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Linsitinib

Clinical trials are investigating Linsitinib in people with active, moderate to severe thyroid eye disease. These studies aim to assess safety, efficacy, and eye-related outcomes such as proptosis, which means eye bulging. The trials include adults with this condition and use placebo comparison in Phase 2 studies.

Table of Contents

Trial overview

Two interventional Phase 2 studies of Linsitinib were listed in the source data, and both were completed.[1][2]

Both trials studied people with active, moderate to severe Thyroid Eye Disease (TED), which is the condition named in the trial records.[1][2]

Who was studied

The first study, NCT05276063, enrolled 18 participants with active, moderate to severe TED.[1]

The second study, 2022-502812-35-00, enrolled 75 subjects with active, moderate to severe TED, and its summary says it included eligible subjects who completed Week 24 of the lead-in study VGN-TED-301.[2]

These trial records do not provide a wider list of entry rules, so the key target population in both studies was people with active, moderate to severe TED.[1][2]

What the trials measured

The main outcome in NCT05276063 was the proptosis responder rate at Week 24, which means the study looked at how many people had an improvement in eye bulging by that time.[1]

In the second study, the main outcome was the proptosis responder rate at Extension study Week 24.[2]

The trial record explains the responder definition as a reduction of at least 2 mm in the primary study eye, without a worsening of at least 2 mm in the other eye.[2]

This endpoint is patient-focused because it measures a visible change in eye bulging, not just a lab result or scan finding.[1][2]

Trial design and comparison groups

Both studies were interventional, meaning participants received a study treatment rather than only being observed.[1][2]

Each record lists Linsitinib and a placebo comparison group, which is a look-alike tablet used to help show whether the study drug performs differently from no active treatment.[1][2]

The records also state that Linsitinib was given by oral use in both studies.[1][2]

Trial status and size

Both trials were marked Completed, so the study periods listed in the source data have ended.[1][2]

The smaller study had 18 participants, while the larger study had 75 participants.[1][2]

Because these are Phase 2 studies with relatively small enrollment, they are mainly designed to explore whether the treatment may help and to gather more data for later research.[1][2]

Key patient terms

Proptosis means eye bulging, which is a common visible problem in TED.[1][2]

Week 24 means the result was measured after 24 weeks of study treatment or follow-up.[1][2]

Extension study means a follow-up part of the research that continues after the main study period.[2]

Lead-in study means an earlier study phase that participants finished before entering the extension study.[2]

Responder rate means the percentage of participants who met the study’s improvement rule.[1][2]

Trial ID Phase Condition studied Status Enrollment Main endpoint
NCT05276063 Phase 2 Active, moderate to severe Thyroid Eye Disease Completed 18 Proptosis responder rate at Week 24
2022-502812-35-00 Phase 2 Active, moderate to severe Thyroid Eye Disease Completed 75 Proptosis responder rate at Extension study Week 24

FAQ

  • What is being studied in the Linsitinib trials? The trials are studying Linsitinib in active, moderate to severe thyroid eye disease. They mainly look at whether the treatment improves eye bulging over time.
  • Who can take part in these studies? The studies include people with active, moderate to severe thyroid eye disease. One trial also focused on eligible subjects who finished Week 24 of a lead-in study.
  • What phase are the Linsitinib trials? Both trials are Phase 2 studies. This phase helps researchers see if a treatment may work and continue checking safety.
  • What outcomes are measured? The main outcome is the proptosis responder rate. This means the number of people who had at least a 2 mm reduction in eye bulging without worsening in the other eye.
  • Are these studies completed? Yes, both trials listed here are completed. They were interventional studies, meaning participants received a study treatment or placebo.

Ongoing Clinical Trials on Linsitinib

  • Study on the Safety and Efficacy of Linsitinib for Patients with Active, Moderate to Severe Thyroid Eye Disease

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

  • Study on Linsitinib for Patients with Active, Moderate to Severe Thyroid Eye Disease

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

Glossary

  • Active disease: A phase of illness where signs and symptoms are still changing or getting worse.
  • Moderate to severe: A description of how serious a disease is. In these studies, it means the eye disease was not mild.
  • Thyroid Eye Disease (TED): An eye condition linked to thyroid disease. It can cause the eyes to bulge and other eye problems.
  • Phase 2: A stage of clinical research that looks more closely at whether a treatment may work and continues safety checks.
  • Interventional study: A study where participants receive a treatment, such as a drug or placebo, so researchers can compare results.
  • Placebo: A look-alike tablet with no active study drug. It helps researchers compare the real treatment against no active treatment.
  • Proptosis: Eye bulging, or the eye sticking out farther than normal.
  • Responder rate: The percentage of people who reach a set improvement goal in a study.
  • Baseline: The starting point before treatment begins. It is used to compare later results.
  • Contralateral non-study eye: The eye on the opposite side that is not being measured as the main study eye.
  • Lead-in study: An earlier study phase that comes before an extension study.
  • Extension study: A follow-up study that continues to collect data after the main study period.

References