Armour Thyroid vs Synthetic T4 for Hypothyroidism

Recruiting at 142 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: AbbVie

Must be taking: Synthetic T4

Disqualifiers: Substance abuse, Allergy to pork, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 81 weeks

2800 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires participants to be on a stable dose of synthetic T4 before joining, so you will need to continue taking your current synthetic T4 medication to participate.

What data supports the effectiveness of the drug Armour Thyroid for hypothyroidism?

Some studies suggest that patients who do not respond well to levothyroxine alone may experience improved quality of life and symptom relief when using natural desiccated thyroid (NDT) like Armour Thyroid, which contains a combination of thyroid hormones. Additionally, some patients prefer combination therapies that include both T4 and T3 hormones, similar to what is found in Armour Thyroid. ^{1 2 3 4 5}

Is Armour Thyroid generally safe for humans?

Research shows that both desiccated thyroid products like Armour Thyroid and synthetic levothyroxine have similar safety profiles, with no significant difference in the stability of thyroid hormone levels over time. ^{2 6 7 8 9}

How does the drug Armour Thyroid differ from other treatments for hypothyroidism?

Armour Thyroid is unique because it is a natural desiccated thyroid (NDT) medication that contains a mix of two thyroid hormones, levothyroxine (T4) and liothyronine (T3), in a fixed ratio, unlike synthetic treatments that typically contain only T4. This combination may be preferred by some patients who do not respond well to synthetic T4 alone. ^{2 5 10 11 12}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for adults with primary hypothyroidism who have been stable on synthetic T4 therapy for at least a year. Participants must have had their thyroid condition diagnosed over 12 months ago and show consistent in-range thyroid-stimulating hormone (TSH) levels.

Inclusion Criteria

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

I was diagnosed with hypothyroidism more than a year ago.

I am taking a stable dose of synthetic thyroid hormone (T4) of at least 25 mcg daily.

Exclusion Criteria

History of alcohol or other substance abuse within the previous 2 years prior to the Screening

I have a condition or had surgery that could affect how my body handles thyroid medication.

I am allergic to Armour Thyroid or its ingredients, synthetic T4, other thyroid meds, or pork.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Armour Thyroid or alternate between Armour Thyroid and synthetic T4 for up to 81 weeks

81 weeks

Dose Conversion

Evaluation of dose conversion from synthetic T4 to Armour Thyroid

Up to 29 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 weeks

Treatment Details

Interventions

• Armour Thyroid

Trial Overview The study compares Armour Thyroid, a natural desiccated thyroid medication, to synthetic T4 (Levothyroxine) in treating hypothyroidism. It will assess the safety and effectiveness of switching from synthetic T4 to Armour Thyroid.

Participant Groups

Group I: Group 2 Experimental Treatment 2 Interventions

Participants will alternate between Armour Thyroid and synthetic T4 for up to 81 weeks.

Group II: Group 1 Experimental Treatment 1 Intervention

Participants will receive Armour Thyroid for up to 81 weeks.

Armour Thyroid is already approved in United States for the following indications:

Approved in United States as Armour Thyroid for:

• Hypothyroidism
• Thyroid nodules and goiters
• Thyroid cancer

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

A survey of 384 Danish patients with hypothyroidism revealed that 69% experienced persistent symptoms despite being treated with levothyroxine, and 84% reported a positive treatment effect from T4/T3 combination therapy.

The study found that many patients are self-adjusting their doses of desiccated thyroid and L-T3, which raises concerns about the risk of overtreatment, as European guidelines on combination therapy are not consistently followed in Denmark.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating Hypothyroidism with Thyroxine/Triiodothyronine Combination Therapy in Denmark: Following Guidelines or Following Trends? Michaelsson, LF., Medici, BB., la Cour, JL., et al.[2022]

In a study of 31 patients with hypothyroidism who were unresponsive to levothyroxine, switching to natural desiccated thyroid (NDT) resulted in significant improvements in quality of life (QOL) and thyroid symptoms over 6 months, as measured by standardized questionnaires.

The EQ-5D-5L utility score increased from 0.214 to 0.606, and the ThyPRO scores showed a marked reduction in symptoms, indicating that NDT may be a beneficial alternative treatment for those not responding to standard levothyroxine therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a role for natural desiccated thyroid in the treatment of levothyroxine unresponsive hypothyroidism? Results from a consecutive case series. Heald, AH., Premawardhana, L., Taylor, P., et al.[2021]

A significant 81.1% of patients treated with levothyroxine (LT4) for hypothyroidism achieved normal TSH levels, indicating effective management of the condition over a follow-up period of at least 12 months.

Approximately 25% of patients switched LT4 formulations within one year, with over 40% switching within two years, suggesting a need for better adherence to treatment protocols and patient education regarding the importance of consistent medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levothyroxine Treatment Adequacy and Formulation Changes in Patients with Hypothyroidism: A Retrospective Study of Real-World Data from the United States. Bianco, AC., Bao, Y., Antunez Flores, O., et al.[2023]

Patients with idiopathic hypothyroidism (IHT) who did not receive immunoactive drugs experienced more frequent disease exacerbations, highlighting the importance of incorporating such therapies.

Combined therapy using splenin and sodium nucleinate significantly improved treatment outcomes, achieving stable IHT compensation in 80.8% and 86.2% of patients, respectively, compared to only 40.9% with conventional thyreoidin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of immunoregulator preparations in the combined treatment of idiopathic hypothyroidism]. Epishin, AV., Khabarova, NA., Grytsiv, VE., et al.[2006]

In a study of 45 hypothyroid patients, 60% preferred combination therapy of L-T4 and L-T3 over L-T4 alone, suggesting a significant preference for this treatment approach.

The preference for combination therapy was linked to specific genetic polymorphisms in the DIO2 and MCT10 genes, indicating that genetic factors may influence treatment preferences and effectiveness in hypothyroid patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypothyroid Patients Encoding Combined MCT10 and DIO2 Gene Polymorphisms May Prefer L-T3 + L-T4 Combination Treatment - Data Using a Blind, Randomized, Clinical Study. Carlé, A., Faber, J., Steffensen, R., et al.[2022]

In a study of patients with primary hypothyroidism, switching from the brand Thyrax to another levothyroxine (LT4) brand resulted in a significant increase in the percentage of patients with abnormal TSH levels, with 63% of those on higher doses becoming hyperthyroid after the switch.

The findings suggest that patients who switch LT4 brands may require careful monitoring and potential dose adjustments, as 24% of patients on lower doses and 63% on higher doses experienced TSH levels outside the normal range after switching.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Forced Dose-Equivalent Levothyroxine Brand Switch on Plasma Thyrotropin: A Cohort Study. Flinterman, LE., Kuiper, JG., Korevaar, JC., et al.[2021]

Oral levothyroxine (LT4) is the standard treatment for hypothyroidism, but concerns exist about the FDA's bioequivalence protocol, which may allow different formulations to be considered interchangeable despite potential differences in how they affect thyroid hormone levels.

Switching between LT4 formulations can lead to significant changes in thyroid-stimulating hormone (TSH) levels, especially in vulnerable populations like the elderly, pregnant women, and children, highlighting the importance of maintaining patients on the same LT4 preparation and monitoring TSH levels if changes are made.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levothyroxine Formulations: Pharmacological and Clinical Implications of Generic Substitution. Benvenga, S., Carlé, A.[2023]

In a study comparing synthetic thyroid medication to desiccated thyroid products over a 3-year period, both groups maintained in-range TSH levels 79% of the time, indicating similar effectiveness in managing hypothyroidism.

There was no significant difference in TSH stability between the two types of thyroid treatments, suggesting that patients can expect comparable outcomes regardless of the medication type they use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thyroid Stimulating Hormone Stability in Patients Prescribed Synthetic or Desiccated Thyroid Products: A Retrospective Study. Kuye, R., Riggs, C., King, J., et al.[2021]

Levothyroxine (L-T4) is the standard treatment for hypothyroidism, and new formulations like liquid solutions and soft gel capsules have been developed to improve absorption and overcome issues with food and drug interactions that affect tablet L-T4.

Studies suggest that liquid L-T4 formulations may help maintain normal TSH levels more effectively over the long term compared to traditional tablet forms, especially in patients with malabsorption issues, indicating a potential advantage in treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Stability of TSH, and Thyroid Hormones, in Patients Treated With Tablet, or Liquid Levo-Thyroxine. Antonelli, A., Elia, G., Ragusa, F., et al.[2021]

L-Thyroxin Henning 100 demonstrated significantly higher bioavailability compared to Eferox 100, leading to higher free thyroxine (fT4) levels and a greater reduction in serum TSH levels after 14 days of treatment in a study involving 60 euthyroid volunteers.

The study suggests that when switching between different LT4 preparations, regular monitoring of serum TSH and fT4 levels is essential to prevent metabolic imbalances, as individual factors like gender and body weight can influence bioavailability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Randomized, double-blind crossover study of bioavailability of levothyroxine]. Krehan, A., Dittmar, M., Hoppen, A., et al.[2019]

Patients with autoimmune thyroid diseases, such as Hashimoto's thyroiditis and Graves' disease, are commonly treated with synthetic L-thyroxine (L-T4), with various formulations available to accommodate different absorption needs.

Recent studies indicate that combining myoinositol with selenium can significantly reduce TSH and antithyroid autoantibodies in patients with subclinical hypothyroidism, suggesting a potential new treatment avenue for improving thyroid function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Medicine in Autoimmune Thyroiditis and Hypothyroidism. Ferrari, SM., Ragusa, F., Elia, G., et al.[2021]

In hypothyroid patients with both Hashimoto's thyroiditis and atypical celiac disease, a higher dose of T4 is required to achieve target TSH levels compared to those without celiac disease, indicating that atypical CD increases the need for T4.

Adhering to a gluten-free diet allowed patients with atypical CD to reach target TSH levels without increasing their T4 dose, suggesting that the diet may improve T4 absorption and management of hypothyroidism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atypical celiac disease as cause of increased need for thyroxine: a systematic study. Virili, C., Bassotti, G., Santaguida, MG., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Treating Hypothyroidism with Thyroxine/Triiodothyronine Combination Therapy in Denmark: Following Guidelines or Following Trends? [2022]

2. India pubmed.ncbi.nlm.nih.gov

Is there a role for natural desiccated thyroid in the treatment of levothyroxine unresponsive hypothyroidism? Results from a consecutive case series. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Levothyroxine Treatment Adequacy and Formulation Changes in Patients with Hypothyroidism: A Retrospective Study of Real-World Data from the United States. [2023]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The use of immunoregulator preparations in the combined treatment of idiopathic hypothyroidism]. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Hypothyroid Patients Encoding Combined MCT10 and DIO2 Gene Polymorphisms May Prefer L-T3 + L-T4 Combination Treatment - Data Using a Blind, Randomized, Clinical Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of a Forced Dose-Equivalent Levothyroxine Brand Switch on Plasma Thyrotropin: A Cohort Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Levothyroxine Formulations: Pharmacological and Clinical Implications of Generic Substitution. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Thyroid Stimulating Hormone Stability in Patients Prescribed Synthetic or Desiccated Thyroid Products: A Retrospective Study. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Stability of TSH, and Thyroid Hormones, in Patients Treated With Tablet, or Liquid Levo-Thyroxine. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

[Randomized, double-blind crossover study of bioavailability of levothyroxine]. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Precision Medicine in Autoimmune Thyroiditis and Hypothyroidism. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Atypical celiac disease as cause of increased need for thyroxine: a systematic study. [2022]