Boehringer Ingelheim USA Corporation

FIBRONEER™-IPF trial met primary endpoint: absolute change in Forced Vital Capacity at week 52. Boehringer Ingelheim to submit nerandomilast for IPF treatment to FDA and other Health Authorities worldwide.

Boehringer Ingelheim seeks regulatory approval for nerandomilast after its Phase III FIBRONEER-IPF trial met primary endpoint in idiopathic pulmonary fibrosis, improving forced vital capacity. The company plans to present full data in 2025. Nerandomilast, a PDE4B inhibitor, received breakthrough therapy designation in 2022 and is also being tested in progressive fibrosing interstitial lung diseases.

GLP-1 meds like Ozempic reduce risk of cirrhosis and death in diabetes patients with metabolic dysfunction-associated steatotic liver disease (MASLD), according to a study in JAMA Internal Medicine. Semaglutide (Ozempic/Wegovy) was particularly effective if taken early in MASLD progression. GLP-1s work by reducing body weight, blood sugar, and inflammation, potentially reversing fatty liver disease.

A multinational clinical trial, EASi-KIDNEY, will evaluate whether vicadrostat (BI 690517) combined with empagliflozin reduces CKD progression, heart failure hospitalization, or cardiovascular death. The trial, involving 11,000 participants across 15-20 countries, aims to provide robust evidence for new treatments. Initial results are expected by 2028/2029.

Various researchers report financial relationships with pharmaceutical companies, including Deciphera, during and outside the conduct of the study.

A.A. (UCSF, NIH T32 grant, past consulting income from LeMaitre and MIS Technologies) and D.R. (FDA) have no conflicts of interest. L.H.C. (Duke, FDA, past consulting income from Regeneron, NFLPA, Boehringer, institutional grants from GSK, Novartis) also has no conflicts. R.M.C. (FDA, former Verily Life Sciences, Google Health employee, held equity, served on boards of Cytokinetics, Centessa, Clinetic, Keystone Symposia, C-Path, Clinical Research Forum, One Fifteen) discloses no conflicts related to this manuscript.

At EASD 2024, Boehringer Ingelheim's survodutide, a GCGR/GLP-1R dual agonist, showed 40% of overweight/obese patients achieved >20% weight loss after 46 weeks, with no plateau. For MASH, it reduced blood pressure significantly. Safety concerns were due to rapid dose escalation, which could be mitigated by gradual escalation. No direct correlation between amino acid levels and muscle loss was found. Key opinion leaders find a GCGR/GLP-1R dual agonist desirable for weight, glucose, and blood pressure reduction, improving lipids, and sustaining metabolic rate.