DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07554638

Not yet recruitingPhase 4

Incretin Therapies in Obesity-related HFpEF

Identifying Therapeutic Mechanisms for Incretin-Based Treatment in Obesity-Related Heart Failure With Preserved Ejection Fraction (HFpEF)

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

0

Recruiting sites

—

Enrollment

50

estimated

Study population

Heart failure, Obesity / overweight

Key I/E criteria

•BMI ≥30•EF ≥45%

Primary endpoint

•Plasma volume

Identifiers

Registered as

NCT IDNCT07554638
Org study IDAAAV9609

Timeline

Milestones

Study first posted2026-04-28actual
Last update posted2026-05-04actual
Study start2026-06estimated (month precision)
Primary completion2029-04estimated (month precision)
Study completion2030-04estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Heart failureObesity / overweight

Eligibility

Who can enroll

Minimum age40 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of heart failure (HF) per the ACC/AHA guidelines with NYHA class II-III symptoms
•Left ventricular ejection fraction >= 45% within 6 months of recruitment
•At least one of the following: elevated N-terminal pro- B-type natriuretic peptide (NT-proBNP) >=200 pg/ml (>=600 pg/ml with concurrent atrial fibrillation), evidence of structural heart disease (left atrial (LA) enlargement with LA volume index >29 mL/m2 or LA diameter >=40 mm in males/>38= mm in females), elevated filling pressures (resting wedge >15 mmHg or exercise wedge >25 mmHg, lateral E/e' ratio >12 or septal E/e' > 15)
•Body mass index (BMI) >30 kg/m2
•Stable doses of HF medications within 4 weeks of screening with optimal volume control in the opinion of the investigator.

Exclusion criteria

•Acute decompensated HF within 4 weeks of screening
•Major cardiovascular event within 90 days of screening (myocardial infarction, stroke)
•Alternate cause of HFpEF such as cardiac amyloidosis, infiltrative cardiomyopathy, hypertrophic cardiomyopathy, severe valvular disease
•Estimated glomerular fibrilation rate (EGFR) <15 ml/min/1.73m2 or dialysis dependence
•Poorly controlled diabetes (A1c > 9.5%) OR any type 1 diabetes mellitis
•History of acute or chronic pancreatitis
•Personal or family history of multiple endocrine neoplasia (MEN) or medullary thyroid cancer
•Clinically significant gastric emptying abnormality
•Medical comorbidities that limit survival
•Inability to comply with the study protocol
•Pregnancy

Endpoints (8)

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

Weight & body composition
3
Cardiometabolic biomarkers
2
Other (unclassified)
2
Heart failure
1

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Fat mass

Time frame:12 months

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Lean mass

Time frame:12 months

Lean mass

change from baseline, improvement

Other/protocol endpoint

Change in total body water

Time frame:12 months

change from baseline, improvement

Heart failure

1 endpoint
Other/protocol endpoint

Change in KCCQ clinical summary score

Time frame:12 months

KCCQ clinical summary

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Other/protocol endpoint

Change in serum leptin

Time frame:12 months

Leptin, change

change from baseline, improvement

Other/protocol endpoint

Change in serum adiponectin

Time frame:12 months

Adiponectin, change

change from baseline, improvement

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Plasma volume

Time frame:12 months

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in left atrial volume

Time frame:12 months

change from baseline, improvement

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.