DASH-CKMH

Active not recruiting

Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)

Lead sponsor

Ohio State University

Assets

Albiglutide / Dulaglutide / Exenatide / Liraglutide / Lixisenatide / Semaglutide / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

23,280,000

estimated

Study population

Metabolic syndrome

Key I/E criterion

—

Primary endpoint

•Expanded / custom MACE composite (Non-fatal MI, Non-fatal stroke, Cardiovascular death)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07188545

Org study IDSTUDY20250372

Timeline

Milestones

Study start2025-09-15actual

Study first posted2025-09-23actual

Last update posted2025-09-23actual

Primary completion2029-06-30estimated

Study completion2029-06-30estimated

Assets

Investigational agents

Albiglutide Dulaglutide Exenatide Liraglutide Lixisenatide Semaglutide Tirzepatide

Study populations

Who this study enrolls

Metabolic syndrome

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

The data for this study comes from claims and electronic health records data sources. MarketScan and All of Us are nationally representative databases, and therefore contain patients from all over the US. LifeScale is a local database from The Ohio State University Wexner Medical Center (OSUWMC) and contains patients who seek care at OSUWMC inpatient and outpatient facilities. Adult patients included in the study have evidence of CKMS stage 1 or 2, ≥1 prescription for a GLP-1RA, SGLT2i, DPP4i, or obesity medication, and at least 180 days of continuous database enrollment prior to the first prescription for any medication of interest. Patients will be excluded if they have evidence of stage 3 or 4 CKMS, cancer, renal replacement therapy, end stage renal disease, or solid organ transplant during the baseline period (180 days prior to index date), any history of type I diabetes, or missing sex information. These study criteria will be applied to each of the sources of secondary data to co

Inclusion criteria

•Stage 1 or 2 CKMS at baseline

•At least one prescription for an intervention or comparator medication after CKMS diagnosis

•At least 180 days of continuous enrollment prior to the first prescription for any medication of interest (index date)

•Age 18+ at index date

Exclusion criteria

•Stage 3 or 4 CKMS at baseline

•Medications of interest during baseline period

•Any history of type I diabetes

•Cancer at baseline

•Renal replacement therapy at baseline

•End stage renal disease at baseline

•Solid organ transplant at baseline

•Missing sex

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes

Renal / kidney

Heart failure

Other (unclassified)

Cardiovascular outcomes

7 endpoints

Primary/protocol endpoint

3-Point major adverse cardiovascular event (3P-MACE)

Time frame:Up to 5 years

Expanded / custom MACE composite

composite event, event

componentsNon-fatal MI, Non-fatal stroke, Cardiovascular death

Secondary/protocol endpoint

All-cause Mortality

Time frame:Up to 5 years

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

stroke

Time frame:up to 5 years

Stroke (any)

time to event, event

SNOMED 230690007

Secondary/protocol endpoint

Myocardial Infarction

Time frame:up to 5 years

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Secondary/protocol endpoint

Incident coronary heart disease diagnosis

Time frame:up to 5 years

time to event, event

Secondary/protocol endpoint/low confidence

Incident peripheral artery disease diagnosis

Time frame:up to 5 years

time to event, event

Secondary/protocol endpoint

Atrial fibrillation diagnosis

Time frame:up to 5 years

Atrial-fibrillation composite

categorical status, event

Heart failure

1 endpoint

Secondary/protocol endpoint/low confidence

heart failure

Time frame:up to 5 years

descriptive

SNOMED 84114007

Renal / kidney

3 endpoints

Secondary/protocol endpoint

renal failure

Time frame:up to 5 years

End-stage renal disease

time to event, event

SNOMED 46177005

Secondary/protocol endpoint

kidney transplant

Time frame:up to 5 years

Kidney-replacement therapy

time to event, event

Secondary/protocol endpoint

kidney dialysis

Time frame:up to 5 years

Kidney-replacement therapy

time to event, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Advancing CKMS stage

Time frame:Up to 5 Years

categorical status, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.