NCT05712421

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Neuvosyn Laboratories, LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypothyroidism

Interventions

Type	Name	Description
DRUG	North Star	North Star
DRUG	Levothyroxine	Levothyroxine

Timeline

• Start date: 2023-02-28
• Primary completion: 2025-05-05
• Completion: 2025-09-18
• First posted: 2023-02-03
• Last updated: 2026-02-18

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study