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
- Abo Dhabi and Abu Dhabi, United Arab EmiratesSee the 2 sites
- Phase
- Phase 3
Where in United Arab Emirates
- Abo DhabiAbo Dhabi, United Arab EmiratesNot yet recruiting
- Abu DhabiAbu Dhabi, United Arab EmiratesNot yet recruiting
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:.