Clinical trial NCT05712421: A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hypothyroidism
Lead sponsor: Neuvosyn Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2023-02-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Neuvosyn Investigational Site
state: Alabama
city: Canoga Park
country: United States
facility: Neuvosyn Investigational Site
state: California
city: Greenbrae
country: United States
facility: Neuvosyn Investigational Site
state: California
city: Toluca Lake
country: United States
facility: Neuvosyn Investigational Site
state: California
city: Farmington
country: United States
facility: Neuvosyn Investigational Site
state: Connecticut
city: Boca Raton
country: United States
facility: Neuvosyn Investigational Site
state: Florida
city: Miami
country: United States
facility: Neuvosyn Investigational Site
state: Florida
city: Miami
country: United States
facility: Neuvosyn Investigational Site
state: Florida
city: Miami
country: United States
facility: Neuvosyn Investigational Site
state: Florida
city: Miami
country: United States
facility: Neuvosyn Investigational Site
state: Florida
city: Miami
country: United States
facility: Neuvosyn Investigational Site
state: Florida
city: Sunrise
country: United States
facility: Neuvosyn Investigational Site
state: Florida
city: Acworth
country: United States
facility: Neuvosyn Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Neuvosyn Investigational Site
state: Georgia
city: Columbus
country: United States
facility: Neuvosyn Investigational Site
state: Georgia
city: Sugar Hill
country: United States
facility: Neuvosyn Investigational Site
state: Georgia
city: Saginaw
country: United States
facility: Neuvosyn Investigational Site
state: Michigan
city: Gladstone
country: United States
facility: Neuvosyn Investigational Site
state: Missouri
city: Williamsville
country: United States
facility: Neuvosyn Investigational Site
state: New York
city: Denver
country: United States
facility: Neuvosyn Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Neuvosyn Investigational Site
state: North Carolina
city: Beavercreek
country: United States
facility: Neuvosyn Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Neuvosyn Investigational Site
state: Ohio
city: Georgetown
country: United States
facility: Neuvosyn Investigational Site
state: Texas
city: Houston
country: United States
facility: Neuvosyn Investigational Site
state: Texas
city: Katy
country: United States
facility: Neuvosyn Investigational Site
state: Texas
city: Katy
country: United States
facility: Neuvosyn Investigational Site
state: Texas
city: Lewisville
country: United States
facility: Neuvosyn Investigational Site
state: Texas
city: Paris
country: United States
facility: Neuvosyn Investigational Site
state: Texas
city: Pearland
country: United States
facility: Neuvosyn Investigational Site
state: Texas
city: Stafford
country: United States
facility: Neuvosyn Investigational Site
state: Texas
Study officials:
References: