NCT05371496

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

Evaluation of the Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction (CAMEO-SEMA) A Phase II, Prospective, Double-Blind Randomized Trial

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Cardiomyopathy
• Heart Failure With Preserved Ejection Fraction (HFpEF)
• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-06
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2022-05-12
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study