minimum of 12 weeks prior to Screening
- 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 or levothyroxine
- Hospitalization for a major illness within 4 weeks prior to Screening
- Anticipated initiation or change in concomitant medications
- Concomitant use of prohibited medications or supplements
- 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
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Neuvosyn Investigational Site
Acworth, Georgia, 30101
Neuvosyn Investigational Site
Atlanta, Georgia, 30318
Neuvosyn Investigational Site
Beavercreek, Ohio, 45440
Neuvosyn Investigational Site
Birmingham, Alabama, 35209
Neuvosyn Investigational Site
Boca Raton, Florida, 33434
Neuvosyn Investigational Site
Canoga Park, California, 91304
Neuvosyn Investigational Site
Columbus, Georgia, 31904
Neuvosyn Investigational Site
Columbus, Ohio, 31904
Neuvosyn Investigational Site
Denver, North Carolina, 28037
Neuvosyn Investigational Site
Farmington, Connecticut, 06030
Neuvosyn Investigational Site
Georgetown, Texas, 78628
Neuvosyn Investigational Site
Gladstone, Missouri, 64118
Neuvosyn Investigational Site
Greenbrae, California, 94904
Neuvosyn Investigational Site
Houston, Texas, 77040
Neuvosyn Investigational Site
Katy, Texas, 77450
Neuvosyn Investigational Site
Katy, Texas, 77494
Neuvosyn Investigational Site
Lewisville, Texas, 75067
Neuvosyn Investigational Site
Miami, Florida, 33144
Neuvosyn Investigational Site
Miami, Florida, 33145
Neuvosyn Investigational Site
Miami, Florida, 33155
Neuvosyn Investigational Site
Miami, Florida, 33174
Neuvosyn Investigational Site
Miami, Florida, 33179
Neuvosyn Investigational Site
Paris, Texas, 75462
Neuvosyn Investigational Site
Pearland, Texas, 77584
Neuvosyn Investigational Site
Saginaw, Michigan, 48602
Neuvosyn Investigational Site
Stafford, Texas, 77477
Neuvosyn Investigational Site
Sugar Hill, Georgia, 30024
Neuvosyn Investigational Site
Sunrise, Florida, 33351
Neuvosyn Investigational Site
Toluca Lake, California, 91602
Neuvosyn Investigational Site
Williamsville, New York, 14221
Neuvosyn Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-blind, Dose-Conversion Study to Evaluate the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Subjects With Primary Hypothyroidism Who Are Euthyroid on Levothyroxine Replacement Therapy
The North Star study is a multi-center, Phase 2, double-blind, randomized, parallel group clinical study to evaluate the safe and effective dose conversion from Levothyroxine to North Star therapy.
- Conditions
- Hypothyroidism
- Being tested
- North Star, Levothyroxine
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
North StarDrug
North Star
LevothyroxineDrug
Levothyroxine
| Study group | Role | What they receive |
|---|---|---|
| North Star | Experimental | Not described Receives: Drug: North Star |
| Levothyroxine | Active comparator | Not described Receives: Drug: Levothyroxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of the LT4 dose (mcg/day) at screening to North Star (mg/day) at the end of the treatment period required to achieve and maintain serum thyroid-stimulating hormone (TSH) levels within the normal reference range.
Measured: Week 30
Secondary outcomes (1)
Proportion of subjects who are euthyroid as determined by serum TSH level within the normal reference range at the end of the treatment period.
Measured: Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start28 Feb 2023
- Primary completion5 May 2025
- Study completion18 Sep 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuvosyn Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712421
- Sponsor's protocol ID
- NorthStar-02-001
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Dose-Conversion Study to Evaluate the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Subjects With Primary Hypothyroidism Who Are Euthyroid on Levothyroxine Replacement Therapy
- ClinicalTrials.gov ID
- NCT05712421
- Acronym / sponsor ID
- NorthStar-02-001
- Conditions
- Hypothyroidism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Neuvosyn Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 3 Feb 2023 (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 2, double-blind, randomized, parallel group clinical study to evaluate the safe and effective dose conversion from Levothyroxine to North Star therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| North Star | Experimental | Drug: North Star |
| Levothyroxine | Active comparator | Drug: Levothyroxine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with primary hypothyroidism
- On continuous thyroid replacement therapy for at least 6 months before Study Entry
- On a stable daily dose of LT4 for a minimum of 12 weeks prior to Screening
- Agree to practice a method of contraception
- Female patients not pregnant or lactating at Screening
Key exclusion criteria (6 listed)
- Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of North Star or levothyroxine
- Hospitalization for a major illness within 4 weeks prior to Screening
- Anticipated initiation or change in concomitant medications
- Concomitant use of prohibited medications or supplements
- 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.
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 |
|---|---|---|
| North StarNorth Star | Drug | North Star |
| LevothyroxineLevothyroxine | Drug | Levothyroxine |
Primary outcome
The ratio of the LT4 dose (mcg/day) at screening to North Star (mg/day) at the end of the treatment period required to achieve and maintain serum thyroid-stimulating hormone (TSH) levels within the normal reference range.
Time frame: Week 30
1 secondary outcome
Proportion of subjects who are euthyroid as determined by serum TSH level within the normal reference range at the end of the treatment period.
Time frame: Week 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing North Star and Levothyroxine in people with Hypothyroidism, run by Neuvosyn Laboratories, LLC at 31 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of the LT4 dose (mcg/day) at screening to North Star (mg/day) at the end of the treatment period required to achieve and maintain serum thyroid-stimulating hormone (TSH) levels within the normal reference range. (time frame: Week 30). 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 18 Feb 2026.