Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)

Conditions

• Graves Orbitopathy
• Thyroid Eye Disease, TED

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• linsitinib — DRUG
  150 mg linsitinib is taken twice daily by mouth for 24 weeks
• Placebo — DRUG
  0 mg placebo taken twice daily by mouth for 24 weeks

Study Details

The goal of this clinical trial is to evaluate the efficacy, safety, and tolerability of linsitinib in participants with moderate to severe Thyroid Eye Disease (TED).

Key Dates

First listed

Aug 7, 2026

Start date

Aug 4, 2026

Status verified

Aug 2026

Primary completion

Jun 30, 2028

Completion

Jun 28, 2030

Study Design

Enrollment

130 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Double-mask Treatment Arm
  Participants receive linsitinib 150 mg twice daily for 24 weeks.
• Placebo Comparator: Double-mask Placebo Arm
  Participants receive placebo 0 mg twice daily for 24 weeks.
• Experimental: Open-label Extension Treatment Arm
  Proptosis non-responders/relapsed proptosis responders receive linsitinib 150 mg twice daily for 24 weeks.

Primary Outcome Measure

Measure percentage of participants who are Proptosis Responders at Week 24 [ Time Frame: 24 weeks ]

Central Contacts

• Cathy Radovich
  (734) 223-1786
  [email protected]

Locations (1)

Find similar trials in Las Vegas, NV

Related Studies

• Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
  PHASE2/PHASE3 · Recruiting · Sling Therapeutics, Inc. · Miami, Florida