Sling Therapeutics, Inc. announced the first patients have been dosed in the global phase 3 ORBIT pivotal trial. The randomized, double-masked, placebo-controlled study is 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), the company said in a press release.

According to Sling Therapeutics, 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, and the Graves’ Ophthalmopathy Quality of Life questionnaire. Following the 24-week double-masked placebo-controlled treatment period, patients will be eligible to enroll in a 24-week open-label extension, the company said in the press release.