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

Neuvosyn Laboratories

Status and phase

Completed

Phase 2

Conditions

Hypothyroidism

Treatments

Drug: North Star

Drug: Levothyroxine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05712421

NorthStar-02-001

Details and patient eligibility

About

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.

Enrollment

303 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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