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
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?
Trial 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:.