Heart Failure With Preserved Ejection Fraction (HFpEF), Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)
Conditions
Keywords
Heart failure, Elecoglipron
Brief 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.
Interventions
DRUGElecoglipron
Elecoglipron tablet
DRUGPlacebo
Placebo tablet
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit | Up to 42 months | Time to first event of the composite of: CV death HHF Urgent HF visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of elecoglipron compared with placebo in reducing the rate of HF events (HHF or urgent HF visit) | Up to 42 months | Total occurrences (first and recurrent) of HF events HHF Urgent HF visit |
| To evaluate the effect of elecoglipron compared to placebo on improving patient-reported outcomes using a questionnaire | Baseline and 52 weeks | Change from baseline to Week 52 |
| To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the 4-point composite of all-cause death, HHF, MI, or stroke | Up to 42 months | Time to first event of the composite of All-cause death HHF MI Stroke |
Countries
Argentina, Australia, Austria, Brazil, Canada, China, Czechia, Germany, Greece, Hungary, Italy, Japan, Malaysia, Netherlands, Poland, Romania, Slovakia, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States, Vietnam
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed