DelfaGLP-1 Atlas

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Not yet recruiting

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

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

—

Enrollment

118,805

estimated

Study population

MASH / NAFLD / liver fibrosis, Metabolic syndrome, Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≥27

Primary endpoint

•All-cause 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 IDNCT07566299
Org study IDCS1-26035

Timeline

Milestones

Study first posted2026-05-05actual
Last update posted2026-05-05actual
Study start2026-05-31estimated
Primary completion2026-06-30estimated
Study completion2026-06-30estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisMetabolic syndromeObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

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. Comparator-specific cohorts were defined within this source population to evaluate early GLP-1 receptor agonist- and SGLT2 inhibitor-based treatment strategies.

Inclusion criteria

•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
•Initiation of GLP-1 receptor agonist therapy or SGLT2 inhibitor therapy during the study period

Exclusion criteria

•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

Endpoints (4)

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
2
MASH / liver
1
Renal / kidney
1

Cardiovascular outcomes

2 endpoints
Primary/protocol endpoint

All-cause mortality

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

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Major Adverse Cardiovascular Events

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

Expanded / custom MACE composite

time to event, event

MASH / liver

1 endpoint
Secondary/protocol endpoint/low confidence

Major Adverse Liver Outcomes

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

time to event, event

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Major Adverse Kidney Events

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

Custom renal composite

composite event, event

Publications (34)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.