Lilly's orforglipron posts Phase 3 diabetes results; six new trials registered

Lilly's busiest item this week was the posting of completed Phase 3 results for its oral GLP-1 drug, alongside six newly registered or recruiting studies across oncology and obesity.

• Orforglipron (LY3502970), an oral GLP-1 therapy, completed a Phase 3 trial assessing efficacy and safety compared with oral semaglutide in adults with Type 2 diabetes and inadequate glycemic control on metformin, with the study expected to last around 61 weeks¹. The trial enrolled 1698 participants¹ and compared HbA1c changes at week 52 across dose arms.
• Vepugratinib (LY3866288), an oral FGFR3 inhibitor, has a new Phase 2 study called "FORAY," designed to see how well vepugratinib works in adults with low grade, intermediate risk, non-muscle invasive bladder cancer or low-grade upper tract urothelial carcinoma, with safety also assessed². The study is not yet recruiting and plans to enroll 161 participants².
• Selpercatinib (LY3527723), an oral RET inhibitor, has a new Phase 4 study not yet recruiting that will evaluate the safety of selpercatinib in RET-altered cancer patients in India, with each participant expected to be followed for about 56 weeks³.
• Tirzepatide (LY3298176), a GIP/GLP-1 agonist, has a new Phase 3 pediatric obesity trial not yet recruiting, testing the drug against placebo in participants 6 to less than 12 years of age with obesity, added to a healthy lifestyle regimen⁴, with 150 participants estimated for enrollment⁴.
• Abemaciclib (LY2835219), a CDK4/6 inhibitor, has a Phase 1 study now recruiting in healthy volunteers that compares different forms of abemaciclib to measure how much and how fast each is absorbed after oral dosing, and checks for side effects⁵, with an estimated enrollment of 15 participants⁵.
• Tirzepatide is also the subject of a new Phase 3 trial, sponsored by Universidade do Porto with Lilly as collaborator, testing whether the drug helps patients with suboptimal weight loss after bariatric surgery lose more weight and improve overall health⁶. The study is not yet recruiting and plans to randomize 70 participants 1:1 to tirzepatide or matching placebo⁶.
• A GRPR-targeted PET imaging agent, [⁶⁸Ga]-LY4257529, is the subject of a new early-phase imaging study sponsored by Jewish General Hospital with Lilly as collaborator, which plans to enroll up to 60 participants in two cohorts, 30 with breast cancer and 30 with other selected GRPR-expressing malignancies⁷. The study is not yet recruiting.