A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism

NCT05712421
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Completed
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Participants
303
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Lead sponsor
Neuvosyn Laboratories, LLC
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Start date
2023-02-28
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Number of sites
31
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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.
clinicaltrials.gov
Short title
A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism
clinicaltrials.gov
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-09-18
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First posted
2023-02-03
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Registry last updated
2026-02-18
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Primary completion date
2025-05-05
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Start date
2023-02-28
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Actual participants
303
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Participants
303
clinicaltrials.gov
Participant count basis
Actual
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Protocol amendments
1
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Number of sites
31
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Registry sponsor category
Industry
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Lead sponsor
Neuvosyn Laboratories, LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05712421
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05712421
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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.

    Timeframe: Week 30

  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.

    Timeframe: Week 30

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Neuvosyn Investigational SiteBirmingham, United States
  • Neuvosyn Investigational SiteCanoga Park, United States
  • Neuvosyn Investigational SiteGreenbrae, United States
  • Neuvosyn Investigational SiteToluca Lake, United States
  • Neuvosyn Investigational SiteFarmington, United States
  • Neuvosyn Investigational SiteBoca Raton, United States
  • Neuvosyn Investigational SiteMiami, United States
  • Neuvosyn Investigational SiteMiami, United States
  • Neuvosyn Investigational SiteMiami, United States
  • Neuvosyn Investigational SiteMiami, United States
  • Neuvosyn Investigational SiteMiami, United States
  • Neuvosyn Investigational SiteSunrise, United States
  • Neuvosyn Investigational SiteAcworth, United States
  • Neuvosyn Investigational SiteAtlanta, United States
  • Neuvosyn Investigational SiteColumbus, United States
  • Neuvosyn Investigational SiteSugar Hill, United States
  • Neuvosyn Investigational SiteSaginaw, United States
  • Neuvosyn Investigational SiteGladstone, United States
  • Neuvosyn Investigational SiteWilliamsville, United States
  • Neuvosyn Investigational SiteDenver, United States
  • Neuvosyn Investigational SiteWinston-Salem, United States
  • Neuvosyn Investigational SiteBeavercreek, United States
  • Neuvosyn Investigational SiteColumbus, United States
  • Neuvosyn Investigational SiteGeorgetown, United States
  • Neuvosyn Investigational SiteHouston, United States

And 6 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (2)