On 16 November 2024 at the 100th American Heart Association (AHA) Scientific Sessions in Chicago, Illinois, US, results were presented from the SUMMIT trial (NCT04847557), which evaluated the impact of Eli Lilly’s tirzepatide in patients with obesity and heart failure with preserved ejection fraction (HFpEF) on major heart failure outcomes.

Tirzepatide is a long-acting dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GIP/GLP-1). In addition to tirzepatide’s application in obesity and type 2 diabetes (T2D), it is also in pre-registration for obstructive sleep apnea, in Phase III for cardiovascular risk factors and HFpEF, and in Phase II for metabolic dysfunction-associated steatohepatitis and chronic kidney disease.

The SUMMIT trial comprised two arms: the experimental arm (n=364) involved subjects receiving tirzepatide, starting treatment at a once-weekly 2.5mg dose that followed a fixed-dose escalation regimen in which doses were increased every four weeks by 2.5mg until the maintenance dose of 15mg/week was reached by 20 weeks. The second arm of the trial was the placebo arm (n=367). The final primary endpoints of SUMMIT were a combination of adjudicated cardiovascular mortality or a worsening heart failure event (α = 0.04) and a change in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline to 52 weeks (α = 0.01). Key secondary endpoints included changes in body weight, 6-minute walk distance and high sensitivity C-reactive protein (hsCRP).

Milton Packer MD, distinguished scholar in cardiovascular science at Baylor University Medical Center Dallas and visiting professor at Imperial College London, reported the results of the SUMMIT trial concerning the efficacy and safety of tirzepatide for the treatment of obesity-related HFpEF. On the primary endpoints of the study, combined cardiovascular mortality and worsening heart failure events (α = 0.04) were determined in 36 patients (9.9%) in the tirzepatide group, whereas in the placebo group, such events were reported in 56 patients (15.3%) (p=0.026). As for the mean (±SD) change in KCCQ-CSS – in the tirzepatide group, this was 19.5±1.2 and in the placebo group 12.7±1.3. The median difference in KCCQ-CSS between the tirzepatide and placebo arms of the study was 6.9 (3.3 to 10.6) (p<0.001). Secondary endpoints of the study, including change in 6-minute walk distance scores and systemic inflammation, were significantly and meaningfully improved with tirzepatide. As for the safety profile of tirzepatide in SUMMIT, results were comparable to those of previous clinical trials; 4% of the experimental group discontinued treatment as a result of gastrointestinal symptoms.

A highly anticipated treatment for HFpEF patients

Key opinion leaders (KOLs) interviewed by GlobalData state that while GLP-1RAs have proven benefits in T2D and obesity, the patient’s weight is not the only issue that matters; cardiovascular disease outcome studies are of utmost significance. KOLs additionally emphasised the importance of educating patients on weight management and cardiovascular disease.

Tirzepatide has the potential to be popular among HFpEF patients and clinicians alike, given its ability to reduce the combined risk of cardiovascular mortality and worsening heart failure and treat patients with HFpEF and obesity. It is on a trajectory to provide a highly anticipated treatment for HFpEF patients.  

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

View profiles in store

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData

Submit

UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo

Industry * Academia & Education Aerospace, Defense & Security Agriculture Asset Management Automotive Banking & Payments Chemicals Construction Consumer Foodservice Government, trade bodies and NGOs Health & Fitness Hospitals & Healthcare HR, Staffing & Recruitment Insurance Investment Banking Legal Services Management Consulting Marketing & Advertising Media & Publishing Medical Devices Mining Oil & Gas Packaging Pharmaceuticals Power & Utilities Private Equity Real Estate Retail Sport Technology Telecom Transportation & Logistics Travel, Tourism & Hospitality Venture Capital

Tick here to opt out of curated industry news, reports, and event updates from Pharmaceutical Technology.

Submit and download

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

According to GlobalData’s Pharma Intelligence Center, there are 6 Phase III candidates, 12 Phase II candidates and 8 Phase I candidates for HFpEF globally. There are 20 Phase III candidates, 70 Phase II candidates, and 91 Phase I candidates for obesity globally.