drugset / Trial / NCT04847557
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2021-04-20
- Primary completion
- 2024-07-02
- Completion
- 2024-07-02
Outcome
Met primary endpoint
registry Tirzepatide - MTD vs Placebo; p <0.001; Median Difference (Net) 6.9 (95% CI 3.3 to 10.6) NCT04847557 ↗
registry Tirzepatide - MTD vs Placebo; p = 0.026; Hazard Ratio (HR) 0.62 (95% CI 0.41 to 0.95) NCT04847557 ↗
release “today announced detailed results from the SUMMIT Phase 3 trial showing tirzepatide significantly reduced the risk of worsening heart failure events” lilly.com ↗
release “Both primary endpoints were met.” lilly.com ↗
Publications
- Borlaug BA, Zile MR, Kramer CM, Litwin SE, Ye W, Ou Y, Hurt K, Murakami M, Packer M; SUMMIT Trial Group. Effects of Tirzepatide in Obesity-Related HFpEF by Sex: A Prespecified Secondary Analysis From the SUMMIT Trial. JACC Heart Fail. 2026 Jul 7:103218. doi: 10.1016/j.jchf.2026.103218. Online ahead of print.
- Packer M, Zile MR, Kramer CM, DiMaria JM, Baum SJ, Litwin SE, Murakami M, Zhou C, Ou Y, Koeneman L, Borlaug BA; SUMMIT Trial Study Group. Influence of Type 2 Diabetes on the Effects of Tirzepatide in Patients With Heart Failure and a Preserved Ejection Fraction With Obesity: A Prespecified Stratification-Based Analysis. J Am Coll Cardiol. 2025 Sep 9;86(10):696-707. doi: 10.1016/j.jacc.2025.06.058.
- Borlaug BA, Zile MR, Kramer CM, Ye W, Ou Y, Hurt K, Murakami M, Packer M; SUMMIT Trial Study Group. Impact of Body Mass Index, Central Adiposity, and Weight Loss on the Benefits of Tirzepatide in HFpEF: The SUMMIT Trial. J Am Coll Cardiol. 2025 Jul 29;86(4):242-255. doi: 10.1016/j.jacc.2025.04.059.
- Packer M, Zile MR, Kramer CM, Murakami M, Ou Y, Borlaug BA; SUMMIT Trial Study Group. Interplay of Chronic Kidney Disease and the Effects of Tirzepatide in Patients With Heart Failure, Preserved Ejection Fraction, and Obesity: The SUMMIT Trial. J Am Coll Cardiol. 2025 May 13;85(18):1721-1735. doi: 10.1016/j.jacc.2025.03.009. Epub 2025 Mar 31.
- Kramer CM, Borlaug BA, Zile MR, Ruff D, DiMaria JM, Menon V, Ou Y, Zarante AM, Hurt KC, Murakami M, Packer M; SUMMIT Trial Study Group. Tirzepatide Reduces LV Mass and Paracardiac Adipose Tissue in Obesity-Related Heart Failure: SUMMIT CMR Substudy. J Am Coll Cardiol. 2025 Feb 25;85(7):699-706. doi: 10.1016/j.jacc.2024.11.001. Epub 2024 Nov 18.
- Zile MR, Borlaug BA, Kramer CM, Baum SJ, Litwin SE, Menon V, Ou Y, Weerakkody GJ, Hurt KC, Kanu C, Murakami M, Packer M; SUMMIT Trial Study Group. Effects of Tirzepatide on the Clinical Trajectory of Patients With Heart Failure, Preserved Ejection Fraction, and Obesity. Circulation. 2025 Mar 11;151(10):656-668. doi: 10.1161/CIRCULATIONAHA.124.072679. Epub 2024 Nov 18.
- Packer M, Zile MR, Kramer CM, Baum SJ, Litwin SE, Menon V, Ge J, Weerakkody GJ, Ou Y, Bunck MC, Hurt KC, Murakami M, Borlaug BA; SUMMIT Trial Study Group. Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity. N Engl J Med. 2025 Jan 30;392(5):427-437. doi: 10.1056/NEJMoa2410027. Epub 2024 Nov 16.
- Borlaug BA, Zile MR, Kramer CM, Baum SJ, Hurt K, Litwin SE, Murakami M, Ou Y, Upadhyay N, Packer M. Effects of tirzepatide on circulatory overload and end-organ damage in heart failure with preserved ejection fraction and obesity: a secondary analysis of the SUMMIT trial. Nat Med. 2025 Feb;31(2):544-551. doi: 10.1038/s41591-024-03374-z. Epub 2024 Nov 17.
- Reese-Petersen AL, Holm Nielsen S, Bulow Sand JM, Schattenberg JM, Bugianesi E, Karsdal MA. The sclerotic component of metabolic syndrome: Fibroblast activities may be the central common denominator driving organ function loss and death. Diabetes Obes Metab. 2024 Jul;26(7):2554-2566. doi: 10.1111/dom.15615. Epub 2024 May 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tirzepatide | Peptide | 5 mg | Subcutaneous |
| Subject | Tirzepatide | Peptide | 10 mg | Subcutaneous |
| Subject | Tirzepatide | Peptide | 15 mg | Subcutaneous |