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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization (week 0) to study completion (estimated up to 120 weeks)
Awards & highlights

SUMMIT Trial Summary

This trial will study the effects of Tirzepatide in people with heart failure and obesity.

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.Check my eligibility
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.See study design
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.

SUMMIT Trial 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.

SUMMIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization (week 0) to study completion (estimated up to 120 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization (week 0) to study completion (estimated up to 120 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A Hierarchical Composite of All-Cause Mortality, Heart Failure Events, 6-minute Walk Test Distance (6MWD) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Category
Change from Baseline in Exercise Capacity as Measured by 6MWD
Secondary outcome measures
Change from Baseline in 6MWD
Change from Baseline in the KCCQ CSS
Percent Change from Baseline in Body Weight Loss
+6 more

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%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo

SUMMIT 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
~7590

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,229 Total Patients Enrolled
13 Trials studying Heart Failure
19,706 Patients Enrolled for Heart Failure
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,552 Total Patients Enrolled
2 Trials studying Heart Failure
482 Patients Enrolled for Heart Failure

Media Library

Tirzepatide (Glucagon-like peptide-1 (GLP-1) receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04847557 — Phase 3
Heart Failure Research Study Groups: Tirzepatide, Placebo
Heart Failure Clinical Trial 2023: Tirzepatide Highlights & Side Effects. Trial Name: NCT04847557 — Phase 3
Tirzepatide (Glucagon-like peptide-1 (GLP-1) receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04847557 — Phase 3
Heart Failure Patient Testimony for trial: Trial Name: NCT04847557 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other studies have been done that use Tirzepatide?

"Tirzepatide was first explored in 2019 by American Research Corporation at Texas Liver Institute. Since then, there have been 18302 completed studies with 10 more currently ongoing. The majority of these active trials are taking place in Torrance, California."

Answered by AI

Are new participants being accepted into this research project?

"Yes, you're correct. The latest information from clinicaltrials.gov shows that this experiment is still looking for participants. It was first posted on 4/20/2021 and updated 11/10/2022. Currently, there are 50 different locations where the trial is taking place and they are hoping to enroll 700 individuals in total."

Answered by AI

What possible adverse effects could patients experience from taking Tirzepatide?

"There is evidence from Phase 3 trials to support the efficacy and safety of Tirzepatide, which our team has rated a 3 on a scale of 1-3."

Answered by AI

To your knowledge, are there any other similar studies that have been undertaken?

"As of right now, there are 10 ongoing Tirzepatide trials in 31 countries and 621 cities. The first trial was completed in 2019 by196 participants. It went through Phase 2 approval and was sponsored by Eli Lilly and Company. In the two years since that original study, 18302 more trials have been conducted."

Answered by AI

Where can patients enroll in this trial?

"There are 50 sites conducting this study currently, with some in Torrance, Peoria and Canton. To reduce the burden of travel for participants, please select the site closest to your location."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Missouri
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
St. Luke's Boise Medical Center
St. Louis Heart and Vascular, P.C.
Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0

What questions have other patients asked about this trial?

Can I be on other medications during the study? How long does the screening take and what will be done?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I need to lose weight. I’m sick of being over weight. Hi I’m Linda Cook I’m 67 yrs old I saw your trial.
PatientReceived 1 prior treatment
I had weight loss surgery 07/2020 and I'm now gaining my weight back. Last month my doctor said she'd like to get me on this type of drug.
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Aultman Hospital Research: < 48 hours
  2. Clinical Trials Unit: < 48 hours
  3. Capital Area Research, LLC: < 48 hours
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity
2021. "A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04847557.
All > Heart Failure With Preserved Ejection Fraction
~37 spots leftby Jun 2024
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