An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.

July 30, 2026 updated by: Neuvosyn Laboratories, LLC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

466

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Modesto, California, United States, 95355
        • Not yet recruiting
        • Paradigm Clinical Research Centers, LLC
        • Contact:
          • Site Coordinator
          • Phone Number: 209-554-4844
      • Redding, California, United States, 96001
        • Not yet recruiting
        • Paradigm Clinical Research Centers, LLC
        • Contact:
          • Site Coordinator
          • Phone Number: 530-247-7049
      • San Diego, California, United States, 92108
        • Not yet recruiting
        • Paradigm Clinical Research Centers, LLC
        • Contact:
          • Site Coordinator
          • Phone Number: 858-274-4226
      • Walnut Creek, California, United States, 94596
        • Not yet recruiting
        • Sunwise Clinical Research
        • Contact:
          • Site Coordinator
          • Phone Number: 925-298-5147
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Not yet recruiting
        • Paradigm Clinical Research Centers, LLC
        • Contact:
          • Site Coordinator
          • Phone Number: 303-219-1830
    • Florida
      • Lakeland, Florida, United States, 33803
        • Not yet recruiting
        • Accel Research
        • Contact:
          • Site Coordinator
          • Phone Number: 863-940-2087
      • Largo, Florida, United States, 33777
        • Not yet recruiting
        • Accel Research
        • Contact:
          • Site Coordinator
          • Phone Number: 727-346-8839
      • Miami, Florida, United States, 33126
        • Recruiting
        • AppleMed Research Group, LLC
        • Contact:
          • Site Coordinator
          • Phone Number: 305-667-8434
      • Miami, Florida, United States, 33147
        • Recruiting
        • Advanced Medical Research Institute, LLC
        • Contact:
          • Site Coordinator
          • Phone Number: 786-558-7300
      • Miami Lakes, Florida, United States, 33014
        • Not yet recruiting
        • 3Sync LLC
        • Contact:
          • Site Coordinator
          • Phone Number: 786-850-8553
      • Palm Springs, Florida, United States, 33461
        • Not yet recruiting
        • 3Sync Research
        • Contact:
          • Site Coordinator
          • Phone Number: 561-910-5792
      • Sunrise, Florida, United States, 33351
        • Not yet recruiting
        • Precision Clinical Research
        • Contact:
          • Site Coordinator
          • Phone Number: 954-915-9991
    • Idaho
      • Boise, Idaho, United States, 83709
        • Not yet recruiting
        • Paradigm Clinical Research Centers, LLC
        • Contact:
          • Site Coordinator
          • Phone Number: 208-801-7438
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Not yet recruiting
        • Boston Clinical Trials
        • Contact:
          • Site Coordinator
          • Phone Number: 617-477-4868
      • Methuen, Massachusetts, United States, 01844
        • Not yet recruiting
        • ActivMed Practices and Research
        • Contact:
          • Site Coordinator
          • Phone Number: 978-655-7155
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Not yet recruiting
        • M3 Wake Research - Las Vegas Wellness Way
        • Contact:
          • Site Coordinator
          • Phone Number: 702-893-8968
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Not yet recruiting
        • M3 Wake Research
        • Contact:
          • Site Coordinator
          • Phone Number: 919-781-2514
      • Winston-Salem, North Carolina, United States, 27103
        • Not yet recruiting
        • Progressive Medicine of the Triad, LLC
        • Contact:
          • Site Coordinator
          • Phone Number: 336-768-3456
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Not yet recruiting
        • M3 Wake Research
        • Contact:
          • Site Coordinator
          • Phone Number: 843-258-1852
      • North Charleston, South Carolina, United States, 29405
        • Not yet recruiting
        • Coastal Carolina Research Center, LLC
        • Contact:
          • Site Coordinator
          • Phone Number: 7035 843-856-3784
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Not yet recruiting
        • M3 Wake Research
        • Contact:
          • Site Coordinator
          • Phone Number: 423-698-4584
    • Texas
      • Dallas, Texas, United States, 75246
        • Not yet recruiting
        • M3 Wake Research
        • Contact:
          • Site Coordinator
          • Phone Number: 469-297-3074
      • Georgetown, Texas, United States, 78628
        • Not yet recruiting
        • Advanced Medical Trials, LLC
        • Contact:
          • Site Coordinator
          • Phone Number: 306 512-868-0901
      • Sugar Land, Texas, United States, 77478
        • Not yet recruiting
        • Olympus Clinical Research
        • Contact:
          • Site Coordinator
          • Phone Number: 346-397-4457
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Not yet recruiting
        • Charlotteville Medical Research Center, LLC
        • Contact:
          • Site Coordinator
          • Phone Number: 434-817-2442

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: North Star
North Star Desiccated Porcine Thyroid Extract Tablets
Drug: Desiccated Porcine Thyroid Extract Tablets
North Star

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuvosyn Laboratories, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 17, 2026

First Submitted That Met QC Criteria

July 30, 2026

First Posted (Actual)

August 5, 2026

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NorthStar003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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