Completed
PHASE3
INTERVENTIONAL
NCT04847557
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
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.
Interventions
Name:
Tirzepatide
Type:
DRUG
Description:
Administered SC
Name:
Placebo
Type:
OTHER
Description:
Administered SC
Primary Outcomes
Measure:
Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
TimeFrame:
Baseline, Week 52
Description:
The KCCQ is a 23-item, participant self-administered questionnaire that assesses impacts of heart failure "over the past 2 weeks" on the following 7 domains:
* Physical Limitation (6)
* Symptom Stability (1)
* Symptom Frequency (4)
* Symptom Burden (3)
* Self-Efficacy (2)
* Quality of Life (3)
* Social Limitation (4)
Each of the 23 individual items are answered on Likert scales of varying lengths (5, 6, or 7-point scales).
KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are obtained by averaging the associated individual items and transforming the score to a 0 to 100 range. Higher scores indicate better health status.
Least Square (LS) mean was determined using ANCOVA model with Baseline + HF Decompensation Within 12 Months of Screening + T2DM Status + Baseline BMI group (\<35, \>=35 kg/m2) + Treatment (Type III sum of squares) as variables .
Measure:
First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes
TimeFrame:
Baseline Up To 160 weeks
Description:
Clinical Endpoint Committe confirmed Occurrences of CV outcomes were reported here. HF outcomes consisted of cardiovascular death and HF events.
The HF events were defined as worsening clinical symptoms or signs related to HF, which are meaningful to the participant and require intensification of treatment characterized by 1 or more of the following:
* hospitalization for heart failure regardless of duration or treatment received
* use of intravenous drug, usually an intravenous diuretic, but may include intravenous vasodilators or positive inotropic drugs, or
* augmentation or increase in oral diuretic therapy.
Trial Information
NCT ID
NCT04847557
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Eli Lilly and Company
Last Updated
December 15, 2025