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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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently recruiting participants?

"According to the latest data hosted by clinicaltrials.gov, this medical trial is still actively enrolling participants. It was initially published on April 21st 2023 and most recently updated May 4th 2023."

Answered by AI

Who is eligible to enroll in this medical trial?

"This clinical trial is looking to enrol 44 individuals that suffer from hypothyroidism, and are aged between 18-65 years old."

Answered by AI

Is this research open to individuals younger than seventy years of age?

"The protocol for this study necessitates that candidates are 18 years old or above, while still being under the age of 65."

Answered by AI

How is the safety profile of XP-8121 when used by human subjects?

"The safety of XP-8121 was gauged at a 2 since although there is evidence to suggest it safe, efficacy data has yet to be collected."

Answered by AI

How many participants have joined this trial thus far?

"Affirmative. According to the details provided on clinicaltrials.gov, this research is ongoing and in need of volunteers; it was first advertised on April 21st 2023 with a last update being made on May 4th 2023 for 44 participants at 3 distinct medical centres."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've struggled with hypothyroidism for 20 years. I've rarely felt normal even though my blood tests will come back within normal range. I would love to find an alternative that has better results so feeling normal is possible and not just defined by being within the range on a blood test.
PatientReceived 2+ prior treatments
~7 spots leftby May 2024