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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 29 of the maintenance period
Awards & highlights

Study Summary

This trial studies a new type of thyroid medication to determine a target dose conversion factor and assess its safety and tolerability in people with hypothyroidism.

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.Check my eligibility
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.See study design
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
Select...
I am 18-65 years old, have chronic hypothyroidism, and have been on a stable dose of levothyroxine for at least 3 months.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose conversion factor
Secondary outcome measures
Proportion of subjects enrolled with normalized TSH
Thyroid hormone concentrations

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
2009
Completed Phase 3
~70

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.

Find a Location

Who is running the clinical trial?

Xeris PharmaceuticalsLead Sponsor
18 Previous Clinical Trials
618 Total Patients Enrolled
Valentina Conoscenti, MDStudy DirectorXeris Pharmaceuticals, Inc.

Media Library

Levothyroxine Sodium (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05823012 — Phase 2
~0 spots leftby May 2024
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