40 and older, any sex, with Obesity or Heart Failure With Preserved Ejection Fraction (HFpEF). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)Primary· Baseline, Week 52
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
Group
Value
95% CI
Tirzepatide - MTD
19.51
± 1.24
Placebo
12.68
± 1.25
First Occurrence of the Composite Endpoint of Heart Failure (HF) OutcomesPrimary· Baseline Up To 160 weeks
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 o
Group
Value
95% CI
Tirzepatide - MTD
36
Placebo
56
Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD)Secondary· Baseline, Week 52
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.
Group
Value
95% CI
Tirzepatide - MTD
26.04
± 3.81
Placebo
10.10
± 3.94
Percent Change From Baseline in Body WeightSecondary· Baseline, Week 52
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.
Group
Value
95% CI
Tirzepatide - MTD
-13.85
± 0.43
Placebo
-2.24
± 0.46
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)Secondary· Baseline, Week 52
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.
Group
Value
95% CI
Tirzepatide - MTD
-38.76
± 4.47
Placebo
-5.88
± 5.25
Win Percentage of the Hierarchical Composite EndpointSecondary· Baseline Up To 160 Weeks
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
Group
Value
95% CI
Tirzepatide - MTD
57.90
Placebo
35.43
Percentage of Participants With New York Heart Association (NYHA) Class ChangeSecondary· Week 52
Percentage of participants with NYHA class change at Week 52 was reported.
Group
Value
95% CI
Tirzepatide - MTD
33.27
Placebo
20.39
Number of Participants With Time to All-Cause DeathSecondary· Baseline Up To 160 Weeks
All-cause mortality is death due to any cause. Number of participants with time to all-cause mortality are presented.
Group
Value
95% CI
Tirzepatide - MTD
19
Placebo
15
Number of Participants With Time to First Occurrence of HF EventsSecondary· Baseline Up To 160 Weeks
Number of participants with time to first occurrence of HF events are reported.
Group
Value
95% CI
Tirzepatide - MTD
29
Placebo
52
Number of HF Events and All-Cause DeathSecondary· Baseline Up To 160 Weeks.
Number of HF events and all-cause death are reported.
Group
Value
95% CI
Tirzepatide - MTD
61
Placebo
82
Number of Recurrent HF EventsSecondary· Baseline Up To 160 Weeks.
Number of recurrent HF events were reported.
Group
Value
95% CI
Tirzepatide - MTD
44
Placebo
68
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline Up To 162 Weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07468552 — Trial of Tirzepatide for the Treatment of Cannabis Use Disorder
· Phase 2
· not yet recruiting
NCT06732245 — Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese
· Phase 2
· not yet recruiting
NCT07349641 — A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia
· Phase 2
· not yet recruiting
NCT07265752 — Tirzepatide for the Treatment of Cannabis Use Disorder
· Phase 2
· not yet recruiting
NCT07382024 — Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation
· NA
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 20 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04847557.