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Clinical Trials in the UK / NCT07761117
Recruiting Phase 3

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

NCT07761117 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2026-08-24
Last updated
2026-09-09

Condition(s) studied

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

Investigational drug(s) / intervention(s)

ElecoglipronPlacebo

Elecoglipron: Elecoglipron tablet

Placebo: Placebo tablet

Study summary

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (672)

FacilityCityRegionStatus
Research Site Fairhope Alabama Recruiting
Research Site Anchorage Alaska Not Yet Recruiting
Research Site Gilbert Arizona Not Yet Recruiting
Research Site Surprise Arizona Not Yet Recruiting
Research Site Beverly Hills California Not Yet Recruiting
Research Site Huntington Beach California Not Yet Recruiting
Research Site Huntington Park California Not Yet Recruiting
Research Site Loma Linda California Not Yet Recruiting
Research Site Lomita California Not Yet Recruiting
Research Site Mather California Not Yet Recruiting
Research Site Northridge California Not Yet Recruiting
Research Site Palo Alto California Not Yet Recruiting
Research Site Redding California Not Yet Recruiting
Research Site San Diego California Not Yet Recruiting
Research Site Tarzana California Withdrawn
Research Site Colorado Springs Colorado Not Yet Recruiting
Research Site New Haven Connecticut Not Yet Recruiting
Research Site Bradenton Florida Withdrawn
Research Site Hallandale Florida Not Yet Recruiting
Research Site Jacksonville Florida Not Yet Recruiting
Research Site Lakeland Florida Not Yet Recruiting
Research Site Miami Florida Not Yet Recruiting
Research Site Miami Florida Not Yet Recruiting
Research Site Miami Florida Not Yet Recruiting
Research Site Miami Lakes Florida Withdrawn
Research Site Miami Lakes Florida Recruiting
Research Site Ocoee Florida Withdrawn
Research Site Palmetto Bay Florida Not Yet Recruiting
Research Site Riverview Florida Not Yet Recruiting
Research Site Atlanta Georgia Not Yet Recruiting
Research Site Columbus Georgia Not Yet Recruiting
Research Site Tucker Georgia Not Yet Recruiting
Research Site Champaign Illinois Withdrawn
Research Site Chicago Illinois Not Yet Recruiting
Research Site Gurnee Illinois Not Yet Recruiting
Research Site Melrose Park Illinois Not Yet Recruiting
Research Site Moline Illinois Not Yet Recruiting
Research Site Niles Illinois Not Yet Recruiting
Research Site Rockford Illinois Not Yet Recruiting
Research Site Schaumburg Illinois Not Yet Recruiting

+ 632 more sites — see the full list on the official registry below.

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07761117 on ClinicalTrials.gov ↗ ← All trials in the UK