A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism
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
1 other identifier
interventional
303
1 country
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2023
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2023
CompletedFirst Posted
Study publicly available on registry
February 3, 2023
CompletedStudy Start
First participant enrolled
February 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2025
CompletedFebruary 18, 2026
February 1, 2026
2.2 years
January 18, 2023
February 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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.
Week 30
Study Arms (2)
North Star
EXPERIMENTALLevothyroxine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Neuvosyn Investigational Site
Birmingham, Alabama, 35209, United States
Neuvosyn Investigational Site
Canoga Park, California, 91304, United States
Neuvosyn Investigational Site
Greenbrae, California, 94904, United States
Neuvosyn Investigational Site
Toluca Lake, California, 91602, United States
Neuvosyn Investigational Site
Farmington, Connecticut, 06030, United States
Neuvosyn Investigational Site
Boca Raton, Florida, 33434, United States
Neuvosyn Investigational Site
Miami, Florida, 33144, United States
Neuvosyn Investigational Site
Miami, Florida, 33145, United States
Neuvosyn Investigational Site
Miami, Florida, 33155, United States
Neuvosyn Investigational Site
Miami, Florida, 33174, United States
Neuvosyn Investigational Site
Miami, Florida, 33179, United States
Neuvosyn Investigational Site
Sunrise, Florida, 33351, United States
Neuvosyn Investigational Site
Acworth, Georgia, 30101, United States
Neuvosyn Investigational Site
Atlanta, Georgia, 30318, United States
Neuvosyn Investigational Site
Columbus, Georgia, 31904, United States
Neuvosyn Investigational Site
Sugar Hill, Georgia, 30024, United States
Neuvosyn Investigational Site
Saginaw, Michigan, 48602, United States
Neuvosyn Investigational Site
Gladstone, Missouri, 64118, United States
Neuvosyn Investigational Site
Williamsville, New York, 14221, United States
Neuvosyn Investigational Site
Denver, North Carolina, 28037, United States
Neuvosyn Investigational Site
Winston-Salem, North Carolina, 27103, United States
Neuvosyn Investigational Site
Beavercreek, Ohio, 45440, United States
Neuvosyn Investigational Site
Columbus, Ohio, 31904, United States
Neuvosyn Investigational Site
Georgetown, Texas, 78628, United States
Neuvosyn Investigational Site
Houston, Texas, 77040, United States
Neuvosyn Investigational Site
Katy, Texas, 77450, United States
Neuvosyn Investigational Site
Katy, Texas, 77494, United States
Neuvosyn Investigational Site
Lewisville, Texas, 75067, United States
Neuvosyn Investigational Site
Paris, Texas, 75462, United States
Neuvosyn Investigational Site
Pearland, Texas, 77584, United States
Neuvosyn Investigational Site
Stafford, Texas, 77477, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2023
First Posted
February 3, 2023
Study Start
February 28, 2023
Primary Completion
May 5, 2025
Study Completion
September 18, 2025
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share