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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypothyroidism

Intervention / Treatment
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* Drug: North Star
* Drug: Levothyroxine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: North Star<br> | Drug: North Star<br>* North Star<br>|
| Active Comparator: Levothyroxine<br> | Drug: Levothyroxine<br>* Levothyroxine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |