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

Phase 2

Active, not recruiting

• Conditions: Hypothyroidism
• Interventions: Drug: Levothyroxine; Drug: North Star

• Registration Number: NCT05712421
• Lead Sponsor: Neuvosyn Laboratories, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-02-03
• Study Start: 2023-02-28
• Status Verified: 2025-05
• Primary Completion: 2025-05-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Study Completion: 2025-12-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levothyroxine	Levothyroxine	-
North Star	North Star	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Neuvosyn Investigational Site; 🇺🇸 Stafford, Texas, United States