In short
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.
Key points
- Linsitinib is being studied in clinical trials for active, moderate to severe thyroid eye disease. Both trials in the source data are Phase 2 and were completed. The studies compare Linsitinib with placebo and focus on eye bulging, also called proptosis. One trial enrolled 18 people, and the other enrolled 75 eligible subjects from a lead-in study. The main endpoint in both studies is the proptosis responder rate at Week 24. These trials help show whether Linsitinib may improve eye symptoms in this patient group.
Trial overview
Two interventional Phase 2 studies of Linsitinib were listed in the source data, and both were completed.
Both trials studied people with active, moderate to severe Thyroid Eye Disease (TED), which is the condition named in the trial records.
Who was studied
The first study, NCT05276063, enrolled 18 participants with active, moderate to severe TED.
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.
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.
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.
In the second study, the main outcome was the proptosis responder rate at Extension study Week 24.
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.
This endpoint is patient-focused because it measures a visible change in eye bulging, not just a lab result or scan finding.
Trial design and comparison groups
Both studies were interventional, meaning participants received a study treatment rather than only being observed.
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.
The records also state that Linsitinib was given by oral use in both studies.
Trial status and size
Both trials were marked Completed, so the study periods listed in the source data have ended.
The smaller study had 18 participants, while the larger study had 75 participants.
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.
Key patient terms
Proptosis means eye bulging, which is a common visible problem in TED.
Week 24 means the result was measured after 24 weeks of study treatment or follow-up.
Extension study means a follow-up part of the research that continues after the main study period.
Lead-in study means an earlier study phase that participants finished before entering the extension study.
Responder rate means the percentage of participants who met the study’s improvement rule.