Incretin Therapies in Obesity-related HFpEF

What Was Tested

In this phase 4 trial, researchers set out to test Tirzepatide.

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.

It had 1 arm (groups): Tirzepatide (experimental).

The registry classes the interventions as drug.

More on the Plan

Accordingly, anti-obesity medications are a major focus of recent clinical investigation in patients with obesity and HFpEF.

A major mechanism responsible for PV expansion in obesity is elevated serum leptin, an adipokine with a concentration directly proportional to fat mass.

In excess, leptin activates neurohormonal and sympathetic pathways that result in hyperaldosteronism, perpetuating sodium retention and PV expansion in HFpEF.

Compared to those without obesity, patients with obesity and HFpEF have greater left atrial (LA) dilatation, greater concentric left ventricular (LV) remodeling, greater right ventricular (RV) dysfunction, and elevated resting and exercise intracardiac filling pressures.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to people of any sex aged from 40 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of heart failure (HF) per the ACC/AHA guidelines with NYHA class II-III symptoms. Body mass index (BMI) \>30 kg/m2.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Tirzepatide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-08-07 with completion listed for 2029-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Plasma volume (time frame: 12 months).

It also tracked 2 secondary outcomes, for example Fat mass and Lean mass.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Tirzepatide in 50 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.