RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT07761117

Registry updated: 2026-09-28

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Description

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.

Interventions

Elecoglipron (Drug)
Elecoglipron tablet
Placebo (Drug)
Placebo tablet

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.

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF) Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)

Locations

Research Site — Fairhope, Alabama, United States
Research Site — Anchorage, Alaska, United States
Research Site — Gilbert, Arizona, United States
Research Site — Sun City, Arizona, United States
Research Site — Beverly Hills, California, United States
Research Site — Huntington Beach, California, United States
Research Site — Huntington Park, California, United States
Research Site — Loma Linda, California, United States
Research Site — Lomita, California, United States
Research Site — Mather, California, United States
Research Site — Northridge, California, United States
Research Site — Palo Alto, California, United States
Research Site — Redding, California, United States
Research Site — San Diego, California, United States
Research Site — Tarzana, California, United States
Research Site — Colorado Springs, Colorado, United States
Research Site — New Haven, Connecticut, United States
Research Site — Bradenton, Florida, United States
Research Site — Hallandale, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Lakeland, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Miami, Florida, United States
Research Site — Miami Lakes, Florida, United States
Research Site — Miami Lakes, Florida, United States
Research Site — Ocala, Florida, United States
Research Site — Ocoee, Florida, United States
Research Site — Palmetto Bay, Florida, United States
Research Site — Riverview, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Columbus, Georgia, United States
Research Site — Tucker, Georgia, United States
Research Site — Champaign, Illinois, United States
Research Site — Chicago, Illinois, United States
Research Site — Gurnee, Illinois, United States
Research Site — Melrose Park, Illinois, United States
Research Site — Moline, Illinois, United States
Research Site — Niles, Illinois, United States
Research Site — Rockford, Illinois, United States
Research Site — Schaumburg, Illinois, United States
Research Site — Winfield, Illinois, United States
Research Site — Indianapolis, Indiana, United States
Research Site — Waterloo, Iowa, United States
Research Site — Leavenworth, Kansas, United States
Research Site — Wichita, Kansas, United States
Research Site — Owensboro, Kentucky, United States
Research Site — Bossier City, Louisiana, United States
Research Site — Covington, Louisiana, United States
Research Site — Lafayette, Louisiana, United States
Research Site — New Orleans, Louisiana, United States
Research Site — Shreveport, Louisiana, United States
Research Site — Zachary, Louisiana, United States
Research Site — Annapolis, Maryland, United States
Research Site — Baltimore, Maryland, United States
Research Site — Lanham, Maryland, United States
Research Site — Oxon Hill, Maryland, United States
Research Site — Boston, Massachusetts, United States
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Research Site — New Bedford, Massachusetts, United States
Research Site — Worcester, Massachusetts, United States
Research Site — Flint, Michigan, United States
Research Site — Southfield, Michigan, United States
Research Site — Southfield, Michigan, United States
Research Site — Troy, Michigan, United States
Research Site — Bridgeton, Missouri, United States
Research Site — Kansas City, Missouri, United States
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Research Site — Lincoln, Nebraska, United States
Research Site — Bridgewater, New Jersey, United States
Research Site — Millville, New Jersey, United States
Research Site — Sewell, New Jersey, United States
Research Site — Trenton, New Jersey, United States
Research Site — Vineland, New Jersey, United States
Research Site — Brooklyn, New York, United States
Research Site — Buffalo, New York, United States
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Research Site — Rosedale, New York, United States
Research Site — The Bronx, New York, United States
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Research Site — Chapel Hill, North Carolina, United States
Research Site — Durham, North Carolina, United States
Research Site — Greensboro, North Carolina, United States
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Research Site — Wilmington, North Carolina, United States
Research Site — Fargo, North Dakota, United States
Research Site — Grand Forks, North Dakota, United States
Research Site — Columbus, Ohio, United States
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Research Site — Dayton, Ohio, United States
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Research Site — Oklahoma City, Oklahoma, United States
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Research Site — Humble, Texas, United States
Research Site — Plano, Texas, United States
Research Site — San Antonio, Texas, United States
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Research Site — Tyler, Texas, United States
Research Site — Victoria, Texas, United States
Research Site — Burlington, Vermont, United States
Research Site — Arlington, Virginia, United States
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Research Site — Kingwood, West Virginia, United States
Research Site — Morgantown, West Virginia, United States
Research Site — Buenos Aires, Argentina
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Research Site — Wollongong, Australia
Research Site — Bad Ischl, Austria
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Research Site — Bragança Paulista, Brazil
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Research Site — Natal, Brazil
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Research Site — Huizhou, China
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Research Site — Jining, China
Research Site — Lanzhou, China
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Research Site — Luoyang, China
Research Site — Nanchang, China
Research Site — Nanjing, China
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Research Site — Nanyang, China
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Research Site — Panjin, China
Research Site — Pingxiang, China
Research Site — Qingzhou, China
Research Site — Sanya, China
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Research Site — Shanghai, China
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Research Site — Shantou, China
Research Site — Shaoguan, China
Research Site — Shaoxing, China
Research Site — Shenyang, China
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Research Site — Siping, China
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Research Site — Suzhou, China
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Research Site — Taian, China
Research Site — Tianjin, China
Research Site — Tianjin, China
Research Site — Ürümqi, China
Research Site — Wanzhou, China
Research Site — Weifang, China
Research Site — Wenzhou, China
Research Site — Wuhan, China
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Research Site — Wuxi, China
Research Site — Xi'an, China
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Research Site — Xuzhou, China
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Research Site — Yancheng, China
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Research Site — Yuncheng, China
Research Site — Zhangjiakou, China
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Research Site — Zibo, China
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Research Site — Zunyi, China
Research Site — Benešov, Czechia
Research Site — Boskovice, Czechia
Research Site — Brno, Czechia
Research Site — Broumov, Czechia
Research Site — Chlumec nad Cidlinou, Czechia
Research Site — Česká Lípa, Czechia
Research Site — Český Krumlov, Czechia
Research Site — Hradec Králové, Czechia
Research Site — Hustopeče, Czechia
Research Site — Jaroměř, Czechia
Research Site — Kadaň, Czechia
Research Site — Klatovy, Czechia
Research Site — Liberec, Czechia
Research Site — Louny, Czechia
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Research Site — Prague, Czechia
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Research Site — Teplice, Czechia
Research Site — Vsetín, Czechia
Research Site — Bron, France
Research Site — Corbeil-Essonnes, France
Research Site — La Tronche, France
Research Site — Le Coudray, France
Research Site — Lens, France
Research Site — Metz-Tessy, France
Research Site — Pau, France
Research Site — Rennes, France
Research Site — Rodez, France
Research Site — Rouen, France
Research Site — Saint-Brieuc, France
Research Site — Toulon, France
Research Site — Vandœuvre-lès-Nancy, France
Research Site — Bad Oldesloe, Germany
Research Site — Bamberg, Germany
Research Site — Berlin, Germany
Research Site — Berlin, Germany
Research Site — Berlin, Germany
Research Site — Bielefeld, Germany
Research Site — Bochum, Germany
Research Site — Bremen, Germany
Research Site — Chemnitz, Germany
Research Site — Cologne, Germany
Research Site — Dresden, Germany
Research Site — Elsterwerda, Germany
Research Site — Erlangen, Germany
Research Site — Essen, Germany
Research Site — Freiburg im Breisgau, Germany
Research Site — Gera, Germany
Research Site — Giessen, Germany
Research Site — Hamburg, Germany
Research Site — Hamburg, Germany
Research Site — Hamburg, Germany
Research Site — Hamburg, Germany
Research Site — Heidelberg, Germany
Research Site — Homburg, Germany
Research Site — Jena, Germany
Research Site — Kaiserslautern, Germany
Research Site — Karlsbad, Germany
Research Site — Kiel, Germany
Research Site — Ludwigshafen, Germany
Research Site — Ludwigshafen am Rhein, Germany
Research Site — Lüneburg, Germany
Research Site — Magdeburg, Germany
Research Site — Mainz, Germany
Research Site — Mainz, Germany
Research Site — Markkleeberg, Germany
Research Site — Mühldorf A. Inn, Germany
Research Site — Neuruppin, Germany
Research Site — Nuremberg, Germany
Research Site — Obertshausen, Germany
Research Site — Paderborn, Germany
Research Site — Papenburg, Germany
Research Site — Stuttgart, Germany
Research Site — Trier, Germany
Research Site — Tübingen, Germany
Research Site — Ulm, Germany
Research Site — Weyhe, Germany
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Athens, Greece
Research Site — Dragana, Greece
Research Site — Heraklion, Greece
Research Site — Heraklio, Greece
Research Site — Thessaloniki, Greece
Research Site — Voula, Greece
Research Site — Balatonfüred, Hungary
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Dunaújváros, Hungary
Research Site — Kaposvár, Hungary
Research Site — Miskolc, Hungary
Research Site — Nyíregyháza, Hungary
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Research Site — Belagavi, India
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Research Site — Coimbatore, India
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Research Site — Delhi, India
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Research Site — Jaipur, India
Research Site — Kanpur, India
Research Site — Kochi, India
Research Site — Kochi, India
Research Site — Kolkata, India
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Research Site — Ludhiana, India
Research Site — Meerut, India
Research Site — Mumbai, India
Research Site — Nagpur, India
Research Site — New Delhi, India
Research Site — Rudrapur, India
Research Site — Vadodara, India
Research Site — Ancona, Italy
Research Site — Bergamo, Italy
Research Site — Brescia, Italy
Research Site — Milan, Italy
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Research Site — Perugia, Italy
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Research Site — Aomori, Japan
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Research Site — Higashiibaraki-gun, Japan
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Research Site — Maebashi, Japan
Research Site — Matsusaka-shi, Japan
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Research Site — Gdynia, Poland
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Research Site — Katowice, Poland
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Research Site — Krakow, Poland
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Research Site — Poznan, Poland
Research Site — Przemyśl, Poland
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Research Site — Lučenec, Slovakia
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