Lilly registers four new trials: Alzheimer's, cardiovascular, obesity, Crohn's programs

Four new trial registrations tied to Eli Lilly appeared this week, three company-sponsored and one investigator-led with Lilly as collaborator.

• A Phase 1 master protocol (NCT07787169) will evaluate LY4405094, an amyloid-targeting therapy, in both healthy volunteers and people with Alzheimer's disease. The study is not yet recruiting and plans to enroll 179 participants.¹
• A related Phase 1 study (NCT07787182) will test LY4405094 for safety, tolerability, and pharmacokinetics in the same two populations. It is not yet recruiting and plans to enroll 68 participants,² with a primary outcome tracking serious adverse events tied to study drug administration.
• A Phase 2b trial called "CLARITY-CRP" (NCT07783802) will test clazakizumab, an IL-6 inhibiting antibody, for lowering hsCRP levels in adults at elevated cardiovascular risk. The study is recruiting and plans to enroll 120 participants,³ with the primary outcome tracking percent change in hsCRP at Week 12.
• A Phase 3 trial called "ATTAIN-CN" (NCT07790861) will test oral orforglipron against placebo in Chinese adults with obesity or overweight who have weight-related health problems. The study is not yet recruiting and plans to enroll 192 participants,⁴ with the primary outcome measured as mean percent change in body weight at Week 48.
• A Phase 4 study called "MIRICURE" (NCT07782021) will evaluate mirikizumab combined with surgical curettage and closure in patients with perianal fistulizing Crohn's disease. The trial is sponsored by the Icahn School of Medicine at Mount Sinai, with Eli Lilly and Company and Washington University School of Medicine as collaborators.⁵ It is not yet recruiting and will enroll approximately 50 adults with active complex perianal fistulizing Crohn disease,⁵ with the primary endpoint assessing combined clinical remission and radiologic response at Week 24.