Tirzepatide for Heart Failure and Obesity (SUMMIT Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing a medication called Tirzepatide to see if it can help people who have a certain type of heart failure and are also obese. The medication aims to control blood sugar and reduce weight, which may improve their heart condition. Tirzepatide is developed by Eli Lilly and is under investigation for chronic weight management and other conditions.

Eligibility Criteria

This trial is for adults with heart failure where the heart pumps well (preserved ejection fraction) and who are obese. They must be on stable heart medications, have certain levels of NT-proBNP depending on atrial fibrillation status, experience specific structural heart changes or pressure issues, and have a limited ability to walk distances. Excluded are those with recent major cardiovascular events, acute decompensated heart failure, severe diabetes or kidney disease, other serious health conditions affecting function.

Inclusion Criteria

My heart failure is stable, and my heart pumps well.

My heart test results show high NT-proBNP levels or I have a heart condition.

My kidney function is reduced, or I've had heart failure worsening in the last year.

I can walk between 100 to 425 meters without stopping.

My heart failure is stable, and my heart pumps well.

My heart tests show high NT-proBNP levels or I have a heart condition.

My kidney function is reduced or I've had heart failure worsening in the last year.

I can walk between 100 to 425 meters without stopping.

My heart failure is stable, and my heart pumps well.

My heart test results show high NT-proBNP levels or I have a heart condition.

My kidney function is reduced or I've had heart failure worsening in the last year.

I can walk between 100 to 425 meters without stopping.

Exclusion Criteria

I have had a major heart event in the last 3 months.

I had a sudden worsening of my heart failure within the last month.

I have a serious heart condition related to amyloidosis or valve disease.

My HbA1c level is 9.5% or higher, or my diabetes is not under control.

I have had severe diabetic eye disease.

I have had pancreatitis before.

My kidney function is very low or I am on dialysis.

Treatment Details

The study tests Tirzepatide's effectiveness and safety in people with obesity-related preserved ejection fraction heart failure against a placebo. Participants will either receive Tirzepatide or an inactive substance without knowing which one they're getting to compare outcomes fairly.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TirzepatideExperimental Treatment1 Intervention

Tirzepatide administered subcutaneously (SC)

Group II: PlaceboPlacebo Group1 Intervention

Placebo administered SC

Tirzepatide is already approved in United States, European Union, Canada, Australia, United States, United Kingdom for the following indications:

🇺🇸 Approved in United States as Mounjaro for: