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NCT05712421 Clinical Trial

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

Hypothyroidism Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05712421
Other study ID # NorthStar-02-001
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date February 28, 2023
Est. completion date November 2024

Study information
Verified date May 2023
Source Neuvosyn Laboratories, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 300
Est. completion date November 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• North Star
North Star
• Levothyroxine
Levothyroxine

Locations
Country Name City State
United States Neuvosyn Investigational Site Acworth Georgia
United States Neuvosyn Investigational Site Atlanta Georgia
United States Neuvosyn Investigational Site Beavercreek Ohio
United States Neuvosyn Investigational Site Birmingham Alabama
United States Neuvosyn Investigational Site Boca Raton Florida
United States Neuvosyn Investigational Site Canoga Park California
United States Neuvosyn Investigational Site Columbus Georgia
United States Neuvosyn Investigational Site Columbus Ohio
United States Neuvosyn Investigational Site Denver North Carolina
United States Neuvosyn Investigational Site Georgetown Texas
United States Neuvosyn Investigational Site Gladstone Missouri
United States Neuvosyn Investigational Site Greenbrae California
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 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 Paris Texas
United States Neuvosyn Investigational Site Pearland Texas
United States Neuvosyn Investigational Site Saginaw Michigan
United States Neuvosyn Investigational Site Stafford Texas
United States Neuvosyn Investigational Site Sugar Hill Georgia
United States Neuvosyn Investigational Site Sunrise Florida
United States Neuvosyn Investigational Site Toluca Lake California
United States Neuvosyn Investigational Site Williamsville New York
United States Neuvosyn Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Neuvosyn Laboratories, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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