A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism
NCT ID: NCT05712421
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
303 participants
INTERVENTIONAL
2023-02-28
2025-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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North Star
North Star
North Star
Levothyroxine
Levothyroxine
Levothyroxine
Interventions
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North Star
North Star
Levothyroxine
Levothyroxine
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Neuvosyn Laboratories, LLC
INDUSTRY
Responsible Party
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Locations
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Neuvosyn Investigational Site
Birmingham, Alabama, United States
Neuvosyn Investigational Site
Canoga Park, California, United States
Neuvosyn Investigational Site
Greenbrae, California, United States
Neuvosyn Investigational Site
Toluca Lake, California, United States
Neuvosyn Investigational Site
Farmington, Connecticut, United States
Neuvosyn Investigational Site
Boca Raton, Florida, United States
Neuvosyn Investigational Site
Miami, Florida, United States
Neuvosyn Investigational Site
Miami, Florida, United States
Neuvosyn Investigational Site
Miami, Florida, United States
Neuvosyn Investigational Site
Miami, Florida, United States
Neuvosyn Investigational Site
Miami, Florida, United States
Neuvosyn Investigational Site
Sunrise, Florida, United States
Neuvosyn Investigational Site
Acworth, Georgia, United States
Neuvosyn Investigational Site
Atlanta, Georgia, United States
Neuvosyn Investigational Site
Columbus, Georgia, United States
Neuvosyn Investigational Site
Sugar Hill, Georgia, United States
Neuvosyn Investigational Site
Saginaw, Michigan, United States
Neuvosyn Investigational Site
Gladstone, Missouri, United States
Neuvosyn Investigational Site
Williamsville, New York, United States
Neuvosyn Investigational Site
Denver, North Carolina, United States
Neuvosyn Investigational Site
Winston-Salem, North Carolina, United States
Neuvosyn Investigational Site
Beavercreek, Ohio, United States
Neuvosyn Investigational Site
Columbus, Ohio, United States
Neuvosyn Investigational Site
Georgetown, Texas, United States
Neuvosyn Investigational Site
Houston, Texas, United States
Neuvosyn Investigational Site
Katy, Texas, United States
Neuvosyn Investigational Site
Katy, Texas, United States
Neuvosyn Investigational Site
Lewisville, Texas, United States
Neuvosyn Investigational Site
Paris, Texas, United States
Neuvosyn Investigational Site
Pearland, Texas, United States
Neuvosyn Investigational Site
Stafford, Texas, United States
Countries
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Other Identifiers
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NorthStar-02-001
Identifier Type: -
Identifier Source: org_study_id
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