NCT04847557

A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 731 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.

Detailed description

The study will continue until approximately 52 weeks after the last participant is randomized. The maximum duration of an individual's participation is estimated to be \~120 weeks and will depend on duration of study enrollment.

Conditions

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

Interventions

Type	Name	Description
DRUG	Tirzepatide	Administered SC
OTHER	Placebo	Administered SC

Timeline

• Start date: 2021-04-20
• Primary completion: 2024-07-02
• Completion: 2024-07-02
• First posted: 2021-04-19
• Last updated: 2025-08-20
• Results posted: 2025-08-20

Locations

146 sites across 10 countries: United States, Argentina, Brazil, China, India, Israel, Mexico, Puerto Rico, Russia, Taiwan

Regulatory

• FDA-regulated drug study