Early GLP-1 Receptor Agonist and SGLT2 Inhibitor Add-On Strategies in Adults With Obesity, Type 2 Diabetes, Cardiovascular-Kidney-Metabolic Syndrome Stage 2-3, and Metabolic Dysfunction-Associated Steatotic Liver Disease

This retrospective observational target-trial emulation uses electronic health record data from the TriNetX US Collaborative Network to compare early treatment intensification strategies in adults with obesity, type 2 diabetes, cardiovascular-kidney-metabolic syndrome stage 2-3, and metabolic dysfunction-associated steatotic liver disease who initiate a GLP-1 receptor agonist or an SGLT2 inhibitor as background therapy. Within each background-therapy cohort, patients who added the complementary class within 90 days of initiation were compared against patients who did not, with prespecified comparisons against both the overall non-complementary cohort and the analytical subset who initiated usual-care add-on therapy (DPP-4 inhibitors, sulfonylureas, or insulin) within the same window. The primary outcome is all-cause mortality over 60 months, with major adverse cardiovascular, kidney, and liver outcomes also evaluated. Propensity-score matching is used to reduce bias from nonrandom treatment selection.

NCT Number	NCT07566299
Lead Sponsor	Chung Shan Medical University Collaborators: National Science and Technology Council, Taiwan
Conditions	Obesity Type 2 Diabetes Mellitus, Cardiovascular-kidney-metabolic Syndrome, Metabolic Dysfunction-Associated Steatotic Liver Disease
Enrollment	118,805 participants
Start Date	2017-01-01
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-25