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

NCT05371496 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-03-06

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Semaglutide

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

DRUG

Placebo

Matched placebo with no active drug once weekly for 12 months

BEHAVIORAL

Counselling on healthy lifestyle intervention

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Barry Borlaug, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05371496 on ClinicalTrials.gov