A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
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ClinicalTrials.gov Identifier: NCT04847557 |
Recruitment Status :
Active, not recruiting
First Posted : April 19, 2021
Last Update Posted : April 22, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Heart Failure With Preserved Ejection Fraction (HFpEF) | Drug: Tirzepatide Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 731 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | April 20, 2021 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | July 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Tirzepatide
Tirzepatide administered subcutaneously (SC)
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Drug: Tirzepatide
Administered SC
Other Name: LY3298176 |
Placebo Comparator: Placebo
Placebo administered SC
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Other: Placebo
Administered SC |
- Change from Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) [ Time Frame: Baseline, Week 52 ]
- Occurrence of the Composite Endpoint of Cardiovascular (CV) Death and/or Heart Failure (HF) Events Over Time [ Time Frame: Baseline to Study Completion (estimated up to 120 weeks) ]
- Change from Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD) [ Time Frame: Baseline, Week 52 ]
- Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 52 ]
- Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Baseline, Week 52 ]
- A hierarchical Composite of All-Cause Mortality, HF events, KCCQ-CSS, and 6MWD Category [ Time Frame: Baseline to Study Completion (estimated up to 120 weeks) ]Hierarchical Composite of Time to All-Cause Mortality, Number of Heart Failure Events, Time to First HF Events, KCCQ-CSS, and 6MWD will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the components.
- Percentage of Participants with New York Heart Association (NYHA) Class Change [ Time Frame: Week 52 ]
- Time to All-Cause Death [ Time Frame: Baseline to Study Completion (estimated up to 120 weeks) ]
- Time to First Occurrence of HF Events [ Time Frame: Baseline to Study Completion (estimated up to 120 weeks) ]
- Time to Recurrent HF Events and All-Cause Death [ Time Frame: Baseline to Study Completion (estimated up to 120 weeks) ]
- Time to Recurrent HF Events [ Time Frame: Baseline to Study Completion (estimated up to 120 weeks) ]
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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Estimated glomerular filtration rate (eGFR) <70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening,
- Stable dose of heart failure medications within 4 weeks of screening
- Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²)
- 6MWD 100-425m
- KCCQ CSS ≤80
Exclusion Criteria:
- Have had a major cardiovascular event within the last 90 days of screening
- Have had acute decompensated heart failure within 4 weeks of screening
- Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions
- Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular heart disease
- HbA1c ≥9.5% or uncontrolled diabetes
- History of proliferative diabetic retinopathy or diabetic maculopathy
- Have a history of pancreatitis
- eGFR <15 mL/min/1.73 m² or requiring dialysis at screening
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847557
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04847557 |
Other Study ID Numbers: |
17757 I8F-MC-GPID ( Other Identifier: Eli Lilly and Company ) |
First Posted: | April 19, 2021 Key Record Dates |
Last Update Posted: | April 22, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data are available 6 months after the primary publication and approval of the indication studied in the US and European (EU), whichever is later. Data will be indefinitely available for requesting. |
Access Criteria: | A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
URL: | http://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Heart Failure with Preserved Ejection Fraction (HFpEF) |
Heart Failure Obesity Overweight Overnutrition Nutrition Disorders Body Weight Heart Diseases |
Cardiovascular Diseases Tirzepatide Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |