Linsitinib for Thyroid Eye Disease
(ORBIT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an investigational oral treatment called linsitinib for people with moderate to severe active Thyroid Eye Disease (TED), a condition linked to autoimmune thyroid disease that causes swelling, discomfort, and bulging of the eyes. As a Phase 3 trial, this study is designed to confirm how well linsitinib works and to continue monitoring its safety in a larger group of people.
Do I need to stop my current medications for the trial?
Some medications can be continued and others will need to be stopped. It's best to discuss this with the study doctor to understand how your medications might interact with the trial.
Is there any evidence suggesting that linsitinib is likely to be safe for humans?
Linsitinib has been studied in earlier research, including trials involving more than 800 people in a different disease area, which provided information about how the drug affects the body. It has also been evaluated in an earlier-phase study in people with Thyroid Eye Disease. Because linsitinib is still investigational and is not approved for use in any country, its full range of effects and side effects is not yet known. This Phase 3 trial is being conducted to learn more about the safety of linsitinib in people with Thyroid Eye Disease, and participants will be monitored closely throughout the study.
Why do researchers think this study treatment might be promising for Thyroid Eye Disease?
Linsitinib is designed to block a signal called the IGF-1 receptor that plays a key role in driving the eye changes in TED. Blocking this same IGF-1 receptor pathway is the basis for an existing approved TED therapy. Researchers are especially interested in linsitinib because it is taken as a simple oral pill rather than an infusion, which could make treatment easier for patients.
Are You a Good Fit for This Trial?
Adults aged 18 and older with Thyroid Eye Disease linked to Graves' disease and/or Hashimoto's thyroiditis may be able to join. Eligible participants have moderate to severe, active eye disease that was diagnosed within about the last 15 months and has a noticeable impact on daily life.They must be willing to sign the consent form and follow the study plan.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial.
Treatment
Participants will receive either Linsitinib or a placebo treatment.
Follow-up
Participants are monitored for safety after treatment. Certain participants may be eligible to further receive the investigational drug through an open-label extension
What Are the Treatments Tested in This Trial?
Interventions
- Linsitinib
Trial Overview
This study is testing linsitinib, an oral pill, as a possible treatment for Thyroid Eye Disease (TED). Participants will take either linsitinib or a placebo (an identical-looking pill with no active medicine) so the two can be compared. The pills are taken twice a day, about 12 hours apart, with food and a glass of water, for 24 weeks. Researchers will track how participants' eyes and overall health respond over the course of the study to understand how well linsitinib works and how safe it is.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sling Therapeutics, Inc.
Lead Sponsor
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