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A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF

NCT07761117 · AstraZeneca
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Official title
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants With HFpEF and HFmrEF (Elevate-HF)
About this study
This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of T2DM status, and who are on background dapagliflozin in addition to other background standard of care.
Eligibility criteria
Inclusion Criteria: * Left ventricular ejection fraction (LVEF) of \> 40% within 12 months prior to screening. * Structural heart disease evidence. * HF diagnosed with New York Heart Association (NYHA) Class II-IV at the time of screening. Exclusion Criteria: * BMI \<25 kg/m² at screening. * Diabetes exclusions: * History of type 1 diabetes. * HbA1c ≥10% at screening. * Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema. * more than 1 episode of severe hypoglycemic event within 180 days prior to screening, or hypoglycemia unawareness/poor recognition. * Renal exclusions: * On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening * Cardiovascular exclusions: * Major cardiac surgery, coronary revascularization, valvular repair/replacement, AF/AFL ablation, CRT implantation, or ICD without CRT within 90 days prior to screening, or planned after randomization. * Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia. * GI exclusions: * Clinically significant upper GI condition affecting gastric emptying, drug absorption, or safety/tolerability interpretation; chronic use of drugs directly affecting GI motility; severe disease or prior surgery. * History of acute or chronic pancreatitis. * Endocrine exclusions: * History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening.
Study design
Enrollment target: 6950 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-08-24
Estimated completion: 2029-09-03
Last updated: 2026-09-09
Interventions
Drug: ElecoglipronDrug: Placebo
Primary outcomes
  • To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit (Up to 42 months)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
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Kobe, Japan
Research SiteNot Yet Recruiting
Kobe, Japan
Research SiteNot Yet Recruiting
Kobe, Japan
Research SiteNot Yet Recruiting
Kure-shi, Japan
Research SiteNot Yet Recruiting
Kyoto, Japan
Research SiteNot Yet Recruiting
Kyoto, Japan
Research SiteNot Yet Recruiting
Maebashi, Japan
Research SiteNot Yet Recruiting
Matsusaka-shi, Japan
Research SiteNot Yet Recruiting
Minatoku, Japan
Research SiteRecruiting
Mito, Japan
Research SiteNot Yet Recruiting
Morioka, Japan
Research SiteNot Yet Recruiting
Nagasaki, Japan
Research SiteNot Yet Recruiting
Nagoya, Japan
Research SiteNot Yet Recruiting
Nagoya, Japan
Research SiteNot Yet Recruiting
Nagoya, Japan
Research SiteWithdrawn
Osaka, Japan
Research SiteNot Yet Recruiting
Ōmihachiman, Japan
Research SiteNot Yet Recruiting
Sagamihara-shi, Japan
Research SiteRecruiting
Sapporo, Japan
Research SiteNot Yet Recruiting
Sayama-shi,, Japan
Research SiteNot Yet Recruiting
Sendai, Japan
Research SiteNot Yet Recruiting
Shibuya-ku, Japan
Research SiteWithdrawn
Shizuoka, Japan
Research SiteNot Yet Recruiting
Shizuoka, Japan
Research SiteNot Yet Recruiting
Suginami City, Japan
Research SiteNot Yet Recruiting
Suita, Japan
Research SiteNot Yet Recruiting
Suzuka-shi, Japan
Research SiteNot Yet Recruiting
Tachikawa-shi, Japan
Research SiteNot Yet Recruiting
Takaoka-shi, Japan
Research SiteNot Yet Recruiting
Takatsuki-shi, Japan
Research SiteNot Yet Recruiting
Tokushima, Japan
Research SiteNot Yet Recruiting
Toshima-ku, Japan
Research SiteNot Yet Recruiting
Toyama, Japan
Research SiteNot Yet Recruiting
Ueda-shi, Japan
Research SiteNot Yet Recruiting
Urasoe-Shi, Japan
Research SiteNot Yet Recruiting
Urayasu-shi, Japan
Research SiteNot Yet Recruiting
Uruma, Japan
Research SiteNot Yet Recruiting
Utsunomiya, Japan
Research SiteNot Yet Recruiting
Wakayama, Japan
Research SiteNot Yet Recruiting
Yakushi, Japan
Research SiteNot Yet Recruiting
Yokohama, Japan
Research SiteNot Yet Recruiting
Yokohama, Japan
Research SiteNot Yet Recruiting
Yokohama, Japan
Research SiteNot Yet Recruiting
Yokohama, Japan
Research SiteNot Yet Recruiting
Alor Star, Malaysia
Research SiteNot Yet Recruiting
Cheras, Malaysia
Research SiteNot Yet Recruiting
Kajang, Malaysia
Research SiteNot Yet Recruiting
Kuala Lumpur, Malaysia
Research SiteNot Yet Recruiting
Kuala Lumpur, Malaysia
Research SiteNot Yet Recruiting
Kuala Lumpur, Malaysia
Research SiteNot Yet Recruiting
Kuala Terengganu, Malaysia
Research SiteNot Yet Recruiting
Kuantan, Malaysia
Research SiteNot Yet Recruiting
Kuching, Malaysia
Research SiteNot Yet Recruiting
Miri, Malaysia
Research SiteNot Yet Recruiting
Sungai Buloh, Malaysia
Research SiteNot Yet Recruiting
Guadalajara, Mexico
Research SiteNot Yet Recruiting
México, Mexico
Research SiteNot Yet Recruiting
México, Mexico
Research SiteNot Yet Recruiting
Monterrey, Mexico
Research SiteNot Yet Recruiting
Monterrey, Mexico
Research SiteNot Yet Recruiting
Monterrey, Mexico
Research SiteNot Yet Recruiting
Querétaro, Mexico
Research SiteNot Yet Recruiting
San Luis Potosí City, Mexico
Research SiteWithdrawn
Tijuana, Mexico
Research SiteNot Yet Recruiting
Xalapa, Mexico
Research SiteNot Yet Recruiting
Zapopan, Mexico
Research SiteNot Yet Recruiting
Alkmaar, Netherlands
Research SiteNot Yet Recruiting
Almere Stad, Netherlands
Research SiteNot Yet Recruiting
Amstelveen, Netherlands
Research SiteNot Yet Recruiting
Doetinchem, Netherlands
Research SiteNot Yet Recruiting
Leeuwarden, Netherlands
Research SiteNot Yet Recruiting
Rotterdam, Netherlands
Research SiteNot Yet Recruiting
Sneek, Netherlands
Research SiteNot Yet Recruiting
The Hague, Netherlands
Research SiteNot Yet Recruiting
Tilburg, Netherlands
Research SiteNot Yet Recruiting
Zutphens, Netherlands
Research SiteNot Yet Recruiting
Zwolle, Netherlands
Research SiteNot Yet Recruiting
Bialystok, Poland
Research SiteNot Yet Recruiting
Bialystok, Poland
Research SiteNot Yet Recruiting
Częstochowa, Poland
Research SiteNot Yet Recruiting
Gdynia, Poland
Research SiteNot Yet Recruiting
Gdynia, Poland
Research SiteNot Yet Recruiting
Katowice, Poland
Research SiteNot Yet Recruiting
Katowice, Poland
Research SiteSuspended
Krakow, Poland
Research SiteNot Yet Recruiting
Krakow, Poland
Research SiteNot Yet Recruiting
Krakow, Poland
Research SiteNot Yet Recruiting
Poznan, Poland
Research SiteNot Yet Recruiting
Przemyśl, Poland
Research SiteNot Yet Recruiting
Radzionków, Poland
Research SiteNot Yet Recruiting
Skórzewo, Poland
Research SiteNot Yet Recruiting
Szczecin, Poland
Research SiteNot Yet Recruiting
Torun, Poland
Research SiteNot Yet Recruiting
Warsaw, Poland
Research SiteNot Yet Recruiting
Warsaw, Poland
Research SiteNot Yet Recruiting
Wroclaw, Poland
Research SiteNot Yet Recruiting
Włocławek, Poland
Research SiteNot Yet Recruiting
Baia Mare, Romania
Research SiteNot Yet Recruiting
Brasov, Romania
Research SiteNot Yet Recruiting
Bucharest, Romania
Research SiteNot Yet Recruiting
Bucharest, Romania
Research SiteNot Yet Recruiting
Bucharest, Romania
Research SiteNot Yet Recruiting
Craiova, Romania
Research SiteNot Yet Recruiting
Satu Mare, Romania
Research SiteNot Yet Recruiting
Timișoara, Romania
Research SiteNot Yet Recruiting
Timișoara, Romania
Research SiteNot Yet Recruiting
Timișoara, Romania
Research SiteNot Yet Recruiting
Bratislava, Slovakia
Research SiteWithdrawn
Bratislava, Slovakia
Research SiteNot Yet Recruiting
Bratislava, Slovakia
Research SiteNot Yet Recruiting
Brezno, Slovakia
Research SiteNot Yet Recruiting
Košice, Slovakia
Research SiteNot Yet Recruiting
Košice, Slovakia
Research SiteNot Yet Recruiting
Lučenec, Slovakia
Research SiteNot Yet Recruiting
Lučenec, Slovakia
Research SiteNot Yet Recruiting
Nitra, Slovakia
Research SiteNot Yet Recruiting
Prešov, Slovakia
Research SiteNot Yet Recruiting
Svidník, Slovakia
Research SiteNot Yet Recruiting
Šahy, Slovakia
Research SiteNot Yet Recruiting
Busan, South Korea
Research SiteNot Yet Recruiting
Busan, South Korea
Research SiteNot Yet Recruiting
Daegu, South Korea
Research SiteNot Yet Recruiting
Daejeon, South Korea
Research SiteNot Yet Recruiting
Gwangju, South Korea
Research SiteNot Yet Recruiting
Gyeonggi-do, South Korea
Research SiteNot Yet Recruiting
Incheon, South Korea
Research SiteNot Yet Recruiting
Incheon, South Korea
Research SiteNot Yet Recruiting
Seongbuk-Gu, South Korea
Research SiteNot Yet Recruiting
Seoul, South Korea
Research SiteNot Yet Recruiting
Seoul, South Korea
Research SiteNot Yet Recruiting
Seoul, South Korea
Research SiteNot Yet Recruiting
Seoul, South Korea
Research SiteNot Yet Recruiting
Seoul, South Korea
Research SiteNot Yet Recruiting
Suwon, South Korea
Research SiteNot Yet Recruiting
Uijeongbu-si, South Korea
Research SiteNot Yet Recruiting
Yangsan, South Korea
Research SiteNot Yet Recruiting
Barcelona, Spain
Research SiteNot Yet Recruiting
Barcelona, Spain
Research SiteNot Yet Recruiting
Barcelona, Spain
Research SiteNot Yet Recruiting
Jaén, Spain
Research SiteNot Yet Recruiting
Madrid, Spain
Research SiteNot Yet Recruiting
Madrid, Spain
Research SiteNot Yet Recruiting
Murcia, Spain
Research SiteNot Yet Recruiting
Salamanca, Spain
Research SiteNot Yet Recruiting
Sanlúcar de Barrameda (Cádiz), Spain
Research SiteNot Yet Recruiting
Seville, Spain
Research SiteNot Yet Recruiting
Valencia, Spain
Research SiteNot Yet Recruiting
Valencia, Spain
Research SiteNot Yet Recruiting
Valencia, Spain
Research SiteNot Yet Recruiting
Villamartín, Spain
Research SiteNot Yet Recruiting
Gothenburg, Sweden
Research SiteNot Yet Recruiting
Jönköping, Sweden
Research SiteNot Yet Recruiting
Karlstad, Sweden
Research SiteNot Yet Recruiting
Lund, Sweden
Research SiteNot Yet Recruiting
Mölndal, Sweden
Research SiteNot Yet Recruiting
Örebro, Sweden
Research SiteNot Yet Recruiting
Stockholm, Sweden
Research SiteNot Yet Recruiting
Stockholm, Sweden
Research SiteWithdrawn
Stockholm, Sweden
Research SiteNot Yet Recruiting
Stockholm, Sweden
Research SiteNot Yet Recruiting
Uppsala, Sweden
Research SiteNot Yet Recruiting
Kaohsiung City, Taiwan
Research SiteNot Yet Recruiting
New Taipei City, Taiwan
Research SiteNot Yet Recruiting
New Taipei City, Taiwan
Research SiteNot Yet Recruiting
Taichung, Taiwan
Research SiteNot Yet Recruiting
Taichung, Taiwan
Research SiteNot Yet Recruiting
Taichung, Taiwan
Research SiteNot Yet Recruiting
Taipei, Taiwan
Research SiteNot Yet Recruiting
Taipei, Taiwan
Research SiteWithdrawn
Taipei, Taiwan
Research SiteNot Yet Recruiting
Taipei, Taiwan
Research SiteNot Yet Recruiting
Taipei, Taiwan
Research SiteNot Yet Recruiting
Taipei, Taiwan
Research SiteNot Yet Recruiting
Taoyuan, Taiwan
Research SiteNot Yet Recruiting
Yilan, Taiwan
Research SiteNot Yet Recruiting
Bangkok, Thailand
Research SiteNot Yet Recruiting
Bangkok, Thailand
Research SiteNot Yet Recruiting
Bangkok, Thailand
Research SiteNot Yet Recruiting
Changwat Sara Buri, Thailand
Research SiteNot Yet Recruiting
Chiang Mai, Thailand
Research SiteNot Yet Recruiting
Hat Yai, Thailand
Research SiteNot Yet Recruiting
Khlong Luang, Thailand
Research SiteNot Yet Recruiting
Khon Kaen, Thailand
Research SiteNot Yet Recruiting
Phitsanulok, Thailand
Research SiteNot Yet Recruiting
Ratchaburi, Thailand
Research SiteNot Yet Recruiting
Adana, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Ankara, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Antalya, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Center, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Center, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Istanbul, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Izmir, Turkey (Türkiye)
Research SiteWithdrawn
Kahramanmaraş, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Kütahya, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Odunpazari, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Odunpazari, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Yenimahalle, Turkey (Türkiye)
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Kyiv, Ukraine
Research SiteNot Yet Recruiting
Lviv, Ukraine
Research SiteNot Yet Recruiting
Uzhhorod, Ukraine
Research SiteNot Yet Recruiting
Uzhhorod, Ukraine
Research SiteNot Yet Recruiting
Abo Dhabi, United Arab Emirates
Research SiteNot Yet Recruiting
Abu Dhabi, United Arab Emirates
Research SiteNot Yet Recruiting
Abu Dhabi, United Arab Emirates
Research SiteNot Yet Recruiting
Ashton-under-Lyne, United Kingdom
Research SiteNot Yet Recruiting
Basildon, United Kingdom
Research SiteNot Yet Recruiting
Belfast, United Kingdom
Research SiteNot Yet Recruiting
Birmingham, United Kingdom
Research SiteNot Yet Recruiting
Brighton, United Kingdom
Research SiteNot Yet Recruiting
Bristol, United Kingdom
Research SiteNot Yet Recruiting
Cardiff, United Kingdom
Research SiteNot Yet Recruiting
Clydebank, United Kingdom
Research SiteNot Yet Recruiting
Dundee, United Kingdom
Research SiteNot Yet Recruiting
Glasgow, United Kingdom
Research SiteNot Yet Recruiting
Kings Lynn, United Kingdom
Research SiteNot Yet Recruiting
Leeds, United Kingdom
Research SiteNot Yet Recruiting
London, United Kingdom
Research SiteNot Yet Recruiting
Sandbach, United Kingdom
Research SiteNot Yet Recruiting
Southampton, United Kingdom
Research SiteNot Yet Recruiting
Woodbridge, United Kingdom
Research SiteNot Yet Recruiting
Can Tho, Vietnam
Research SiteNot Yet Recruiting
Hanoi, Vietnam
Research SiteNot Yet Recruiting
Hà Nội, Vietnam
Research SiteNot Yet Recruiting
Ho Chi Minh City, Vietnam
Research SiteWithdrawn
Ho Chi Minh City, Vietnam
Research SiteNot Yet Recruiting
Ho Chi Minh City, Vietnam
Research SiteNot Yet Recruiting
Hochiminh City, Vietnam
Research SiteNot Yet Recruiting
Hochiminh, Vietnam