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

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neuvosyn Laboratories, LLC

Criteria

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