Armour Thyroid vs Synthetic T4 for Hypothyroidism

Recruiting at 150 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Armour Thyroid, a natural thyroid hormone replacement, is as effective and safe as synthetic T4 for individuals with primary hypothyroidism, a condition where the thyroid does not produce enough hormones. Participants will either switch to Armour Thyroid or alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The trial seeks individuals who have had primary hypothyroidism for over a year and are stable on their current synthetic T4 treatment. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. Participants have the opportunity to contribute to potentially groundbreaking advancements in hypothyroidism treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Armour Thyroid is usually well-tolerated, but experiences can vary. In one study, about 19.2% of patients stopped using Armour Thyroid within six months due to side effects like lack of improvement or negative symptoms. Another study found that some individuals experienced issues such as a faster heartbeat or chest pain while taking Armour Thyroid. However, many reported positive effects, including increased energy and improved sleep.

When comparing Armour Thyroid to synthetic T4, a study found that fewer patients on Armour Thyroid reported fatigue and weight gain than those on synthetic T4. This suggests that some individuals might tolerate Armour Thyroid better than synthetic T4, although experiences can differ. It is important to consult a healthcare provider to determine the best option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatment for hypothyroidism, which typically involves synthetic T4 (like levothyroxine), Armour Thyroid is unique because it's made from desiccated pig thyroid glands, providing both T3 and T4 hormones. This could potentially offer a more balanced hormone replacement for certain patients who don't feel optimal on synthetic T4 alone. Researchers are excited about these treatments because they offer the possibility of improved symptom relief and overall well-being for patients who struggle with conventional therapies. Additionally, the trial includes an arm where participants alternate between Armour Thyroid and synthetic T4, which might reveal synergistic benefits and provide new insights into personalized thyroid hormone replacement strategies.

What evidence suggests that this trial's treatments could be effective for hypothyroidism?

Research has shown that many patients feel better on Armour Thyroid compared to synthetic T4, even when thyroid levels appear normal in tests. Participants in this trial will receive either Armour Thyroid alone or alternate between Armour Thyroid and synthetic T4. Patients have reported more energy, better sleep, and increased alertness with Armour Thyroid. Some studies suggest Armour Thyroid might be more effective for those who still experience symptoms despite using synthetic T4. However, reviews are mixed, with some individuals experiencing positive effects and others not. Overall, Armour Thyroid is considered a good option for those who continue to have symptoms with synthetic T4. ^{1 3 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10801060/

Natural desiccated thyroid for the treatment of ... I have a little more energy, I am less puffy minded and more alert. Also, I sleep better. NDT generally made me feel better then when I was on Thyroxine. It has ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8089975/

A Tale of Two Therapies- A Comparison of Armour Thyroid ... Many patients report continued hypothyroid symptoms despite normal TSH values on levothyroxine and request to switch to desiccated animal ...

3. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M21-341

A Study to Assess the Safety and Efficacy of Oral Armour ... This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are ...

4. sps.nhs.uk sps.nhs.uk/articles/review-of-clinical-evidence-on-use-of-desiccated-thyroid-extract-products/

Avoid prescribing desiccated (natural) thyroid extract – SPS Advice for prescribers on liothyronine use in the NHS, lists thyroid extract products (e.g. Armour thyroid and ERFA Thyroid) as not recommended.

5. drugs.com drugs.com/compare/np-thyroid-vs-thyroid-desiccated

Comparing NP Thyroid vs Thyroid Desiccated Thyroid desiccated has an average rating of 5.4 out of 10 from a total of 641 ratings on Drugs.com. 42% of reviewers reported a positive effect, while 44% ...

6. drugs.com drugs.com/compare/armour-thyroid-vs-nature-throid

Armour Thyroid vs Nature-Throid Comparison Armour Thyroid has an average rating of 6.4 out of 10 from a total of 256 ratings on Drugs.com. 52% of reviewers reported a positive effect, while 29% reported ...

7. webmd.com webmd.com/drugs/2/drug-154794/np-thyroid-oral/details

Desiccated Thyroid (Armour Thyroid, NP Thyroid, and others) Desiccated thyroid may cause your heart rate to increase or become abnormal. You may also have chest pain.