← Trials/Trial dossier/NCT06914154

DUP-SUMMIT

Completed

Emulation of the SUMMIT Heart Failure Trial in Healthcare Claims Data

Lead sponsor

Brigham and Women's Hospital

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

11,265

actual

Study population

Heart failure, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•eGFR ≤70•EF ≥50%

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 IDNCT06914154

Org study ID2018P002966-DUP-SUMMIT

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

Tirzepatide

Study populations

Who this study enrolls

Heart failureObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age40 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

The study population included 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

FOLLOWING ELIGIBILITY OF THE SUMMIT TRIAL

Inclusion Criteria:

•≥ 40 years old, male or female sex

•Chronic heart failure (NYHA Class II-IV) diagnosed for at least 3 months before Visit 1

•LVEF ≥50% demonstrated by echocardiogram performed at Visit 1 or within 6 months of Visit 1

•Structural heart disease

•Either one of: (1) eGFR <70 mL/min/1.73m2 at Visit 1, (2) HF decompensation within 12 months of Visit 1, defined as hospitalization for HF requiring IV diuretic treatment or urgent HF visit requiring IV diuretic treatment

•Stable dose of all concomitant HF medications (that is, beta blockers, ACEis, ARBs, and MRAs), except for oral diuretics, for at least 4 weeks prior to Visit 1 a

•If treated with oral diuretics, dose must be stable for at least 2 weeks prior to Visit 1 and throughout the screening period; volume control must be optimally achieved in the opinion of the investigator

•BMI ≥27.0 kg/m2 at Visit 1

•Type 2 diabetes mellitus trial subgroup

Exclusion criteria

•Myocardial infarction, coronary artery bypass graft surgery, or other major CV surgery/intervention, stroke or transient ischemic attack in past 90 days, or unstable angina pectoris in past 30 days, prior to Visit 1 or during screening

•Lung disease: pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension (CTEPH), or severe pulmonary disease including (COPD)

•Other medical conditions: severe anemia (hemoglobin level <9 g/dL) at Visit 1, untreated thyroid disease or TSH >4.0 mU/L at Visit 1, or significant musculoskeletal disease

•Orthopedic conditions that limit the ability to walk, such as severe arthritis in the leg, knee, hip injuries, hemiplegia, or amputation with artificial limb without stable prosthesis function

•Any condition that in the opinion of the investigator would interfere with the assessment of 6MWT

•LVEF <40% by local echocardiography documented any time within 2 years of Visit 1

•Acute decompensated HF (exacerbation of HF) requiring IV diuretics, IV inotropes, or IV vasodilators, or left ventricular assist device (LVAD) within 4 weeks prior to Visit 1, and/or during the screening period until randomization

•Impaired renal function, defined as eGFR <15 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis at Visit 1

•Any one of the following: (1) Systolic blood pressure (SBP) ≥180 mmHg at Visit 1 (2) SBP >160 mmHg both at Visit 1 and at Visit 2 (3) Have symptomatic hypotension or SBP <100 mmHg at Visit 1 or Visit 2

•Atrial fibrillation or atrial flutter with a resting heart rate >110 bpm documented by ECG at Visit 1

•Cardiac amyloidosis or cardiomyopathy based on accumulation disease (for example, haemochromatosis, Fabry disease), muscular dystrophy, cardiomyopathy with reversible causes (for example, stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction, or any severe (obstructive or regurgitant) valvular heart disease likely to lead to surgery during the study period

•Completed prior surgical treatment for obesity or had liposuction or abdominoplasty within 1 year prior to Visit 1. Participants who plan to have surgical treatment for obesity or liposuction or abdominoplasty during the duration of the study are excluded.

•Have type 1 diabetes mellitus

•For type 2 diabetes mellitus (1) Have uncontrolled diabetes requiring immediate therapy (such as diabetic ketoacidosis) at Visit 1 or Visit 2, in the judgement of the physician (2) Have had 1 or more events of severe hypoglycemia and/or 1 or more events of hypoglycemia unawareness within 6 months prior to Visit 1 (see Section 10.5.1.1 for definition of hypoglycemia) (3) Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment. Patients with T2DM should have had a dilated fundoscopic examination, performed by an ophthalmologist or optometrist, within 12 months of Visit 1 or prior to randomization (4) Treated with premix or prandial insulins or intensified insulin regimens (multiple daily injection with basal and prandial insulins or insulin pump therapy) at Visit 1

•History of acute or chronic pancreatitis or at high risk for acute pancreatitis (for example, serum triglyceride level >500 mg/dL

•Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or any of the following, as determined by the central laboratory during Visit 1: ALT or AST levels >2.5X the ULN for the reference range.

•Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2

•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

•Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol

•Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility

•Treatment with any incretin, GLP-1 RA, or pramlintide in the 3 months prior to Visit 1

•Implantable cardioverter defibrillator (ICD) implantation within 1 month prior to Visit 1 or planned implantation during the course of the study

•Currently implanted left ventricular assist device (LVAD)

•Cardiac resynchronization therapy (CRT) implanted within 6 months prior to Visit 1 or planned implantation during the course of the trial

•Current use of medication associated with weight gain or weight loss, except when on stable dose for at least 3 months prior to Visit 1, and expected to be stable during the study period

•Pregnancy

RELAXING ELIGIBILITY OF THE SUMMIT TRIAL

Inclusion Criteria:

•Men or women ≥ 40 years old

•History of type 2 diabetes mellitus

•BMI ≥ 27.0 kg/m2

•Heart failure

•Preserved ejection fraction

Exclusion Criteria:

•Prior treatment with any GLP-1-RA

•History of type 1 diabetes mellitus

•End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis

•History of bariatric surgery

•History of nursing home admission

•Pregnant female or breast-feeding

•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy

•Treatment with continuous subcutaneous insulin infusion

•Multiple endocrine neoplasia type 2 or medullary thyroid carcinoma

•Pregnancy

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

Heart failure

Cardiovascular outcomes

Safety / tolerability / PK

Other clinical outcomes

Cardiovascular outcomes

3 endpoints

Primary/protocol endpoint

Composite of all-cause mortality or heart failure hospitalisation.

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

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

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

4 endpoints

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 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)

Expanded / custom MACE composite

time to event, event

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

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 effects

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

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

Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction.
JAMA2025 Oct 14PMID40886075doi:10.1001/jama.2025.14092via clinicaltrials gov reference derived + pubmed nct search

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.