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NCT06345339 · ClinicalTrials.gov registry record · Phase 2
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 study of Hypothyroidism, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 2,800
- Enrollment target
- 20
- Study locations
NCT06345339: Recruiting Phase 2 study of Hypothyroidism, sponsored by AbbVie.
NCT06345339 is a Phase 2 study of Hypothyroidism that is actively recruiting participants, run by AbbVie. The registered enrollment target is 2,800 participants, above the 518-participant average among 9 other Hypothyroidism trials with a reported enrollment target (441% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06345339, a Phase 2 study of Hypothyroidism, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 2,800 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
TSH response is defined as TSH values falling within 0.45 to 4.12 mIU/L (inclusive). TSH response will be determined at Week 55 and at a prior visit with no out-of-range TSH values in between (response rate is tested against a specified non-inferiority margin).
Conditions Studied
Interventions
- DRUG Armour Thyroid
- DRUG Levothyroxine
Study Locations (20)
California
- Kaiser San Diego Dept Endocrinology, SCPMG /ID# 262552 - Bonita
- Facey Medical Foundation - Burbank /ID# 262104 - Burbank
- John Muir Medical Center /ID# 257103 - Concord
- Diagnamics Inc. /ID# 262680 - Encinitas
- Providence - St. Jude Medical Center /ID# 256520 - Fullerton
- NorCal Medical Research /ID# 256512 - Greenbrae
- Velocity Clinical Research - Huntington Park /ID# 259044 - Huntington Park
- Scripps Whittier Diabetes Institute /ID# 259215 - La Jolla
- Facey Medical Foundation /ID# 260863 - Mission Hills
- Hoag Memorial Hospital Presbyterian /ID# 260990 - Newport Beach
- Diabetes Associates Medical Group /ID# 256949 - Orange
- Western University of Health Sciences /ID# 262183 - Pomona
- Research at Mills-Peninsula Medical Center - Sutter Health /ID# 258825 - San Mateo
- Care Access - Santa Clarita /ID# 262573 - Santa Clarita
- Facey Medical Foundation - Valencia /ID# 262102 - Santa Clarita
- Olive View UCLA Medical Center /ID# 259092 - Sylmar
- The Lundquist Institute at Harbor-UCLA Medical Center /ID# 262572 - Torrance
- Diablo Clinical Research /ID# 261329 - Walnut Creek
Alabama
- Central Research Associates /ID# 255719 - Birmingham
- UAB Hospital /ID# 262565 - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,800 participants |
| Start Date | 2024-04-26 |
| Est. Completion | 2028-06 |
| Phase | Phase 2 |
What NCT06345339 shows while recruiting
NCT06345339 is an interventional study that assigns participants to a tested intervention. Its 2,800 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9 other Hypothyroidism trials with a reported enrollment target (441% higher).
The record links to 1 condition, with Hypothyroidism appearing as the primary indexed condition, and to 2 interventions - of which Armour Thyroid is the first listed.
NCT06345339 names 20 study sites across 2 states, led by California, Alabama.
Frequently Asked Questions
What is clinical trial NCT06345339 about?
NCT06345339 is a clinical study titled "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". 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...
What is the current status of trial NCT06345339?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 2,800 participants. The study started on 2024-04-26. Estimated completion is 2028-06.
What conditions does trial NCT06345339 study?
This clinical trial studies the following conditions: Hypothyroidism.
What interventions are being tested in trial NCT06345339?
The interventions under investigation include: Armour Thyroid (DRUG), Levothyroxine (DRUG).
Who is sponsoring clinical trial NCT06345339?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06345339 being conducted?
This trial has 20 study locations across Alabama, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypothyroidism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06345339's enrollment target sits among peer trials
2,800 1st of 9 higher than 9 of 9 other Hypothyroidism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypothyroidism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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