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OpenTrials
Completed

NCT Number: NCT05712421

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

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.

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Key information

Conditions

Hypothyroidism Endocrine System Diseases Thyroid Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neuvosyn Investigational Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

North Star

Drug

North Star

Levothyroxine

Drug

Levothyroxine

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.

    Time frame: 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.

    Time frame: Week 30

Sponsors and collaborators

Lead sponsor

Neuvosyn Laboratories, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2023
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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