Elecoglipron Compared With Placebo in Adults With Certain Types of Heart Failure
Tests elecoglipron against placebo for heart outcomes in adults with HFpEF or HFmrEF.
Plain-language title generated from the registry record
Registry title: A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF
Key facts
- Where
- Bialystok, Cracow, Częstochowa, Gdynia, Katowice, Krakow, Poznan, Przemyśl, Radzionkow, Skorzewo, Szczecin, Torun, Warsaw, Warszawa, and Wroclaw, PolandSee the 18 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with heart failure and a left ventricular ejection fraction above 40%. They take background dapagliflozin. They may or may not have type 2 diabetes. It compares elecoglipron with placebo.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Heart failure with preserved or mildly reduced ejection fraction (HFpEF or HFmrEF), NYHA Class II-IV, with left ventricular ejection fraction (LVEF) > 40% within 12 months before screening and evidence of structural heart disease
- Earlier treatment
- Must be on background dapagliflozin and other standard heart failure care
Main reasons for not taking part
- BMI below 25 kg/m² at screening
- Type 1 diabetes, or HbA1c ≥10% (86 mmol/mol) at screening
- History of acute or chronic pancreatitis
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Major cardiac surgery or procedure within 90 days before screening
Read by machine on 13 November 2026.
Where in Poland
- Kresmed Sp. z o. o.Bialystok, PolandTaking people
- Specderm Poznanska sp.j.Bialystok, PolandTaking people
- Unicardia Specjalistyczne Centrum Leczenia Chorob Serca I Naczyn & Unimedica Specjalistyczne Centrum Medyczne & Uniestetica Centrum Chirurgii Plastycznej Rekonstrukcyjnej I Medycyny Estetycznej Malopolskie Kliniki Specjalistyczne Sp. z o.o.Cracow, PolandTaking people
- Pratia S.A.Częstochowa, PolandTaking people
- Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii Lek. med. Krzysztof CymermanGdynia, PolandTaking people
- Pratia S.A.Gdynia, PolandTaking people
- Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W KatowicachKatowice, PolandTaking people
- Gyncentrum Sp. z o.o.Katowice, PolandTaking people
- Ewa Mirek-Bryniarska Specjalistyczna Praktyka LekarskaKrakow, PolandTaking people
- Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, PolandTaking people
- Wojewodzki Szpital im Sw Ojca Pio w PrzemysluPrzemyśl, PolandTaking people
- Tevita Clinical Sp. z o.o.Radzionkow, PolandTaking people
- Aidport sp z o.o.Skorzewo, PolandTaking people
- Osrodek Badan Klinicznych LabMed Sp. z o.o.Szczecin, PolandTaking people
- Medicover Integrated Clinical Services Sp. z o.o.Torun, PolandTaking people
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut BadawczyWarsaw, PolandTaking people
- Gabinet lekarski Maciej KarczWarszawa, PolandTaking people
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We WroclawiuWroclaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07761117EU 2026-526304-79-00
- Record updated
- 28 September 2026
- Original 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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; 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; 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; Diabetes exclusions:; History of type 1 diabetes; Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia; History of acute or chronic pancreatitis; History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening; HbA1c ≥10% at screening; On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening; BMI <25 kg/m² at screening; Renal exclusions:; Cardiovascular exclusions:; GI exclusions:; Endocrine exclusions:.