What is the mechanism of action of this treatment?

Levothyroxine sodium, a synthetic form of the thyroid hormone thyroxine (T4), is the most common treatment for hypothyroidism. It works by supplementing the deficient hormone, which is then converted into the active form triiodothyronine (T3) in the body. This hormone replacement is essential for regulating metabolism, energy production, and cellular function. For hypothyroidism patients, this treatment is crucial as it helps alleviate symptoms like fatigue, weight gain, and cognitive impairment by restoring normal thyroid hormone levels.

What side effects are associated with this type of intervention?

Levothyroxine sodium, a common treatment for hypothyroidism, can cause side effects primarily related to overdosage, leading to symptoms of hyperthyroidism such as increased heart rate, anxiety, weight loss, and tremors. Other side effects may include headache, insomnia, and heat intolerance. Rare but severe side effects can include chest pain and allergic reactions.

What prior FDA approvals exist?

Levothyroxine sodium, a synthetic form of the thyroid hormone thyroxine (T4), is the most commonly prescribed medication for hypothyroidism and has been FDA-approved for many years. It is used to restore normal thyroid hormone levels and alleviate symptoms of hypothyroidism. Other related drugs include liothyronine (synthetic T3) and combination therapies of T4 and T3, although these are less commonly used. The trial XP-8121 is studying a new formulation of levothyroxine sodium for once-weekly subcutaneous injections, which aims to improve convenience and adherence compared to daily oral dosing.

What other types of research exist?

Promising alternatives to XP-8121 for hypothyroidism treatment include: 1) Liquid levothyroxine formulations, which have shown therapeutic equivalence to tablet forms and may offer better absorption and convenience. 2) Combination therapy with levothyroxine (LT4) and liothyronine (LT3), although not consistently beneficial in trials, some patients prefer it and report subjective improvements. 3) New selective RET inhibitors like Selpercatinib and Pralsetinib, primarily for thyroid cancers, may offer insights into novel thyroid hormone regulation mechanisms.

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Hormone Therapy

New Thyroid Medication for Hypothyroidism

Phase 2

Waitlist Available

Research Sponsored by Xeris Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Male or female between the ages of 18 and 65 years (inclusive) at Screening, with chronic hypothyroidism and on a stable dose of oral levothyroxine (Synthroid or an FDA-approved generic equivalent to Synthroid) or, if in the pharmacokinetic substudy, Synthroid only for at least 3 months.

Be older than 18 years old

Must not have

Current levothyroxine total daily dose either <50 μg or >375 μg.

Current use of combined thyroid treatment (i.e., Synthroid plus liothyronine or Synthroid plus Armour Thyroid) and/or any other levothyroxine aside from those used in the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 29 of the maintenance period

Awards & highlights

No Placebo-Only Group

Summary

This trial tests injections of a thyroid hormone medication in patients with hypothyroidism. It aims to find the right dose when switching from daily pills to injections and ensure the treatment is safe and well-tolerated. Levothyroxine, a common treatment for hypothyroidism, has been traditionally administered daily, but recent studies suggest less frequent doses may improve adherence.

Who is the study for?

This trial is for adults aged 18-65 with chronic hypothyroidism who have been on a stable dose of oral levothyroxine for at least 3 months. Participants must have normal free thyroxine and TSH levels. Those allergic to levothyroxine, on high doses (>2 μg/kg/day), or using combined thyroid treatments cannot join.

What is being tested?

The study tests XP-8121 (levothyroxine sodium) given as weekly subcutaneous injections to find the right dose conversion from oral levothyroxine. It's an open-label, single-arm study with screening, titration, and maintenance periods ending with a final visit.

What are the potential side effects?

Potential side effects are not specified in the provided information but may be similar to those of standard levothyroxine treatment which can include symptoms like fatigue, weight changes, hair loss, mood swings, and sensitivity to temperature.

Eligibility Criteria

Inclusion Criteria

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

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I am 18-65 years old, have chronic hypothyroidism, and have been on a stable dose of levothyroxine for at least 3 months.

Exclusion Criteria

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

Select...

My daily dose of levothyroxine is either less than 50 μg or more than 375 μg.

Select...

I am not using any thyroid treatments other than those provided in the study.

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I am taking more than 2 micrograms per kilogram of my body weight of levothyroxine daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 29 of the maintenance period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 29 of the maintenance period

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29 of the maintenance period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose conversion factor

Secondary study objectives

Proportion of subjects enrolled with normalized TSH

Thyroid hormone concentrations

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: XP-8121Experimental Treatment1 Intervention

XP-8121 100 to 1500 μg subcutaneous injection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

levothyroxine sodium

2023

Completed Phase 3

~120

0 / 4Eligibility 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

Levothyroxine sodium, a synthetic form of the thyroid hormone thyroxine (T4), is the most common treatment for hypothyroidism. It works by supplementing the deficient hormone, which is then converted into the active form triiodothyronine (T3) in the body. This hormone replacement is essential for regulating metabolism, energy production, and cellular function. For hypothyroidism patients, this treatment is crucial as it helps alleviate symptoms like fatigue, weight gain, and cognitive impairment by restoring normal thyroid hormone levels.

Treatment of iodine deficiency goiter with iodine, levothyroxine or a combination of both.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 Between Levothyroxine Treatment and Thyroid-Related Symptoms Among Adults Aged 80 Years and Older With Subclinical Hypothyroidism.