Hormone Replacement Therapy for Hypothyroidism

No longer recruiting at 38 trial locations

Overseen By Sention Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sention Therapeutics, LLC

Must be taking: Levothyroxine

Disqualifiers: Pregnancy, Breastfeeding, Other clinical study, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new hormone replacement therapy, ST-1891, for individuals with primary hypothyroidism, a condition where the thyroid doesn't produce enough hormones. Researchers aim to assess the safety and effectiveness of ST-1891 compared to levothyroxine, a synthetic thyroid hormone commonly used for treatment. Participants will receive either ST-1891 or levothyroxine to determine which is more effective. This trial suits those who have maintained a stable dose of levothyroxine for at least three months and have managed hypothyroidism for over a year. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must have been on a stable dose of levothyroxine for at least 3 months before joining. You cannot start or change other medications during the trial.

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

Research has shown that ST-1891, the hormone replacement therapy under investigation, exhibited manageable side effects in earlier studies. This suggests it might be safe for individuals with hypothyroidism. However, the study is in Phase 2, so researchers are still gathering data to confirm its safety in humans.

In contrast, levothyroxine, the medication compared to ST-1891, is a well-established treatment for hypothyroidism. The FDA has already approved it for this condition, and it is generally considered safe when used as directed.

Both treatments are under study to ensure their safety and effectiveness for participants. If considering joining the trial, these points may reassure you about the safety of the treatments being tested. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hypothyroidism?

Unlike the standard treatment for hypothyroidism, which typically involves levothyroxine, ST-1891 is unique because it may offer a new mechanism of action. Levothyroxine works by supplementing the hormone thyroxine, but ST-1891 could potentially target different pathways or offer improved absorption or stability, leading to more effective management of symptoms. Researchers are excited because this could mean faster relief of symptoms or better overall control of thyroid hormone levels, addressing some limitations of current therapies.

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

Research has shown that levothyroxine, which participants in this trial may receive, is a well-known treatment for hypothyroidism. It helps most patients by normalizing their thyroid hormone levels. This medication replaces the hormone that the thyroid gland cannot produce sufficiently. Studies have found that it manages symptoms like tiredness and weight gain, making it a dependable option for many.

ST-1891 is another treatment option in this trial, under investigation for its potential to treat primary hypothyroidism. Early results suggest it might help by replacing the lower levels of T3 and T4 hormones, which are crucial for controlling metabolism and energy. While researchers are still collecting more detailed data on its effectiveness, it works similarly to current treatments, offering a hopeful alternative for patients. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

On a stable daily dose of levothyroxine for the 3 months prior to Screening

Willing to give written informed consent for the Study

You have been taking levothyroxine for your thyroid for at least a year before the screening.

Exclusion Criteria

Anticipated initiation or change in concomitant medications

Currently participating in another clinical study or have received active treatment with an investigational drug within 30 days or 5 half-lives of the investigational drug of Screening, whichever is longer

You have a medical condition or had surgery that might affect how your body processes ST-1891 or levothyroxine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hormone replacement therapy with ST-1891 or levothyroxine

8-12 weeks

Crossover

Participants switch from one treatment to the other to evaluate comparative efficacy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Levothyroxine
• ST-1891

How Is the Trial Designed?

Group I: ST-1891 Experimental Treatment 1 Intervention

Group II: Levothyroxine Active Control 1 Intervention

Levothyroxine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Levothyroxine for:

• Hypothyroidism
• Thyroid cancer
• Euthyroid goiters

Approved in European Union as Levothyroxine for:

• Hypothyroidism
• Thyroid cancer
• Euthyroid goiters

Approved in Canada as Levothyroxine for:

• Hypothyroidism
• Thyroid cancer
• Euthyroid goiters

Who Is Running the Clinical Trial?

Sention Therapeutics, LLC

Lead Sponsor

Trials

1

Recruited

490+

Published Research Related to This Trial

In a study of 36 young adult patients, those with congenital hypothyroidism (CH) required a significantly higher daily dosage of levothyroxine (l-T4) to achieve normal thyroid hormone levels compared to those who had hypothyroidism after total thyroidectomy (1.73 vs 2.16 μg/kg).

Despite achieving normal thyroid hormone levels, patients with CH had higher serum TSH levels than those with surgical hypothyroidism, suggesting that their hypothalamus-pituitary-thyroid axis may be set differently due to a lack of thyroid hormones since fetal life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The different requirement of L-T4 therapy in congenital athyreosis compared with adult-acquired hypothyroidism suggests a persisting thyroid hormone resistance at the hypothalamic-pituitary level. Bagattini, B., Cosmo, CD., Montanelli, L., et al.[2016]

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]

Current evidence suggests that combining T(3) and T(4) treatment may improve quality of life and cognitive function in hypothyroid patients, indicating a potential shift from traditional levothyroxine therapy alone.

The review highlights the need for personalized thyroid hormone replacement regimens and calls for further randomized controlled studies to explore the benefits and optimal ratios of T(4) and T(3) in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination treatment with T4 and T3: toward personalized replacement therapy in hypothyroidism? Biondi, B., Wartofsky, L.[2022]

Liquid levothyroxine (LT4) formulations, particularly Tirosint SOL, are more effective than tablet forms for patients with malabsorption issues, leading to better hormonal control and less frequent TSH measurements.

The liquid LT4 is safe and effective for various populations, including newborns and pregnant women, but caution is needed in neonates due to a higher risk of TSH suppression compared to tablet LT4.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expert opinion on liquid L-thyroxine usage in hypothyroid patients and new liquid thyroxine formulation - Tirosint SOL [Opinia ekspertów dotycząca stosowania płynnej postaci lewotyroksyny oraz nowego preparatu Tirosint SOL u chorych na niedoczynność tarczycy]. Gietka-Czernel, M., Hubalewska-Dydejczyk, A., Kos-Kudła, B., et al.[2021]

The new formulation of levothyroxine (L-T4) has been shown to be bioequivalent to the current formulation, with a geometric mean ratio of 99.3% for the area under the curve (AUC) and 101.7% for maximum concentration (Cmax), ensuring consistent therapeutic effects.

This reformulated L-T4 meets strict potency specifications and demonstrates dosage form proportionality, allowing for more precise dosing tailored to individual patient needs, which enhances safety in thyroid hormone management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New levothyroxine formulation meeting 95-105% specification over the whole shelf-life: results from two pharmacokinetic trials. Gottwald-Hostalek, U., Uhl, W., Wolna, P., et al.[2018]

Levothyroxine Sodium is an important thyroid hormone replacement therapy for hypothyroidism and has various applications, including treating goiters and certain thyroid cancers, highlighting its efficacy in managing thyroid-related conditions.

Recent patents have focused on improving the stability and formulation of Levothyroxine Sodium due to challenges like photosensitivity and oxidation, which could lead to better and more cost-effective treatments in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levothyroxine Sodium - Thyroid Hormone Replacement Therapy for Hypothyroidism: A Review of Patent Literature. Upadhyay, U., Vora, PA., Patel, R., et al.[2023]

Levothyroxine (LT4) is the preferred treatment for hypothyroidism among Irish endocrinologists, with 81.3% of surveyed doctors supporting its use, although some also consider combination therapies like liothyronine for certain patients.

A notable 51% of endocrinologists might prescribe thyroid hormones to euthyroid patients under specific conditions, such as for women with thyroid auto-antibodies seeking pregnancy, indicating a nuanced approach to treatment despite existing guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Thyroid Hormones in Hypothyroid and Euthyroid Patients: A THESIS questionnaire survey of members of the Irish Endocrine Society. Mustafa, M., Ali, E., McGowan, A., et al.[2023]

In a study of 32 adults with primary hypothyroidism, the fixed combination therapy of levothyroxine/liothyronine (LT4/LT3) resulted in significantly lower free T4 levels compared to standard LT4 treatment, but did not affect TSH or T3 levels.

Despite some patients on LT4/LT3 experiencing elevated T3 levels and an increased heart rate, the combination therapy did not show clear clinical benefits in terms of lipid profile, body weight, or quality of life, suggesting that further research is needed to explore its efficacy in specific populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of hypothyroidism with levothyroxine plus liothyronine: a randomized, double-blind, crossover study. Kaminski, J., Miasaki, FY., Paz-Filho, G., et al.[2023]

In a study of 59 euthyroid children with Hashimoto thyroiditis, treatment with levothyroxine (L-T4) significantly reduced thyroid volume over 36 months, with a notable decrease in the treatment group compared to the observation group.

Despite the reduction in thyroid volume, L-T4 treatment did not affect thyroid function or serum thyroid antibodies, indicating that while it may help manage thyroid size, it does not alter the underlying autoimmune condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levothyroxine Treatment of Euthyroid Children with Autoimmune Hashimoto Thyroiditis: Results of a Multicenter, Randomized, Controlled Trial. Dörr, HG., Bettendorf, M., Binder, G., et al.[2022]

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ST-1891-201 is a multicenter, randomized, double-blind, partial crossover, Phase 2 study evaluating the safety and efficacy of hormone replacement therapy with ...

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Hormone Replacement Therapy for Hypothyroidism

This trial is testing a new hormone replacement therapy called ST-1891 in patients with primary hypothyroidism. The goal is to help patients whose thyroid ...

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Metabolic Effects of Liothyronine Therapy in Hypothyroidism

Overt hypothyroidism has a prevalence of 0.3–2% in the general population (1, 2). Since 1891, hypothyroidism has been treated with replacement therapy, ...

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clinicaltrialsarena.com/features/oncology-cell-therapy-termination-investigator/

Pipeline Moves: Investigator-led oncology cell therapy trial ...

ST-1891 is a hormone replacement therapy administered orally. The asset acts by replacing decreased T3/T4 hormone levels of hypothyroidism ...

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A multicenter, randomized, double-blind, partial crossover, Phase 2 study evaluating the safety and efficacy of hormone replacement therapy with ST-1891 ...

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Trial | NCT05412979

ST-1891-201 is a multicenter, randomized, double-blind, partial crossover, Phase 2 study evaluating the safety and efficacy of hormone replacement therapy ...