Linsitinib for Thyroid Eye Disease

(LIDS Trial)

Recruiting at 35 trial locations

Overseen By Cathy Radovich

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: VasaraGen, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial studies the safety and effectiveness of linsitinib, an oral medication taken regularly, in patients with moderate to severe thyroid eye disease. Linsitinib works by blocking a protein that contributes to the disease, aiming to reduce symptoms and improve eye health.

Eligibility Criteria

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.

Inclusion Criteria

I have Graves' Disease or Hashimoto's with severe thyroid eye disease.

I don't need eye surgery or treatment now or during the study.

I don't need eye surgery or treatment now or during the study.

Exclusion Criteria

My eye condition has not improved with medication.

I have previously been treated with an IGF-1R inhibitor.

Treatment Details

Interventions

• Linsitinib (Small Molecule Inhibitor)
• Placebo (Drug)

Trial Overview 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.

Participant Groups

Group I: Low Dose Active Control 1 Intervention

Active Arm Low Dose Linsitinib

Group II: High Dose Active Control 1 Intervention

Active Arm High Dose Linsitinib

Group III: Placebo Placebo Group 1 Intervention

Placebo Arm

Who Is Running the Clinical Trial?

VasaraGen, Inc.

Lead Sponsor

Trials

1

Recruited

90+

Sling Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

170+