Recruiting
Phase 2
Phase 3

Linsitinib

Sponsor:

Sling Therapeutics, Inc.

Code:

NCT06112340

Conditions

Thyroid Eye Disease

Graves Orbitopathy

Endocrine System Diseases

Eye Diseases

Thyroid Associated Ophthalmopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

linsitinib

Study Details

Brief summary:

The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.

Conditions

Thyroid Eye Disease

Graves Orbitopathy

Endocrine System Diseases

Eye Diseases

Thyroid Associated Ophthalmopathy

Study ID

NCT06112340

Start date

Oct 11, 2023

Status verified date

Feb, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject who completed the 24-week double-mask period of VGN-TED-301 and are proptosis non-responders (< 2 mm reduction in proptosis in the study eye) at Week 24 of VGN-TED-301 study or proptosis responders at Week 24 who relapse during the Follow-Up period of VGN-TED-301
  • Subject has not received any treatment for TED since Week 24 of VGN-TED-301
  • Subjects must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine \[FT4\] and free triiodothyronine levels \[FT3\] <50% above or below the normal limits) at Baseline. Every effort should be made to correct mild hypo- or hyperthyroidism promptly and maintain the euthyroid state for the duration of the clinical trial
  • Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Baseline and is not planning for any such treatment during the course of the study

Exclusion Criteria:

  • The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Low Dose

Active Arm Low Dose Linsitinib

active comparator: High Dose

Active Arm High Dose Linsitinib

Interventions

linsitinib

Study medication taken twice daily by mouth

Primary outcome measure

  • Percentage of Subjects who are Proptosis Responders at Week 24 [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Cathy Radovich

734-887-9192info@slingtx.com

Robin Schmidt

734-887-9192info@slingtx.com

Locations

Bascom Palmer Eye Institute

Recruiting

Miami, Florida, United States, 33136

Contacts

Jennifer Gomez

jxg1540@miami.edu

West Virginia University Eye Institute

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Athena Echols

athena.sparks@wvumedicine.org

More Information

Sponsor

Sling Therapeutics, Inc.

Last update posted

Feb 25, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sling Therapeutics, Inc. on 2025-02-25.