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

NCT07566299 | Completed Results

• 1 other identifier: CS1-26035
• Study Type: observational
• Target: 118,805
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity Type 2 Diabetes Mellitus; Cardiovascular-kidney-metabolic Syndrome; Metabolic Dysfunction-Associated Steatotic Liver Disease

Outcome Measures

Primary Outcomes (4)

• All-cause Mortality (Comparison 1)

  All-cause mortality from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 1, comparing adults with obesity, type 2 diabetes, CKM syndrome stage 2-3, and MASLD who initiated GLP-1 RA therapy with early SGLT2i add-on versus those who initiated GLP-1 RA therapy without early SGLT2i add-on (monotherapy).

  From 90 days after treatment initiation through up to 60 months of follow-up

• All-cause Mortality (Comparison 2)

  All-cause mortality from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 2, comparing adults with obesity, type 2 diabetes, CKM syndrome stage 2-3, and MASLD who initiated GLP-1 RA therapy with early SGLT2i add-on versus those who initiated GLP-1 RA therapy with usual care (DPP-4 inhibitor, sulfonylurea, or insulin add-on).

  From 90 days after treatment initiation through up to 60 months of follow-up

• All-cause Mortality (Comparison 3)

  All-cause mortality from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 3, comparing adults with obesity, type 2 diabetes, CKM syndrome stage 2-3, and MASLD who initiated SGLT2i therapy with early GLP-1 RA add-on versus those who initiated SGLT2i therapy without early GLP-1 RA add-on (monotherapy).

  From 90 days after treatment initiation through up to 60 months of follow-up

• All-cause Mortality (Comparison 4)

  All-cause mortality from the 90-day landmark date through up to 60 months of follow-up in the propensity score-matched cohort for Comparison 4, comparing adults with obesity, type 2 diabetes, CKM syndrome stage 2-3, and MASLD who initiated SGLT2i therapy with early GLP-1 RA add-on versus those who initiated SGLT2i therapy with usual care (DPP-4 inhibitor, sulfonylurea, or insulin add-on).

  From 90 days after treatment initiation through up to 60 months of follow-up

Secondary Outcomes (12)

• Major Adverse Cardiovascular Events (Comparison 1)

  From 90 days after treatment initiation through up to 60 months of follow-up

• Major Adverse Cardiovascular Events (Comparison 2)

  From 90 days after treatment initiation through up to 60 months of follow-up

• Major Adverse Cardiovascular Events (Comparison 3)

  From 90 days after treatment initiation through up to 60 months of follow-up

• Major Adverse Cardiovascular Events (Comparison 4)

  From 90 days after treatment initiation through up to 60 months of follow-up

• Major Adverse Kidney Events (Comparison 1)

  From 90 days after treatment initiation through up to 60 months of follow-up

Study Arms (4)

GLP-1 RA with SGLT2i Add-On

Adults with obesity, type 2 diabetes, cardiovascular-kidney-metabolic syndrome stage 2-3, and metabolic dysfunction-associated steatotic liver disease who initiated GLP-1 receptor agonist therapy and added an SGLT2 inhibitor within 90 days after treatment initiation.

GLP-1 RA monotherapy

Adults with obesity, type 2 diabetes, cardiovascular-kidney-metabolic syndrome stage 2-3, and metabolic dysfunction-associated steatotic liver disease who initiated GLP-1 receptor agonist therapy and did not receive early add-on therapy with an SGLT2 inhibitor within 90 days after treatment initiation.

SGLT2i with GLP-1 RA Add-On

Adults with obesity, type 2 diabetes, cardiovascular-kidney-metabolic syndrome stage 2-3, and metabolic dysfunction-associated steatotic liver disease who initiated SGLT2 inhibitor therapy and added a GLP-1 receptor agonist within 90 days after treatment initiation.

SGLT2i monotherapy

Adults with obesity, type 2 diabetes, cardiovascular-kidney-metabolic syndrome stage 2-3, and metabolic dysfunction-associated steatotic liver disease who initiated SGLT2 inhibitor therapy and did not receive early add-on therapy with a GLP-1 receptor agonist within 90 days after treatment initiation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults will be selected from the TriNetX US Collaborative Network, a distributed database of de-identified electronic health records contributed by participating healthcare organizations across multiple clinical systems and practice settings. The study population consists of adults with obesity, type 2 diabetes, cardiovascular-kidney-metabolic syndrome stage 2-3, and metabolic dysfunction-associated steatotic liver disease who received routine clinical care in this network and were identified through diagnosis records, body mass index data, laboratory data, and medication prescribing data. Four mutually exclusive cohorts were defined by background therapy (GLP-1 receptor agonist or SGLT2 inhibitor) and 90-day add-on status, supporting four prespecified pairwise comparisons of early complementary add-on against monotherapy or against usual-care add-on (DPP-4 inhibitor, sulfonylurea, or insulin).

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chung Shan Medical University: lead
• National Science and Technology Council, Taiwan: collaborator

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Limitations and Caveats

As a retrospective observational study using routinely collected electronic health record data, this analysis may be subject to residual confounding, exposure and outcome misclassification, and incomplete capture of clinical variables. The 90-day landmark design excludes early outcome events. MASLD and CKM stage 2-3 definitions depend on diagnosis coding and available laboratory data. Observed associations should not be interpreted as evidence of a treatment effect.

Results Point of Contact

• Title: Yu-Nan Huang, Ph.D.
• Organization: Chung Shan Medical University Hospital

yunanhuang83@gmail.com

886-4-24739595

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor/Research Fellow

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 5, 2026
• Study Start: January 1, 2017
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 25, 2026
• Results First Posted: June 25, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)