An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.
1 other identifier
interventional
466
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2026
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2026
CompletedFirst Submitted
Initial submission to the registry
July 17, 2026
CompletedFirst Posted
Study publicly available on registry
August 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
August 5, 2026
July 1, 2026
1.3 years
July 17, 2026
July 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
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.
30 weeks
Study Arms (1)
North Star
EXPERIMENTALNorth Star Desiccated Porcine Thyroid Extract Tablets
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Paradigm Clinical Research Centers, LLC
Modesto, California, 95355, United States
Paradigm Clinical Research Centers, LLC
Redding, California, 96001, United States
Paradigm Clinical Research Centers, LLC
San Diego, California, 92108, United States
Sunwise Clinical Research
Walnut Creek, California, 94596, United States
Paradigm Clinical Research Centers, LLC
Aurora, Colorado, 80012, United States
Accel Research
Lakeland, Florida, 33803, United States
Accel Research
Largo, Florida, 33777, United States
AppleMed Research Group, LLC
Miami, Florida, 33126, United States
Advanced Medical Research Institute, LLC
Miami, Florida, 33147, United States
3Sync LLC
Miami Lakes, Florida, 33014, United States
3Sync Research
Palm Springs, Florida, 33461, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Paradigm Clinical Research Centers, LLC
Boise, Idaho, 83709, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844, United States
M3 Wake Research - Las Vegas Wellness Way
Las Vegas, Nevada, 89106, United States
M3 Wake Research
Raleigh, North Carolina, 27612, United States
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, 27103, United States
M3 Wake Research
Charleston, South Carolina, 29414, United States
Coastal Carolina Research Center, LLC
North Charleston, South Carolina, 29405, United States
M3 Wake Research
Chattanooga, Tennessee, 37421, United States
M3 Wake Research
Dallas, Texas, 75246, United States
Advanced Medical Trials, LLC
Georgetown, Texas, 78628, United States
Olympus Clinical Research
Sugar Land, Texas, 77478, United States
Charlotteville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2026
First Posted
August 5, 2026
Study Start
June 30, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
August 5, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share