What is the mechanism of action of this treatment?

Common treatments for Heart Failure (HF) include medications that reduce the workload on the heart and improve its efficiency. GLP-1 receptor agonists, such as those similar to Tirzepatide, enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which helps in managing blood glucose levels. These agents also have cardiovascular benefits, which are crucial for HF patients as they can improve heart function and reduce symptoms. Tirzepatide, a dual GIP and GLP-1 receptor agonist, may offer enhanced metabolic and cardiovascular benefits, potentially leading to better outcomes for HF patients.

What side effects are associated with this type of intervention?

Common side effects of GLP-1 receptor agonists, which are similar to Tirzepatide, include gastrointestinal issues such as nausea, vomiting, and diarrhea. There are also concerns about the risk of pancreatitis and potential pancreatic cancer. Other side effects may include injection site reactions and gallbladder-related issues like cholelithiasis. While cardiovascular effects are generally positive, individual responses can vary.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for various conditions, including type 2 diabetes and obesity, which are relevant to heart failure management due to their effects on weight and metabolic control. Notably, Liraglutide and extended-release Exenatide have been approved for use in children and adolescents with type 2 diabetes, and Dulaglutide has shown efficacy in improving glycemic control. These drugs, while primarily targeting diabetes, have implications for heart failure management due to their cardiovascular benefits. However, specific FDA approvals for GLP-1 receptor agonists directly targeting heart failure are limited, and ongoing studies like the SUMMIT trial for Tirzepatide aim to explore this potential further.

What other types of research exist?

Promising alternatives to Tirzepatide for heart failure patients in 2024 include Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors like dapagliflozin and empagliflozin, which have shown benefits in heart failure patients. Additionally, novel agents such as vericiguat, a soluble guanylate cyclase stimulator, and omecamtiv mecarbil, a cardiac myosin activator, are emerging treatments that may offer new therapeutic options.

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Glucagon-like peptide-1 (GLP-1) receptor agonist

Tirzepatide for Heart Failure and Obesity (SUMMIT Trial)

Phase 3

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%

Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) > 200 pg/ml for participants without atrial fibrillation (AF), or >600 picogram/milliliter (pg/ml) for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure

Must not have

Have had a major cardiovascular event within the last 90 days of screening

Have had acute decompensated heart failure within 4 weeks of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to study completion (estimated up to 120 weeks)

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects of drugs like Tirzepatide may include gastrointestinal symptoms such as nausea and diarrhea, potential low blood sugar levels especially in diabetics, injection site reactions if it's injectable medication, and possibly increased risk of pancreatitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

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

Select...

I can walk between 100 to 425 meters without stopping.

Select...

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

Select...

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

Select...

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

Select...

I can walk between 100 to 425 meters without stopping.

Select...

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

Select...

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

Select...

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

Select...

I can walk between 100 to 425 meters without stopping.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

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

Select...

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

Select...

I have had severe diabetic eye disease.

Select...

I have had pancreatitis before.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to study completion (estimated up to 120 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to study completion (estimated up to 120 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to study completion (estimated up to 120 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

A hierarchical Composite of All-Cause Mortality, HF events, KCCQ-CSS, and 6MWD Category

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032

40%

Diarrhoea

30%

Nausea

27%

Decreased appetite

23%

Upper respiratory tract infection

19%

Abdominal distension

11%

Vomiting

11%

Gastroenteritis

Flatulence

Abortion induced

Abdominal pain upper

Gingivitis

Amylase increased

Lipase increased

Abdominal pain

Injection site reaction

Menstruation irregular

Hepatic function abnormal

Hyperuricaemia

Uterine polyp

Vaginal infection

Dizziness

Hand fracture

Supraventricular tachycardia

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Tirzepatide

15 mg Tirzepatide

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TirzepatideExperimental Treatment1 Intervention

Tirzepatide administered subcutaneously (SC)

Group II: PlaceboPlacebo Group1 Intervention

Placebo administered SC

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

2019

Completed Phase 3

~7520

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Heart Failure (HF) include medications that reduce the workload on the heart and improve its efficiency. GLP-1 receptor agonists, such as those similar to Tirzepatide, enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which helps in managing blood glucose levels. These agents also have cardiovascular benefits, which are crucial for HF patients as they can improve heart function and reduce symptoms. Tirzepatide, a dual GIP and GLP-1 receptor agonist, may offer enhanced metabolic and cardiovascular benefits, potentially leading to better outcomes for HF patients.