Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction

NCT05371496 · Enrolling by invitation

Last updated 2026-05-28

This clinical trial tested the effects of semaglutide, a medication, on heart and metabolic health in adults with heart failure with preserved ejection fraction (HFpEF) and obesity.

Status Enrolling by invitation Only people invited by the researchers can join.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 81 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2022-09 · est. completion 2026-08

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT05371496 ↗

Description as written by the study sponsor.

The purpose of this research is to find out if an aggressive intervention to lose weight, will improve symptoms in patients with obesity-related cardiomyopathy, which is also known as the obese phenotype of heart failure with preserved ejection fraction (HFpEF).

Treatments tested

Semaglutide Drug

3.0 mg/ml (titrated to 2.4 mg) subcutaneous once weekly for 12 months
Placebo Drug

Matched placebo with no active drug once weekly for 12 months
Counselling on healthy lifestyle intervention Behavioral

All participants will receive counselling on healthy lifestyle intervention including limiting consumption of salt, red meat, saturated or trans fats, sweets, and sugar-sweetened beverages, and how to restrict calorie intake (500 kcal/day deficit) in consultation with a trained study dietician. Regular physical activity \>150 minutes per week will be encouraged.

Main thing measured	Pulmonary Capillary Wedge Pressure (PCWP)
Sponsor	Mayo Clinic
Conditions studied	Cardiomyopathy, Heart Failure With Preserved Ejection Fraction (HFpEF), Obesity
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05371496 ↗