drugset / Trial / NCT06345339

A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants

NCT06345339

Phase 2/3 Recruiting 2800 enrolled AbbVie
RandomizedParallel-groupTriple-blindTreatment

Summary

This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[TSH\]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy.

Timeline

Start
2024-04-26
Primary completion
2027-09
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Desiccated Thyroid Extract Unknown Oral
Subject Levothyroxine Other / unclassified Oral

Indications