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Small Molecule Inhibitor

Linsitinib for Thyroid Eye Disease (LIDS Trial)

Phase 2 & 3
Recruiting
Research Sponsored by VasaraGen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale) for the most severely affected eye (primary study eye) at Screening and Baseline
Confirmed active TED (not sight-threatening but has an appreciable impact on daily life, with onset (as determined by patient records) within 12 months prior to the Baseline visit and usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
Timeline
Screening 1 day
Treatment 24 weeks
Follow Up 5 days
Awards & highlights

LIDS Trial Summary

This trial is testing a new drug to see if it is safe and effective in treating people with active, moderate to severe thyroid eye disease.

Who is the study for?
This trial is for people with active, moderate to severe thyroid eye disease (TED) that affects daily life. They should have had TED symptoms within the last year and not need immediate eye surgery or other treatments during the study. Participants must also have controlled thyroid function or mild thyroid issues.Check my eligibility
What is being tested?
The trial tests Linsitinib, an oral medication taken twice a day, against a placebo to see if it's safe and effective for treating TED over 24 weeks. Linsitinib targets a specific protein involved in TED development.See study design
What are the potential side effects?
While specific side effects of Linsitinib are not listed here, similar medications can cause digestive issues, fatigue, skin reactions, changes in blood sugar levels and liver enzymes. Side effects vary from person to person.

LIDS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Graves' Disease or Hashimoto's with severe thyroid eye disease.
Select...
I have active thyroid eye disease impacting my daily life, diagnosed within the last year.
Select...
My thyroid function is normal or mildly off (not more than 50% from normal levels).
Select...
I don't need eye surgery or treatment now or during the study.

LIDS Trial Timeline

Screening ~ 1 day
Treatment ~ 24 weeks
Follow Up ~5 days
This trial's timeline: 1 day for screening, 24 weeks for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Subjects who are Proptosis Responders at Week 24
Secondary outcome measures
Change from Baseline in Proptosis to Week 24 (Study Eye)
Change from Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24.
Percentage of Subjects who are CAS Categorical Responders at Week 24 (Study Eye)
+2 more

LIDS Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Low DoseActive Control1 Intervention
Active Arm Low Dose Linsitinib
Group II: High DoseActive Control1 Intervention
Active Arm High Dose Linsitinib
Group III: PlaceboPlacebo Group1 Intervention
Placebo Arm

Find a Location

Who is running the clinical trial?

VasaraGen, Inc.Lead Sponsor
Sling Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Exophthalmos
75 Patients Enrolled for Exophthalmos

Media Library

Linsitinib (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05276063 — Phase 2 & 3
Exophthalmos Research Study Groups: Placebo, Low Dose, High Dose
Exophthalmos Clinical Trial 2023: Linsitinib Highlights & Side Effects. Trial Name: NCT05276063 — Phase 2 & 3
Linsitinib (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05276063 — Phase 2 & 3
Exophthalmos Patient Testimony for trial: Trial Name: NCT05276063 — Phase 2 & 3

Frequently Asked Questions

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

Are other healthcare facilities also participating in this research project?

"There are a total of 17 medical centres running this trial, which include Kellogg Eye Center in Ann Arbor, UC San Diego Health in La Jolla, and Byers Eye Institute - Stanford University in Palo Alto."

Answered by AI

How many volunteers are enrolling in this experiment?

"In order to move forward, this study requires 75 willing and eligible participants. If you are interested and able, please consider enrolling at one of the many sites, such as Kellogg Eye Center in Ann Arbor, Michigan or UC San Diego Health in La Jolla, California."

Answered by AI

Who else is applying?

What state do they live in?
New York
California
What site did they apply to?
Mass Eye and Ear
Cedars-Sinai
Columbia University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1

What questions have other patients asked about this trial?

How long does each visit take and what all does it entail in it’s entirety for me to do this?
PatientReceived 1 prior treatment
How long does the trial last? What are you hoping to find? What is the compensation? Are there any locations in Orange County?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I want to help with this trial. Frustrated with all the problems that Thyroid/Hashimoto's has caused over the years.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
2022. "A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05276063.
All > Thyroid
~27 spots leftby Apr 2025
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