Trial · NCT04847557
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
NCT04847557, Phase 3, Completed, Eli Lilly and Company; results first posted 2025-08-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial. Trials, record NCT04847557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04847557
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
- NCT number
- NCT04847557
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 731 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Obesity, Heart Failure With Preserved Ejection Fraction (HFpEF)
- Interventions
- Tirzepatide, Placebo
- First posted
- 2021-04-19
- Last updated
- 2025-08-20
- Results first posted
- 2025-08-20
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) | 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 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 . |
| Primary | First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes | 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 oral diuretic therapy. |
| Secondary | Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD) | 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. |
| Secondary | Percent Change From Baseline in Body Weight | 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. |
| Secondary | Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | 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. |
| Secondary | Win Percentage of the Hierarchical Composite Endpoint | 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 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. |
| Secondary | Percentage of Participants With New York Heart Association (NYHA) Class Change | Week 52 | Percentage of participants with NYHA class change at Week 52 was reported. |
| Secondary | Number of Participants With Time to All-Cause Death | 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. |
| Secondary | Number of Participants With Time to First Occurrence of HF Events | Baseline Up To 160 Weeks | Number of participants with time to first occurrence of HF events are reported. |
| Secondary | Number of HF Events and All-Cause Death | Baseline Up To 160 Weeks. | Number of HF events and all-cause death are reported. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) | Baseline, Week 52 | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes | Baseline Up To 160 weeks | All participants who received at least one dose of study drug. | Number of events | NUMBER |
| SECONDARY | Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD) | Baseline, Week 52 | All participants who received at least one dose of study drug and had evaluable data for this outcome, | meters | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Body Weight | Baseline, Week 52 | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | Baseline, Week 52 | All participants who received at least one dose of study drug and had evaluable data for this outcome. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Win Percentage of the Hierarchical Composite Endpoint | Baseline Up To 160 Weeks | All participants who received at least one dose of study drug. | Win percentage | NUMBER |
| SECONDARY | Percentage of Participants With New York Heart Association (NYHA) Class Change | Week 52 | All participant who received at least one dose of study drug and had evaluable data for this outcome. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Time to All-Cause Death | Baseline Up To 160 Weeks | All participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Time to First Occurrence of HF Events | Baseline Up To 160 Weeks | All participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of HF Events and All-Cause Death | Baseline Up To 160 Weeks. | All participants who received at least one dose of study drug. | Events | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) | Tirzepatide - MTD | 19.51 | Standard Error 1.24 | Score on a scale | |
| Change From Baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) | Placebo | 12.68 | Standard Error 1.25 | Score on a scale | |
| First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes | Tirzepatide - MTD | 36 | Number of events | ||
| First Occurrence of the Composite Endpoint of Heart Failure (HF) Outcomes | Placebo | 56 | Number of events | ||
| Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD) | Tirzepatide - MTD | 26.04 | Standard Error 3.81 | meters | |
| Change From Baseline in Exercise Capacity as Measured by 6-Minute Walk Distance (6MWD) | Placebo | 10.10 | Standard Error 3.94 | meters | |
| Percent Change From Baseline in Body Weight | Tirzepatide - MTD | -13.85 | Standard Error 0.43 | Percent change | |
| Percent Change From Baseline in Body Weight | Placebo | -2.24 | Standard Error 0.46 | Percent change | |
| Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | Tirzepatide - MTD | -38.76 | Standard Error 4.47 | Percent change | |
| Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | Placebo | -5.88 | Standard Error 5.25 | Percent change |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tirzepatide - MTD | 364 | |
| Overall Study | STARTED | Placebo | 367 | |
| Overall Study | Received At Least One Dose of Study Drug | Tirzepatide - MTD | 364 | |
| Overall Study | Received At Least One Dose of Study Drug | Placebo | 367 | |
| Overall Study | COMPLETED | Tirzepatide - MTD | 332 | |
| Overall Study | COMPLETED | Placebo | 331 | |
| Overall Study | NOT COMPLETED | Tirzepatide - MTD | 32 | |
| Overall Study | NOT COMPLETED | Placebo | 36 |
Source ClinicalTrials.gov
Adverse events396
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cardiac failure | Cardiac disorders | Tirzepatide - MTD | 11 | 364 | 19 |
| other | Cardiac failure | Cardiac disorders | Placebo | 20 | 367 | 24 |
| other | Abdominal pain upper | Gastrointestinal disorders | Tirzepatide - MTD | 19 | 364 | 24 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 7 | 367 | 10 |
| other | Constipation | Gastrointestinal disorders | Tirzepatide - MTD | 54 | 364 | 78 |
| other | Constipation | Gastrointestinal disorders | Placebo | 22 | 367 | 27 |
| other | Diarrhoea | Gastrointestinal disorders | Tirzepatide - MTD | 65 | 364 | 185 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 23 | 367 | 33 |
| other | Dyspepsia | Gastrointestinal disorders | Tirzepatide - MTD | 23 | 364 | 30 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 8 | 367 | 11 |
1 to 10 of 396Source ClinicalTrials.gov
See all 396 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tirzepatide - MTD | 19 | 364 |
| Total, all-cause mortality | Placebo | 15 | 367 |
| Total, other adverse events | Tirzepatide - MTD | 221 | 364 |
| Total, other adverse events | Placebo | 137 | 367 |
| Total, serious adverse events | Tirzepatide - MTD | 96 | 364 |
| Total, serious adverse events | Placebo | 94 | 367 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tirzepatide - MTD vs Placebo: Number of Participants With Time to All-Cause Death | Trial comparisons |
| Tirzepatide - MTD vs Placebo: Number of Participants With Time to First Occurrence of HF Events | Trial comparisons |
| Tirzepatide - MTD vs Placebo: deaths from any cause | Trial comparisons |
| Tirzepatide - MTD vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT04847557/results?page=2