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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
731
Administered SC
Administered SC
Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
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 .
Time frame: Baseline, Week 52
First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes
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.
Time frame: Baseline Up To 160 weeks
Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD)
Participants performed an exercise capacity assessment using the 6-Minute Walk Test (6MWT) and the distance covered (6MWD) was assessed in meters. The 6MWT was performed indoors on a straight, flat, hard surface that is at least 30 meters in length. The greater distance walked meant better physical capacity. 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.
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Heart Center Research
Huntsville, Alabama, United States
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States
Valley Clinical Trials, Inc.
Covina, California, United States
Amicis Research Center
Granada Hills, California, United States
University of California San Diego - La Jolla
La Jolla, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
The Lundquist Institute
Torrance, California, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
Cardiology Associates of Fairfield County, P.C.
Stamford, Connecticut, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
...and 136 more locations
Time frame: Baseline, Week 52
Percent Change From Baseline in Body Weight
Percent change in bodyweight was reported. 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.
Time frame: Baseline, Week 52
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Percent change from baseline in hsCRP was reported. LS Mean was determined using ANCOVA model with log (actual measurement/baseline) = log (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.
Time frame: Baseline, Week 52
Win Percentage of the Hierarchical Composite Endpoint
Hierarchical Composite Endpoint included time to all-cause death, number of HF events, time to first HF events, KCCQ-CSS, 6MWD. The winner was determined in each pair-wise comparison in the following order: * A delayed first occurrence of all-cause death * If the pair cannot be differentiated based on death, winner has fewer HF events * If the pair cannot be differentiated by number of HF events, winner has delayed time to occurrence of first HF event * If the pair still cannot be differentiated, winner has a more favorable category for change from baseline in 6MWD * If the pair still cannot be differentiated, winner has a more favorable category for change from baseline in KCCQ-CSS * Otherwise the pair will be recorded as tied. Reported unit is the total percent of "wins" for each treatment group from performing such a hierarchical comparison across stratification factors in the study.
Time frame: Baseline Up To 160 Weeks
Percentage of Participants With New York Heart Association (NYHA) Class Change
Percentage of participants with NYHA class change at Week 52 was reported.
Time frame: Week 52
Number of Participants With Time to All-Cause Death
All-cause mortality is death due to any cause. Number of participants with time to all-cause mortality are presented.
Time frame: Baseline Up To 160 Weeks
Number of Participants With Time to First Occurrence of HF Events
Number of participants with time to first occurrence of HF events are reported.
Time frame: Baseline Up To 160 Weeks
Number of HF Events and All-Cause Death
Number of HF events and all-cause death are reported.
Time frame: Baseline Up To 160 Weeks.
Number of Recurrent HF Events
Number of recurrent HF events were reported.
Time frame: Baseline Up To 160 Weeks.