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

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT04847557
Phase
PHASE3
Status
Completed

Conditions

  • Heart Failure With Preserved Ejection Fraction (HFpEF)
  • Obesity

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Placebo — OTHER
    Administered SC

Study Details

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.

Key Dates

Start date
Apr 20, 2021
Status verified
Aug 2025
Primary completion
Jul 2, 2024
Completion
Jul 2, 2024

Study Design

Enrollment
731 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) and escalated by 2.5 mg every 4 weeks to a maximum of 15 mg QW or maximum tolerated dose (MTD) tolerated by the participant (5 mg QW or 10 mg QW).
  • Placebo Comparator: Placebo
    Participants received placebo administered SC QW.

Primary Outcome Measure

Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) [ Time Frame: Baseline, Week 52 ]

Locations (54)

FacilityCityStateZIPSite coordinators
Heart Center ResearchHuntsvilleAlabama35801-
Westside Medical Associates of Los AngelesBeverly HillsCalifornia90211-
Valley Clinical Trials, Inc.CovinaCalifornia91723-
Amicis Research CenterGranada HillsCalifornia91344-
University of California San Diego - La JollaLa JollaCalifornia92037-
Valley Clinical Trials, Inc.NorthridgeCalifornia91325-
The Lundquist InstituteTorranceCalifornia90502-
South Denver Cardiology AssociatesLittletonColorado80120-
Cardiology Associates of Fairfield County, P.C.StamfordConnecticut06905-
Excel Medical Clinical TrialsBoca RatonFlorida33434-
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.ClearwaterFlorida33756-
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.LargoFlorida33777-
Infinite Clinical ResearchMiamiFlorida33133-
Ocala Caridovascular ResearchOcalaFlorida34471-
Clearwater Cardiovascular & Interventional Consultants M.D., P.A.Safety HarborFlorida34695-
East Coast Institute for Research - St. AugustineSaint AugustineFlorida32086-
Morehouse School Of MedicineAtlantaGeorgia30310-
St. Luke's Boise Medical CenterBoiseIdaho83712-
Northwest Heart Clinical ResearchArlington HeightsIllinois60005-
Methodist Medical Center of IllinoisPeoriaIllinois61636-
Cardiovascular Research of Northwest IndianaMunsterIndiana46321-
Midwest Heart & Vascular SpecialistsOverland ParkKansas66211-
Grace Research - BossierBossier CityLouisiana71111-
The Heart Clinic - HammondHammondLouisiana70403-
Grace Research - ShreveportShreveportLouisiana71105-
Maryland Cardiovascular SpecialistsBaltimoreMaryland21229-
McLaren Bay RegionBay CityMichigan48708-
St. Louis Heart and Vascular, P.C.St LouisMissouri63136-
Palm Research Center TenayaLas VegasNevada89128-
The Heart HouseHaddon HeightsNew Jersey08035-
Lovelace Medical CenterAlbuquerqueNew Mexico87102-
Erie County Medical CenterBuffaloNew York14215-
Rochester General HospitalRochesterNew York14621-
Saratoga Cardiology AssociatesSaratoga SpringsNew York12866-
Stony Brook UniversityStony BrookNew York11794-
OnSite Clinical SolutionsCharlotteNorth Carolina28277-
Aultman Hospital ResearchCantonOhio44710-
Rama ResearchMarionOhio43302-
Hightower Clinical Trial ServicesOklahoma CityOklahoma73102-
Hillsboro CardiologyHillsboroOregon97123-
Capital Area Research, LLCCamp HillPennsylvania17011-
Doylestown HospitalDoylestownPennsylvania18901-
UPMC Clinical TrialsPittsburghPennsylvania15213-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Monument Health Rapid City HospitalRapid CitySouth Dakota57701-
The Stern Cardiovascular FoundationGermantownTennessee38138-
Apex Research FoundationJacksonTennessee38301-
DiscoveResearchBeaumontTexas77701-
UT Southwestern Medical CenterDallasTexas75390-
North Dallas Research AssociatesMcKinneyTexas75069-
Sherman Clinical ResearchShermanTexas75092-
Northwest Houston Heart CenterTomballTexas77375-
Intermountain Medical CenterMurrayUtah84107-
MultiCare Good Samaritan HospitalPuyallupWashington98372-

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