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Last Updated: April 20, 2025

CLINICAL TRIALS PROFILE FOR EUTHYROX


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All Clinical Trials for Euthyrox

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01379170 ↗ Thyroid Study Type 2 Diabetes Mellitus (T2DM) Unknown status Maastricht University Medical Center Phase 4 2011-06-01 Background of the study: Thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to promote weight loss, which could be beneficial for treating obesity, and type 2 diabetes. Thyroid hormone treatment stimulates energy expenditure resulting in increased body heat production, in which brown adipose tissue play an important role. It is hypothesized that thyroid hormones would induce increased energy expenditure via a process called mitochondrial uncoupling, thereby creating an inefficient energy status. Indeed, an in vivo study showed a 70% increased flux through the tricarboxylic acid cycle (TCA) and an unchanged ATP synthesis rate upon T3 treatment in lean, healthy young men. The disproportionate increase in TCA flux compared with ATP synthesis suggests increased mitochondrial uncoupling. It is however unknown whether increased mitochondrial uncoupling would increase fat oxidation and exerts favorable effects on insulin sensitivity. There is compelling evidence that type 2 diabetic patients have high levels of fat accumulation in non-adipose tissues, such as skeletal muscle, heart and liver. Ectopic fat accumulation is related to insulin resistance, however, why this fat accumulates in peripheral organs is not known. Recently, studies reported compromised mitochondrial oxidative capacity in type 2 diabetic patients and first-degree relatives of diabetic patients, suggested to play an important role. Therefore, subjects suffering from overweight and/or type 2 diabetes with overt hypothyroidism form an interesting group for examining the metabolic effects of thyroid hormone treatment, as less is known about the effects of thyroid hormone treatment in these groups. Objective of the study: The purpose of this study is to evaluate whether thyroid hormone replacement therapy in type 2 diabetic patients suffering from overt hypothyroidism, will improve muscular mitochondrial function, lower ectopic fat accumulation in muscle and liver, increase brown adipose tissue activity and enhance insulin sensitivity. Study design: Type 2 diabetic patients diagnosed with hypothyroidism will undergo 3 months of thyroid hormone replacement therapy (THRT) (Euthyrox®, Merck, Germany). Patients will be metabolically characterized (such as insulin sensitivity and fat accumulation in peripheral tissues) before and after this thyroid hormone replacement therapy. Study population: 17 type 2 diabetic patients diagnosed with overt hypothyroidism (9 from the Netherlands, 8 from Germany which will only do the PET-CT) Primary study parameters/outcome of the study: Thyroid hormone-induced change in whole body insulin sensitivity (change in insulin-stimulated glucose disposal) and muscle mitochondrial function. Secondary study parameters/outcome of the study (if applicable): Thyroid hormone-induced change of lipid content in skeletal muscle and liver and brown adipose tissue activity.
NCT01458600 ↗ Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study) Completed Mikael Lantz Phase 4 2006-09-01 AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves´ disease Background - Already at diagnosis of Graves disease approximately 98% of the patients have morphological changes of the retrobulbar tissue concordant with ophthalmopathy. Factors known to induce clinical symptoms of ophthalmopathy are mainly unknown. An interesting observation is that a patient with stable and inactive Graves´ disease developed ophthalmopathy when treated with a glitazone due to diabetes type 2. Glitazones have been shown to increase differentiation of orbital preadipocytes to mature adipocytes. Glitazones are PPAR-gamma agonists and recently diclofenac have been shown to interact with PPAR-gamma in physiological concentrations. Other non-steroidal antiinflammatory drugs, NSAID, like indomethacin lack this effect. In addition, diclofenac inhibit synthesis of prostaglandins which also may be of importance because the natural ligand to PPAR-gamma is prostaglandin J. Inflammation and adipogenesis are hallmarks of the pathological process in Graves ophthalmopathy and NSAID like diclofenac may affect both. There is only one earlier study demonstrating effects of NSAID (indomethacin) in 7 patients with effects on soft tissue symptoms, eye muscle symptoms and eye protrusion. Aim - to investigate if diclofenac can prevent ophthalmopathy and/or progress of ophthalmopathy. Specific aims: 1. To study the frequency of clinical ophthalmopathy in Graves´ disease after 12 months treatment with or without diclofenac. 2. To study the frequency of progress of clinical signs and symptoms in ophthalmopathy after 12 months treatment with or without diclofenac. 3. To study the frequency of optic neuropathy in clinical ophthalmopathy after 12 months treatment with or without diclofenac. Study plan and randomisation - 150 patients with newly diagnosed Graves´disease without ophthalmopathy will be treated with anti-thyroid drugs and L-thyroxin (block and replace) according to clinical routine for 18 months. These patients will be randomized to diclofenac 50 mg twice daily or not for 12 months.
NCT01848171 ↗ Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism Active, not recruiting Shandong Provincial Hospital Phase 4 2013-07-01 Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. The present study was designed to investigate whether L-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress.
NCT02512978 ↗ Thyroid Hormone Replacement for Hypothyroidism and Acute Myocardial Infarction(ThyroHeart-AMI) Unknown status Beijing Anzhen Hospital Phase 4 2015-08-01 Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Euthyrox

Condition Name

Condition Name for Euthyrox
Intervention Trials
Hypothyroidism 3
Subclinical hypothyroïdism 2
Graves´ Disease 1
Healthy 1
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Condition MeSH

Condition MeSH for Euthyrox
Intervention Trials
Hypothyroidism 5
Myocardial Infarction 1
Eye Diseases 1
Infarction 1
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Clinical Trial Locations for Euthyrox

Trials by Country

Trials by Country for Euthyrox
Location Trials
China 4
Sweden 1
Netherlands 1
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Clinical Trial Progress for Euthyrox

Clinical Trial Phase

Clinical Trial Phase for Euthyrox
Clinical Trial Phase Trials
Phase 4 6
Phase 1 1
N/A 1
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Clinical Trial Status

Clinical Trial Status for Euthyrox
Clinical Trial Phase Trials
Unknown status 3
Completed 2
Not yet recruiting 2
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Clinical Trial Sponsors for Euthyrox

Sponsor Name

Sponsor Name for Euthyrox
Sponsor Trials
The Luhe Teaching Hospital of the Capital Medical University 2
Chinese Academy of Medical Sciences, Fuwai Hospital 2
Hawler Medical University 1
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Sponsor Type

Sponsor Type for Euthyrox
Sponsor Trials
Other 21
Industry 1
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Transforming Hypothyroidism Treatment: Updates on Levothyroxine Clinical Trials, Market Analysis, and Projections

Introduction to Levothyroxine and Hypothyroidism

Levothyroxine, a synthetic form of the thyroid hormone thyroxine (T4), is a cornerstone in the treatment of hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormones. The drug is widely used and has been a subject of extensive research and development to improve its delivery and efficacy.

Clinical Trials Update: Xeris Biopharma's XP-8121

Recent clinical trials have focused on improving the administration and efficacy of levothyroxine. Xeris Biopharma's XP-8121, a novel subcutaneous (SC) formulation of levothyroxine, has shown promising results.

Phase 2 Clinical Data

In a Phase 2 study, Xeris Biopharma announced positive topline data for XP-8121. This study involved 46 patients with hypothyroidism and aimed to determine a target dose conversion factor from oral levothyroxine to the SC formulation. Key findings include:

  • Predictable Bioavailability and Sustained Levels: The XeriSol™ formulation enabled predictable bioavailability and sustained levels of levothyroxine in a once-weekly SC presentation[1].
  • Reduced Drug Dosage: Participants normalized TSH/T4 levels using 45% less drug than their daily oral dose on a weekly basis[1].
  • Patient Satisfaction: Participants rated higher treatment satisfaction with XP-8121 compared to oral levothyroxine, with 72% indicating a strong preference for the SC route of administration[1].

Safety and Tolerability

The study also assessed the safety and tolerability of XP-8121. The results showed that the majority of treatment-emergent adverse events (TEAEs) were mild or moderate, with no serious adverse events or deaths reported. Injection site reactions were minimal, and no participants discontinued the study due to these reactions[1].

Market Analysis: Global Levothyroxine Market

The global levothyroxine market is experiencing significant growth driven by several factors.

Market Size and Growth

  • The global levothyroxine market was valued at USD 3951.2 million in 2024 and is projected to reach USD 5027.029823 million by 2031, with a compound annual growth rate (CAGR) of 3.50% from 2024 to 2031[5].
  • The levothyroxine sodium API market, specifically, was valued at US$ 31 million in 2023 and is anticipated to reach US$ 42 million by 2030, with a CAGR of 4.5% during the forecast period[2].

Regional Market Dynamics

  • North America: This region accounted for a significant share of the market, with the United States contributing USD 1247 million in 2024 and expected to grow at a CAGR of 1.5% from 2024 to 2031[5].
  • Europe: Europe held more than 30% of the global revenue, with a market size of USD 1185.36 million in 2024 and a projected CAGR of 2.2% from 2024 to 2031[5].
  • Asia Pacific: This region is expected to grow at a CAGR of 5.5% from 2024 to 2031, with a market size of USD 908.78 million in 2024[5].

Factors Driving Market Growth

Rising Incidence of Thyroid Disorders

The increasing prevalence of thyroid disorders globally is a major driver of the levothyroxine market. As the population ages, the incidence of hypothyroidism and other thyroid-related conditions is expected to rise, fueling the demand for levothyroxine-based medications[5].

Improving API Purity and Consistency

Manufacturers are focusing on enhancing the purity and consistency of levothyroxine sodium API to meet stringent regulatory standards. This improvement in quality is crucial for maintaining patient safety and efficacy[2].

Expanding Pharmaceutical Production Capacities

Increasing pharmaceutical production capacities, especially in emerging markets, are supporting market growth. These regions are ramping up production to meet local demand and export requirements, contributing to the overall market expansion[2].

Generic Product Interchangeability

A real-world case study sponsored by the FDA addressed concerns about the interchangeability of generic levothyroxine products. The study found that patients who switched among different generic products maintained the same level of thyroid function as those who used a single product consistently. This evidence helps mitigate concerns over generic product switching[3].

Future Outlook and Regulatory Pathway

Phase 3 Pivotal Study Program

Xeris Biopharma is expected to engage in an FDA End-of-Phase 2 interaction by the end of the year to facilitate a Phase 3 pivotal study program for XP-8121. This step is crucial for advancing the drug towards regulatory approval and commercialization[1].

Market Impact of New Formulations

The introduction of new formulations like XP-8121 could significantly impact the market by offering patients more convenient and effective treatment options. The once-weekly SC administration could improve compliance and patient satisfaction, potentially shifting market dynamics in favor of such innovative products[1].

Key Takeaways

  • Clinical Trials: Xeris Biopharma's XP-8121 has shown promising results in Phase 2 clinical trials, offering a once-weekly SC formulation with predictable bioavailability and higher patient satisfaction.
  • Market Growth: The global levothyroxine market is expected to grow at a CAGR of 3.50% from 2024 to 2031, driven by the rising incidence of thyroid disorders and improvements in API purity and consistency.
  • Regional Dynamics: North America, Europe, and Asia Pacific are key regions driving market growth, with varying CAGRs reflecting different market conditions.
  • Generic Interchangeability: FDA-sponsored studies have alleviated concerns over generic product switching, ensuring consistent thyroid function across different generic products.

FAQs

What is the current status of Xeris Biopharma's XP-8121 clinical trials?

Xeris Biopharma has completed a Phase 2 study for XP-8121, showing positive topline data. The company is now preparing for an FDA End-of-Phase 2 interaction to facilitate a Phase 3 pivotal study program[1].

How does the once-weekly SC formulation of levothyroxine compare to daily oral administration?

The once-weekly SC formulation of levothyroxine (XP-8121) allows for predictable bioavailability and sustained levels of the hormone, using 45% less drug than the daily oral dose on a weekly basis. It also offers higher patient satisfaction and convenience[1].

What are the key drivers of the global levothyroxine market growth?

The rising incidence of thyroid disorders, improvements in API purity and consistency, and expanding pharmaceutical production capacities are major drivers of the global levothyroxine market growth[2][5].

Is switching between different generic levothyroxine products safe?

Yes, an FDA-sponsored study found that switching among different generic levothyroxine products did not result in clinically significant changes in thyroid function, alleviating concerns over generic product switching[3].

What is the projected market size of the global levothyroxine market by 2031?

The global levothyroxine market is projected to reach USD 5027.029823 million by 2031, growing at a CAGR of 3.50% from 2024 to 2031[5].

Sources

  1. Xeris Biopharma Announces Positive Topline Phase 2 Clinical Data of Its Investigational XeriSol™-Formulated Once-Weekly Subcutaneous (SC) Levothyroxine (XP-8121). XerisPharma.
  2. Global Levothyroxine Sodium API Market Research Report 2024. Valuates Reports.
  3. Real-World Case Study of Levothyroxine Use And Generic Switching. FDA.
  4. Xeris Biopharma Announces Plans for a Phase II Dose-Finding Study for Its Investigational Subcutaneous (SC) Levothyroxine (XP-8121) as Replacement Therapy for Hypothyroidism. XerisPharma.
  5. Levothyroxine Market Report 2024 (Global Edition). Cognitive Market Research.

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