What side effects are associated with this type of intervention?

The most common treatment for hypothyroidism is levothyroxine, a synthetic form of the thyroid hormone thyroxine (T4). Known side effects of levothyroxine include symptoms of hyperthyroidism if the dose is too high, such as palpitations, increased heart rate, anxiety, weight loss, and insomnia. Other potential side effects include bone loss and fractures, particularly in postmenopausal women, and cardiovascular issues like atrial fibrillation. Some patients may also experience allergic reactions to the medication's inactive ingredients. It is important to monitor thyroid hormone levels regularly to adjust the dosage and minimize side effects.

What prior FDA approvals exist?

Levothyroxine (L-T4) is the most commonly FDA-approved treatment for hypothyroidism and has been the standard of care for many years. It is a synthetic form of thyroxine (T4), a hormone normally produced by the thyroid gland. Another FDA-approved treatment is liothyronine (L-T3), a synthetic form of triiodothyronine (T3). Combination therapies involving both levothyroxine and liothyronine have also been explored, although they are not as commonly used due to mixed evidence regarding their efficacy and safety. The North Star study aims to evaluate a new form of thyroid hormone replacement therapy, which may offer an alternative to these existing treatments.

What other types of research exist?

Promising novel alternatives to North Star therapy for hypothyroidism patients include new technologies for steady delivery of L-triiodothyronine and the development of triiodothyronine analogs. These alternatives aim to improve the management of hypothyroidism by providing more consistent hormone levels and potentially better symptom control.

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Hormone Replacement Therapy

Hormone Replacement Therapy for Hypothyroidism

Phase 2

Waitlist Available

Research Sponsored by Neuvosyn Laboratories, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with primary hypothyroidism

On continuous thyroid replacement therapy for at least 6 months before Study Entry

Must not have

Hospitalization for a major illness within 4 weeks prior to Screening

Concomitant use of prohibited medications or supplements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if patients can safely switch from Levothyroxine to North Star therapy while keeping their thyroid hormone levels stable.

Who is the study for?

This trial is for adults with primary hypothyroidism who've been on a stable dose of Levothyroxine for at least 12 weeks. Participants must not be pregnant, agree to use reliable contraception, and cannot have conditions affecting drug absorption or excretion. They shouldn't have had major illness hospitalization recently or be taking certain other medications.

What is being tested?

The study compares the safety and effectiveness of a new hormone therapy called North Star against the standard treatment, Levothyroxine, in people with underactive thyroid glands. It's a Phase 2 trial where patients are randomly assigned to one of the treatments without knowing which one they receive.

What are the potential side effects?

While specific side effects aren't listed here, hormone replacement therapies like North Star and Levothyroxine can cause symptoms such as fatigue, weight changes, hair loss, mood swings, and sensitivity to cold if dosing isn't properly managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with an underactive thyroid.

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I have been on thyroid replacement therapy for at least 6 months.

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I am not pregnant or breastfeeding.

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I have been diagnosed with an underactive thyroid.

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I have been on thyroid replacement therapy for at least 6 months.

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I am not pregnant or breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been hospitalized for a serious illness in the last 4 weeks.

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I am not taking any medications or supplements that are not allowed.

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I am not pregnant, nursing, or planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: North StarExperimental Treatment1 Intervention

Group II: LevothyroxineActive Control1 Intervention

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for hypothyroidism involve thyroid hormone replacement therapies, such as levothyroxine (T4) and liothyronine (T3). Levothyroxine is converted into the active hormone triiodothyronine (T3) in the body, which is essential for regulating metabolism, growth, and development. Some therapies combine both T4 and T3 to better mimic natural thyroid function. This is important for hypothyroidism patients as it helps alleviate symptoms like fatigue, weight gain, and cognitive issues, thereby improving their quality of life.

The Impact of Hypothyroidism on Satisfaction with Care and Treatment and Everyday Living: Results from E-Mode Patient Self-Assessment of Thyroid Therapy, a Cross-Sectional, International Online Patient Survey.Association of Thyroid Hormone Therapy With Quality of Life and Thyroid-Related Symptoms in Patients With Subclinical Hypothyroidism: A Systematic Review and Meta-analysis.Association Between Levothyroxine Treatment and Thyroid-Related Symptoms Among Adults Aged 80 Years and Older With Subclinical Hypothyroidism.