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

6950 patients around the world

Available in Argentina, Brazil, United States

AstraZeneca

6950Patients around the world

This study is for people with

Heart failure

From 18 Years

All Gender

: 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.

: 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.

StudyElevate-HF

SponsorAstraZeneca

Study typeInterventional

Conditions

Heart failure

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07761117