Abstract: FR-PO0487
Formoterol as a Treatment for Diabetic Nephropathy (and Metabolic Dysfunction-Associated Steatohepatitis): A New Clinical Trial
Session Information
- CKM: Clinical - Trials, Epidemiology, and Biomarkers
October 23, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Cardiovascular-Kidney-Metabolic Health
- 602 Cardiovascular-Kidney-Metabolic Health: Clinical
Authors
- Winkler, Brennan, Medical University of South Carolina, Charleston, South Carolina, United States
- Lipschutz, Joshua H., Medical University of South Carolina, Charleston, South Carolina, United States
Background
Diabetes mellitus (DM) is estimated to affect 828 million people. Diabetic nephropathy (DN) and metabolic associated steatohepatitis (MASH) are highly prevalent in patients with diabetes. There is an urgent need for new therapeutics for DN and MASH as current treatments slow but do not reverse DN and there are only two moderately effective FDA-approved treatments for MASH. We studied the effects of a beta-2 adrenergic receptor (b2AR) agonist, formoterol, in DN and MASH. We showed that, in type 1 and 2 mouse models of DM, formoterol reversed DN at the histological, ultrastructural, and functional levels. In a retrospective study of 24,133 Veterans with stage 4 CKD, b2AR agonists were associated with a 33.2% reduction in progression to end-stage kidney disease (ESKD) with long-acting formoterol and a 20.8% reduction in ESKD with short-acting b2-AR agonists (Arif et al., Am J Physiol, Renal Physiol, 2024). We also showed that formoterol reduced the lipid burden in the livers of mice fed a high fat diet. A retrospective analysis of 59,644 patients with MASH showed that patients taking long-acting b2AR agonists like formoterol had fewer complications of advanced liver disease and 35% lower all-cause mortality (Winkler et al., (npj) Metab Health and Dis, 2026). The mechanism in both cases was increased mitochondrial biogenesis. These data led us to initiate a clinical trial (ClinicalTrials.gov Identifier: NCT07022418).
Methods
We initiated a prospective randomized trial to enroll 120 subjects with type 2 DM, CKD stage 2-3 secondary to DN, and albuminuria 200-5,000 mg/g. Given the high incidence of MASH, we will also be able to study the role of formoterol in MASH. Formoterol will be randomly assigned as shown in the figure. The primary outcome is changes in albuminuria between groups from baseline to the end of the study. Secondary outcomes will be changes in safety, intervention acceptability, eGFR, Fibrosis 4 (FIB-4), and liver elastography.
Results
TBD
Conclusion
If this trial supports the hypothesis that formoterol attenuates DN and MASH in diabetic patients, this would represent a major advance as formoterol has an excellent safety profile and is inexpensive.
Funding
- Veterans Affairs Support – Dialysis Clinic, Inc.