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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 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.

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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.

Conditions Studied

Hypothyroidism

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

FieldValue
Enrollment Target 2,800 participants
Start Date 2024-04-26
Est. Completion 2028-06
Phase Phase 2

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06345339

The ClinicalTrials.gov registry entry for NCT06345339 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 2,800 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 518-participant average among 9 other Hypothyroidism trials with a reported enrollment target (441% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.