Sling is currently enrolling patients in the pivotal Phase 3 ORBIT trial, a randomized, double-masked, placebo-controlled study evaluating the efficacy and safety of linsitinib, an oral small molecule inhibitor of the insulin-like growth factor-1 receptor (IGF-1R), in adults with moderate to severe active thyroid eye disease (TED).
ORBIT is expected to enroll approximately 130 participants, randomized 1:1 to receive oral linsitinib 150 mg or placebo twice daily for 24 weeks. The primary endpoint is the proportion of proptosis responders at Week 24, defined as participants achieving a reduction of at least 2 mm in proptosis in the study eye without a corresponding worsening in the fellow eye. Secondary endpoints include mean change from baseline in proptosis, overall responder rate, Clinical Activity Score (CAS), and the Graves’ Ophthalmopathy Quality of Life (GO-QoL) questionnaire. Following the 24-week double-masked placebo-controlled treatment period, patients will be eligible to enroll in a 24-week open-label extension.
To learn more about the ORBIT clinical trial, including participating sites and eligibility criteria, visit ClinicalTrials.gov (identifier: NCT07753603).
Note: Linsitinib is not approved as a marketed product at this time. Clinical trials are required by the U.S. Food and Drug Administration (FDA) to demonstrate the safety and efficacy of a potential medication before general availability.