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

Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345339
• Other study ID #: M21-341
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 26, 2024
• Est. completion date: June 3, 2028

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2800
• Est. completion date: June 3, 2028
• Est. primary completion date: June 3, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Have a diagnosis of primary hypothyroidism made >= 12 months prior to Screening.
• Be on continuous thyroid replacement therapy with an FDA-approved dose of synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit.
• Be on a stable FDA-approved daily dose of synthetic T4 prior to the Screening visit, and must be taking synthetic T4 dose of at least 25 mcg at Screening visit. Must enter the study using the same stable dose to determine dose conversion.
• Documentation of 1 in-range thyroid-stimulating hormone (TSH) (i.e., within 0.45 - 4.12 mIU/L, inclusive) at Screening and at least 1 additional in range TSH taken at a minimum of 6 weeks and a maximum of 12 months prior to Screening.

Exclusion Criteria:

• Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of Armour Thyroid or synthetic T4.
• History of alcohol or other substance abuse within the previous 2 years prior to the Screening.
• Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, synthetic T4, other thyroid replacement medications, or pork products.

Related Conditions & MeSH terms

• Hypothyroidism
• Thyroid Diseases

Intervention

Drug:
• Armour Thyroid
Oral Capsule or Tablet
• Levothyroxine
Oral Capsule

Locations

Country	Name	City	State
United States	Texas Diabetes and Endocrinology - Central Austin /ID# 255728	Austin	Texas
United States	Texas Diabetes and Endocrinology - South Austin /ID# 255723	Austin	Texas
United States	Diabetes and Endocrinology Associates of Stark County Inc /ID# 256751	Canton	Ohio
United States	West Broadway Clinic /ID# 256756	Council Bluffs	Iowa
United States	North TX Endocrine Center /ID# 255737	Dallas	Texas
United States	Academy of Diabetes, Thyroid and Endocrine /ID# 255735	El Paso	Texas
United States	Diagnamics Inc. /ID# 262680	Encinitas	California
United States	NECCR PrimaCare Research, LLC /ID# 256531	Fall River	Massachusetts
United States	Diabetes and Thyroid Center of Ft. Worth /ID# 256781	Fort Worth	Texas
United States	NorCal Medical Research /ID# 256512	Greenbrae	California
United States	Physician's East Endocrinology /ID# 256491	Greenville	North Carolina
United States	Biopharma Informatic - Houston - Business Center Drive /ID# 256149	Houston	Texas
United States	Juno Research /ID# 259238	Houston	Texas
United States	L-MARC Research Center /ID# 255733	Louisville	Kentucky
United States	South Florida Wellness & Clinic /ID# 256513	Margate	Florida
United States	Southern Endocrinology Associates /ID# 256795	Mesquite	Texas
United States	Lucas Research /ID# 257061	Morehead City	North Carolina
United States	Mid State Endocrine Associates /ID# 259641	Nashville	Tennessee
United States	NYC Research /ID# 258662	New York	New York
United States	Lynn Institute of Norman /ID# 256785	Norman	Oklahoma
United States	West Orange Endocrinology /ID# 256139	Ocoee	Florida
United States	Lynn Institute of Oklahoma City /ID# 263141	Oklahoma City	Oklahoma
United States	Comprehensive Medical & Research Center /ID# 261678	Plantation	Florida
United States	Rainier Clinical Research /ID# 255802	Renton	Washington
United States	Endocrine Research Solutions /ID# 256784	Roswell	Georgia
United States	Texas Diabetes and Endocrinology /ID# 255722	Round Rock	Texas
United States	Consano Clinical Research, LLC /ID# 256138	Shavano Park	Texas
United States	Endocrine Assc Long Island PC /ID# 257357	Smithtown	New York
United States	Texas Valley Clinical Research /ID# 261476	Weslaco	Texas
United States	Metabolic Research Inst /ID# 255729	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response	TSH response is defined as TSH values falling within 0.45 to 4.12 mIU/L. 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).	Week 55
Primary	Number of Participants with Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to approximately 90 weeks
Secondary	Percentage of Participants who Achieve TSH Response	TSH response is defined as TSH values falling within 0.45 to 4.12 mIU/L. 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 [stricter than the one used in the Primary Outcome Measure]).	Week 55
Secondary	Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid	Number of participants needing altered dose conversion from synthetic T4 to Armour Thyroid.	Up to approximately 29 weeks
Secondary	Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period	Frequency of dose titrations (0,1,2...) during the DB period among participants who achieved TSH response at the end of the DB period.	Week 55

External Links

•   Related Info