Incretin Therapies in Obesity-related HFpEF

NCTNCT07554638Other idAAAV9609

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Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 50 participants (estimated)
Sponsor: Columbia University · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 7 Aug 2026
Primary completion: Apr 2029 (estimated)
Completion: Apr 2030 (estimated)
First posted: 28 Apr 2026
Last update posted: 24 Aug 2026
Conditions: Heart Failure, Diastolic · Heart Failure With Preserved Ejection Fraction · Obesity

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202620272028202920302031

Ph 4
Incretin Therapies in Obesity-related HFpEF
NCT07554638
7 Aug 2026 to est. Apr 2030

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The central hypothesis to be tested is that patients with obesity and heart failure with preserved ejection fraction (HFpEF) prescribed tirzepatide will demonstrate reductions in measured plasma volume. In conjunction with state-of-the-art body composition analysis and measures of adipokines, this will establish an important mechanism of clinical benefit and inform disease pathophysiology. To accomplish this, this study will perform a 15-month prospective cohort study in 50 patients with obesity and HFpEF who clinically qualify for treatment with tirzepatide. The investigators will serially measure plasma volume and body composition with quantitative magnetic resonance to determine changes over time with tirzepatide treatment.

Interventions

TirzepatideDrug

Arms1

Experimental
Tirzepatide
After a 3-month control period, participants will be prescribed tirzepatide and undergo serial plasma volume measurement and body composition analysis. Participants will be prescribed tirzepatide under the brand name Monjauro if they have diabetes, and under the brand name Zepbound if they do not have diabetes. All participants will be initiated on an initial dose of 2.5 mg injected subcutaneously in the thigh or abdomen every week on same day and at the same time.

Primary outcomes1

Outcomes the sponsor listed as primary.

Plasma volume
Time frame · 12 months
Registry description
Plasma volume is measured using 131-iodine labeled serum albumin. The isotope is injected via an intravenous line and serial blood samples are taken and analyzed using the Blood Volume Analyzer-100 to derive the participant's blood volume and plasma volume. This will be performed at serial visits to determine the effect of tirzepatide therapy on measured plasma volume over time.

Secondary outcomes(2)

Fat mass
Time frame · 12 months
Registry description
Body composition analysis will be performed with quantitative magnetic resonance (QMR). QMR will be performed early morning in a fasting state with participants in uniform hospital gowns and socks. Briefly, the QMR system generates a signal that modifies the spin of hydrogen atoms and uses an algorithm to evaluate the resulting T1 and T2 relaxation curves specific to one of the components of body composition: fat mass, fat-free mass, total body water. This will be performed at serial visits to determine the effect of tirzepatide therapy on fat mass over time.
Lean mass
Time frame · 12 months
Registry description
Body composition analysis will be performed with QMR. QMR will be performed early morning in a fasting state with participants in uniform hospital gowns and socks. Briefly, the QMR system generates a signal that modifies the spin of hydrogen atoms and uses an algorithm to evaluate the resulting T1 and T2 relaxation curves specific to one of the components of body composition: fat mass, fat-free mass, total body water. This will be performed at serial visits to determine the effect of tirzepatide therapy on lean mass over time.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

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Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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