NCT07566299Completed
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
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: A Target Trial Emulation
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 118805 (actual)
- First submitted
- 26 Apr 2026
- Start date
- 1 Jan 2017
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Chung Shan Medical University
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07566299
What you commit to
- Study type: Observational
- Participants enrolled: 118805
- From 1 Jan 2017 to the primary completion date, 31 Mar 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior bariatric surgery
- Prior solid-organ transplantation
- Hepatocellular carcinoma or liver transplant within 1 year before background therapy initiation
- Major cardiovascular, kidney, or liver event within the 6-month window before background therapy initiation
- Transplant-related complications
Other illness
- Type 1 diabetes mellitus, or other specified diabetes types that are not type 2 diabetes
- Human immunodeficiency virus infection
- Other chronic, alcohol-related, or secondary liver diseases
Who the study is looking for
- Adults aged 18 years or older.
- BMI ≥27 kg/m², or diagnosis codes consistent with obesity
- Type 2 diabetes mellitus
- Cardiovascular-kidney-metabolic syndrome stage 2-3
- Metabolic dysfunction-associated steatotic liver disease
- New initiation of GLP-1 receptor agonist therapy or SGLT2 inhibitor therapy during the study period as background therapy
- No prescription of either GLP-1 receptor agonist or SGLT2 inhibitor within the 6-month washout window before background therapy initiation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.