Lilly posts galunisertib PFS results in prostate cancer; registers new bimagrumab HFpEF trial

Lilly's registry activity included one results posting from a collaborator-sponsored trial and a new Phase 2 heart failure study, alongside previously noted postings.

• A Phase 2 trial testing galunisertib (LY2157299) plus enzalutamide against enzalutamide alone in metastatic castration-resistant prostate cancer posted results. The study is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, with Eli Lilly and Company and National Capital Foundation as collaborators¹. Median progression-free survival was 5.6 months for enzalutamide with LY2157299 versus 7.3 months for enzalutamide alone, with serious adverse events in 5 of 37 participants in the combination arm versus 8 of 23 in the enzalutamide-alone arm¹.
• A new Phase 2 study called "ACTIVATE-HFpEF" will compare bimagrumab against placebo in patients with heart failure with preserved ejection fraction. The trial is designed with an estimated enrollment of 540 participants² and is not yet recruiting, with the primary outcome measuring change from baseline in the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score at Week 52².
• A Phase 1 study will compare test and reference formulations of imlunestrant (LY3484356) and examine the effects of food and omeprazole on its pharmacokinetics³ in healthy female participants. The trial has an estimated enrollment of 343 participants³ and is not yet recruiting.
• A Phase 3 trial called "AMPLIFY-2" will compare a coformulation of eloralintide and tirzepatide (EloraTZP) against tirzepatide alone for body weight reduction in participants with obesity or overweight and type 2 diabetes⁴. The study has an estimated enrollment of 1000 participants⁴ and is recruiting.
• A Phase 1 study of LY4247147 in people with obesity or overweight who are otherwise healthy is not yet recruiting, with an estimated enrollment of 108 participants⁵ across three parts.
• A Phase 1 pharmacokinetic study of lepodisiran (LY3819469) in healthy participants with high lipoprotein(a) is not yet recruiting. The trial will evaluate how the body takes in lepodisiran after a single injection under the skin and compare how much lepodisiran gets into the body from each injection site⁶, with an estimated enrollment of 66 participants⁶.
• The Phase 1 single- and multiple-ascending dose study of oral LY3867070 in healthy participants has reached completed status, with an enrollment of 141 participants⁷ and both primary and study completion listed as actual on 2026-09-30.