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

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ClinicalTrials.gov Identifier: NCT04847557
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Heart Failure With Preserved Ejection Fraction Drug: Tirzepatide Other: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 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 30, 2024
Estimated Study Completion Date : July 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Tirzepatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tirzepatide
Tirzepatide administered subcutaneously (SC)
 Drug: Tirzepatide
Administered SC
Other Name: LY3298176
Placebo Comparator: Placebo
Placebo administered SC
 Other: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Randomization (Week 0) 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, 6MWD, and KCCQ CSS 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.

  2. Change from Baseline in Exercise Capacity as Measured by 6MWD [ Time Frame: Baseline, Week 52 ]

Secondary Outcome Measures :
  1. Percent Change from Baseline in Body Weight Loss [ Time Frame: Baseline, Week 52 ]
  2. Change from Baseline in the KCCQ CSS [ Time Frame: Baseline, Week 52 ]
  3. Change from Baseline in 6MWD [ Time Frame: Baseline, Week 24 ]
  4. Percentage of Participants with New York Heart Association (NYHA) Class Change [ Time Frame: Week 52 ]
  5. Time to First Occurrence of HF Events or Cardiovascular (CV) Death [ Time Frame: Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks) ]
  6. Time to First Occurrence of HF Events or All-Cause Death [ Time Frame: Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks) ]
  7. Time to First Occurrence of HF Events [ Time Frame: Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks) ]
  8. Time to Recurrent Events of HF Events and CV Death [ Time Frame: Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks) ]
  9. Time to Recurrent Events of HF Events [ Time Frame: Randomization (Week 0) to Study Completion (Estimated Up to 120 Weeks) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 hear 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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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: May 24, 2023
Last Verified: May 2023
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Heart Failure with Preserved Ejection Fraction (HFpEF)
Additional relevant MeSH terms:
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Heart Failure
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Heart Diseases
 Cardiovascular Diseases
Tirzepatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists