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

A Phase 2/3 Multicenter, Double Blinded, Randomized, Dose-conversion, Active Control Study Examining the Efficacy and Safety of Armour Thyroid Compared to Synthetic T4 for the Treatment of Adults With Primary Hypothyroidism

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2,800 (estimated)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypothyroidism

Interventions

Type	Name	Description
DRUG	Armour Thyroid	Oral Capsule or Tablet
DRUG	Levothyroxine	Oral Capsule

Timeline

• Start date: 2024-04-26
• Primary completion: 2027-09-01
• Completion: 2028-06-01
• First posted: 2024-04-03
• Last updated: 2026-01-05

Locations

139 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study