Granted Patent
B2
US 12,551,534 · App. 17/795,972 · Granted Feb 17, 2026
Therapeutic uses of tirzepatide
Inventors:
Axel Haupt (Zionsville, IN); Masahiro Murakami (Carmel, IN); Jeffrey Scott Riesmeyer (Fishers, IN)
Assignee:
ELI LILLY AND COMPANY
View Patent ↗
Loading inventors, assignments & file history…
Abstract
The present invention relates to methods for treating, preventing or delaying disorders relating to cognition, such as cognitive decline, cognitive impairment or dementia. The present invention also relates to method for treating, preventing or delaying heart failure, such as heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF).
Claims (8)
1 . A method of treating heart failure with preserved ejection fraction (HFpEF) in a patient with obesity, comprising administering an effective amount of tirzepatide, or a pharmaceutically acceptable salt thereof, to the patient once weekly.
2 . The method of claim 1 , wherein the patient's risk of the occurrence of a composite of the following outcomes is reduced: cognitive decline, hospitalization for HFpEF, or death.
3 . The method of claim 1 wherein the therapeutically effective amount of tirzepatide is selected from the group consisting of about 5.0 mg, about 10.0 mg and about 15.0 mg.
4 . The method of claim 1 , wherein the therapeutically effective amount of tirzepatide is about 15.0 mg.
5 . The method of claim 1 wherein once weekly administration of tirzepatide is continued for at least 2 years.
6 . The method of claim 1 , wherein the therapeutically effective amount of tirzepatide is about 5.0 mg.
7 . The method of claim 1 , wherein the therapeutically effective amount of tirzepatide is about 10.0 mg.
8 . The method of claim 1 , wherein the patient has type 2 diabetes mellitus.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jul 28, 2022
From: COGHLAN, MATTHEW PAUL; HAUPT, AXEL; MURAKAMI, MASAHIRO; RIESMEYER, JEFFREY SCOTT
To: ELI LILLY AND COMPANY
Reel/Frame 060656/0581 →
Continuity (2)
Provisional Application
62967867
· Jan 30, 2020
References Cited (50)
US 9474780B2
· Bokvist et al.
· 2016
[cited by applicant]
US 20100029554A1
· Ghosh et al.
· 2010
[cited by applicant]
US 20130065828A1
· Ruus et al.
· 2013
[cited by applicant]
US 20160151461A1
· Shannon
· 2016
[cited by applicant]
US 20200023040A1
· Benson et al.
· 2020
[cited by applicant]
WO 2013164483A1
· 2013
[cited by applicant]
WO 2014005858A1
· 2014
[cited by applicant]
WO 2015067715A2
· 2015
[cited by applicant]
WO 2020261205A1
· 2020
[cited by applicant]
WO 2022271611A1
· 2022
[cited by applicant]
Bizino, M. et al., Cardiovascular Diabetology, “Effect of liraglutide on cardiac function in patients with type 2 diabetes mellitus: randomized placebo-controlled trial”, Apr. 2019, vol. 18:55, 12 pages (Year: 2019).
[cited by examiner]
American Heart Association, “What is Cardiovascular Disease”, last reviewed Jan. 10, 2024, available at https://www.heart.org/en/health-topics/consumer-healthcare/what-is-cardiovascular-disease# (Year: 2024).
[cited by examiner]
American Heart Association, “Ejection Fraction Heart Failure Measurement”, last reviewed May 30, 2025, available at https://www.heart.org/en/health-topics/heart-failure/diagnosing-heart-failure/ejection-fraction-heart-f…
[cited by examiner]
Del Olmo-Garcia, M. et al., Journal of Diabetes Research, “GLP-1 Receptor Agonists and Cardiovascular Disease in Patients with Type 2 Diabetes”, 2018, 12 pages (Year: 2018).
[cited by examiner]
Scheen, Andre, Diabetes & Metabolism, “GLP-1 receptor agonists and heart failure in diabetes”, 2017, vol. 43, pp. 2S13-2S19 (Year: 2017).
[cited by examiner]
Temporelli, Pier Luigi, “European Heart Journal Supplements, Role of glucagon-like peptide-1 agonists in obesity and heart failure with preserved ejection fraction”, 2024, vol. 26, supplement 1, i127-i130 (Year: 2024).
[cited by examiner]
International Search Report of the International Searching Authority pertaining to International Application No. PCT/US2021/014535; Date of Mailing: Jul. 9, 2021; 7 pages.
[cited by applicant]
Written Opinion of the International Searching Authority pertaining to International Application No. PCT/US2021/014535; Date of Mailing: Jul. 9, 2021; 6 pages.
[cited by applicant]
Bastin et at , Dual GIP-GLP1-Receptor Agonists In The Treatment Of Type 2 Diabetes: A Short Review On Emerging Data And Therapeutic Potential Diabetes Metab Syndr Obes. 2019, vol. 12, p. 1973-1985. Entire documentation …
[cited by applicant]
Coskun at at., LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. Mol Metab. 2018, vol. 18, p. 3-14. Entire documentation e…
[cited by applicant]
Mathiesen et al., The Eects of Dual GLP-1/GIP Receptor Agonism on Glucagon Secretion—A Review Int J Mol Sal 2019, vol. 20(17): 4092. PDF File. p. 118. Abstract; p. 8, pare 5 and last para; p. 9; and p. 10, para 2.
[cited by applicant]
Saedi at al., Diabetes mellitus and cognitive Impairments. World J Diabetes 2016, vol. 7(17), p. 412-422 Abstract; p. 412, col. 2, last para, p. 413, col. 2, para 5 and last para; p. 415, col. 1, para 3; and p. 416, col…
[cited by applicant]
Willard at at., Tirzepatide is an imbalanced and biased dual GIP and GLP-1 receptor agonist. JCI Insight Sep. 2020, vol. 5(17): e140532 PDF File: p. 1-16 Entire documentation especially Abstract.
[cited by applicant]
Frias, at at., “Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised, placebo-controlled and active comparator-controlled phase 2 trial”, The Lanc…
[cited by applicant]
Mansur, et al., “Cognitive dysfunction and metabolic comorbities in mood disorders: A repurposing opportunity for glucagon-like peptide 1 receptor agonists?” Neuropharmacology, Elsevier, 2018, 9 pages.
[cited by applicant]
Aggarwal, Rahul, et al., “Effect of sotagliflozin on major adverse cardiovascular events: a prespecified secondary analysis of the SCORED randomised trial”, The Lancet, Apr. 2025, vol. 13, 321-333.
[cited by applicant]
Baser, Onur, et al., “The association between weight loss medications and cardiovascular complications”, The Obesity Society, Wiley, 2024, 32, 1401-1409.
[cited by applicant]
Borlaug, Barry A., et al., “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”, Nature Medicine, …
[cited by applicant]
Extended EP Search Report, EP 21748068.0, mailed date Jan. 30, 2024, 21 pages.
[cited by applicant]
Holscher, Christian, “Novel dual GLP-1/GIP agonist show neuroprotective effects in Alzheimer's and Parkinson's disease models”, Neuropharmacology, Elsevier, 2018, 251-259.
[cited by applicant]
NCT03861052: Clinical Study Protocl Amendment Version (a) I8F-JE-GPGO A Phase 3 Study of Tirzepatide Monotherapy Compared to Dulaglutide 0.75 mg in Patients with Type 2 Diabetes Mellitus (SURPASS J-mono) Jan. 17, 2019, …
[cited by applicant]
Packer, Milton, et al., “Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity”, The New England Journal of Medicine, Jan. 30, 2025, vol. 392 No. 5, 427-437.
[cited by applicant]
Rosenstock, Julio, et al., “Efficacy and Safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes”, The Lancet, vol. 398, Jul. 10, 2021, 143-155.
[cited by applicant]
Saglietto, Andrea, et al., “Glucagon-like peptide-1 receptor agonist semaglutide reduces atrial fibrillation incidence: A systematic review and meta-analysis”, Wiley, May 2024, 1-10.
[cited by applicant]
Shi, Lijuan, et al., “A Novel Dual GLP-1/GIP agonist alleviates cognitive decline by re-sensitizing insulin signaling in the Alzheimer icv. STZ rat model”, Behavioural Brain Research, Elsevier, 2017, 65-74.
[cited by applicant]
Verma, Subodh, et al., “Atrial Fibrillation and Semaglutide Effects in Obesity-Related Heart Failure With Preserved Ejection Fraction”, Journal of The American College of Cardiology, 2024, vol. 84, No. 17, 1603-1614.
[cited by applicant]
Zhang, Hong-Da, et al., “Semaglutide for the prevention of atrial fibrillation: A systematic review and meta-analysis”, Diabetes & Metabolic Syndrome: Clinical Research & Reviews, Elsevier, Jun. 2024, 1-9.
[cited by applicant]
McMurray, J.J.V., et al., “Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction”, The New England Journal of Medicine, vol. 381, No. 21, Nov. 21, 2019, 1995-2008.
[cited by applicant]
Nguyen, T. Dung, et al., “GLP-1 Improves Diastolic Function and Survival in Heart Failure with Preserved Ejection Fraction”, Journal of Cardiovascular Translational Research, 2018, 11, 259-267.
[cited by applicant]
Oyama, J., et al., “Incretin Therapy and Heart Failure”, Official Journal of the Japanese Circulation Society, vol. 78, Apr. 2014, 819-824.
[cited by applicant]
Sokos, G.G., et al., “Glucagon-Like Peptide-1 Infusion Improves Left Ventricular Ejection Fraction and Functional Status in Patients With Chronic Heart Failure”, Journal of Cardiac Failure vol. 12 No. 9 2006, 694-699.
[cited by applicant]