DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06914141

DUP-TIRZSEMA

Completed

Comparative Effectiveness of Tirzepatide Versus Semaglutide in Individuals With Heart Failure With Preserved Ejection Fraction

Assets

Semaglutide / Tirzepatide

Listed sites

1

Recruiting sites

—

Enrollment

28,118

actual

Study population

Heart failure, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•EF ≥45%

Primary endpoint

•Expanded / custom MACE composite (All-cause death, Heart-failure hospitalization)

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 IDNCT06914141
Org study ID2018P002966-DUP-TIRZSEMA

Timeline

Milestones

Study start2025-01-14actual
Study first posted2025-04-06actual
Primary completion2025-06-01actual
Study completion2025-06-01actual
Last update posted2026-01-30actual

Assets

Investigational agents

SemaglutideTirzepatide

Study populations

Who this study enrolls

Heart failureObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

The study population includes individuals aged 40 years or older with heart failure with preserved ejection fraction.

Inclusion criteria

Eligible cohort entry dates:

Optum: Study period between May 13, 2022 to November 30, 2024. Marketscan: Study period between May 13, 2022 to December 31, 2023.

Inclusion Criteria:

•Heart failure
•BMI > 27.0 kg/m2
•History of type 2 diabetes mellitus
•LVEF ≥ 45%
•≥ 18 years old, male or female sex

Exclusion criteria

•Prior treatment with any GLP-1-RA
•History of type 1 diabetes mellitus
•End-stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis
•History of bariatric surgery
•History of nursing home admission
•Pregnant female or breastfeeding
•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy
•Treatment with continuous subcutaneous insulin infusion
•Multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
•Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) for less than 5 years

Endpoints (11)

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
3
Heart failure
3
Safety / tolerability / PK
3
Other clinical outcomes
2

Cardiovascular outcomes

3 endpoints
Primary/protocol endpoint

Composite of all-cause mortality or heart failure hospitalization

Time frame:Through study completion (1 day after cohort entry date until the first of outcome or censoring)

Expanded / custom MACE composite

time to event, event

componentsAll-cause death, Heart-failure hospitalization

Secondary/protocol endpoint

Composite of all-cause mortality or all-cause mortality or a worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization, intravenous diuretic therapy in an urgent care setting).

Time frame:Through study completion (1 day after cohort entry date until the first of outcome or censoring)

Expanded / custom MACE composite

time to event, event

componentsAll-cause death, Heart-failure hospitalization, Urgent heart-failure visit

Secondary/protocol endpoint

All-cause mortality

Time frame:Through study completion (1 day after cohort entry date until the first of outcome or censoring)

All-cause death

time to event, event

SNOMED 419620001

Heart failure

3 endpoints
Secondary/protocol endpoint

Worsening heart failure event (exacerbated symptoms of heart failure resulting in hospitalization or intravenous diuretic therapy in an urgent care setting).

Time frame:Through study completion (1 day after cohort entry date until the first of outcome or censoring)

Heart-failure composite

time to event, event

componentsHeart-failure hospitalization, Urgent heart-failure visit

SNOMED 84114007

Secondary/protocol endpoint

Intravenous diuretic therapy in an urgent care setting

Time frame:Through study completion (1 day after cohort entry date until the first of outcome or censoring)

Urgent heart-failure visit

time to event, event

Secondary/protocol endpoint

Hospitalization for heart failure

Time frame:Through study completion (1 day after cohort entry date until the first of outcome or censoring)

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Urinary tract infection

Time frame:Through study completion (1 day after cohort entry date until the first of outcome or censoring)

time to event, event

Secondary/protocol endpoint

Serious bacterial infection

Time frame:Through study completion (1 day after cohort entry date until the first of outcome or censoring)

time to event, event

Secondary/protocol endpoint

Gastrointestinal adverse events

Time frame:Through study completion (1 day after cohort entry date until the first of outcome or censoring)

descriptive, event

Other clinical outcomes

2 endpoints
Other/protocol endpoint/low confidence

Hernia

Time frame:Through study completion (1 day after cohort entry date until the first of outcome or censoring)

time to event, event

Other/protocol endpoint

Lumbar radiculopathy

Time frame:Through study completion (1 day after cohort entry date until the first of outcome or censoring)

time to event, event

Publications (1)

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.