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Active not recruiting

Comparative Effectiveness of Tirzepatide vs Semaglutide in Participants With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction

Assets

Semaglutide / Tirzepatide

Listed sites

1

Recruiting sites

Enrollment

26,000

estimated

Study population

Heart failure, Type 2 diabetes

Key I/E criterion

Primary endpoint

Expanded / custom MACE composite (Heart-failure hospitalization, 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 IDNCT06980623
Org study ID2024P001317-2

Timeline

Milestones

Study start2025-01-01actual
Study first posted2025-05-20actual
Primary completion2025-11-30actual
Last update posted2026-05-15actual
Study completion2026-10-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Heart failureType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Sampling methodNon probability sample

Study population text

Patients \> 18 years old with T2D and HFpEF.

Inclusion criteria

Patients who are new users of tirzepatide or new users of semaglutide
Patients with diagnosis of T2D and HFpEF, i.e., EF >= 45%.
Age >= 18 years old
Patients with continuous health plan enrollment before and including the treatment initiation date

Exclusion criteria

Patients with missing age or sex information
Patients with type 1 diabetes mellitus, secondary or gestational diabetes
History of diabetes related complications
Patients with related chronic diseases.
History of gastrointestinal conditions.
Previous exposure to other GLP-1RA and pramlintide
Patients with prescription dispensing for both tirzepatide and semaglutide on cohort entry date

Endpoints (1)

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.

Cardiovascular outcomes

1 endpoint
Primary/protocol endpoint

Hospitalization for heart failure and all-cause mortality

Time frame:From treatment initiation to end of follow up, up to 48 months.

Expanded / custom MACE composite

composite event, event

componentsHeart-failure hospitalization, All-cause death

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.