Lilly posts orforglipron Phase 3 results; adds new early-phase studies

This week brought Phase 3 obesity results alongside several newly registered or updated early-stage trials across Lilly's pipeline.

• Results for "ATTAIN-1" (NCT05869903), a Phase 3, randomized, double-blind study of once-daily oral orforglipron versus placebo in adult participants with obesity or overweight with weight-related comorbidities¹, were posted this week. The trial enrolled 3127 participants¹ and measured percent change from baseline in body weight through Week 72 as the primary outcome¹.
• A new Phase 1 study of LY4355756 (NCT07765498) in healthy participants is listed as recruiting, with the purpose of assessing how LY4355756 is absorbed by the body and how safe it is in healthy participants². The study has an estimated enrollment of 123 participants² at a single site in Dallas, Texas.
• A Phase 1 study of macupatide (LY3532226), Lilly's obesity drug, is not yet recruiting. The study will assess how well macupatide, when dosed alone and in combination with eloralintide, is tolerated and what side effects may occur in participants with obesity or overweight without Type 2 diabetes³, with an estimated enrollment of 60 participants³.
• The Phase 2 brenipatide (LY3537031) COPD trial, "RENEW-COPD" (NCT07759245), is listed as recruiting, with a design to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease, when compared with placebo⁴. The study has an estimated enrollment of 606 participants⁴.
• A university-sponsored Phase 4 study of tirzepatide (Zepbound) for chronic high bowel frequency after ileal pouch-anal anastomosis, "PROP-ZEP" (NCT07756359), is not yet recruiting; Eli Lilly is a collaborator, with the University of North Carolina, Chapel Hill as lead sponsor⁵. The trial will test whether Tirzepatide (Zepbound) can decrease bowel frequency in patients that have an ileal-pouch anal anastomosis better than standard of care anti-diarrheal therapy⁵, with an estimated enrollment of 20 participants⁵.
• Results were also posted for a terminated pediatric COVID-19 study of baricitinib (LY3009104), NCT05074420, which was terminated due to an inability to enroll participants⁶, with final enrollment of 6 participants⁶.