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

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Placebo controlled

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Elecoglipron 		Elecoglipron tablet once daily
  • Drug: Elecoglipron
    Elecoglipron tablet
Active Comparator
Placebo 		Placebo matching Elecoglipron tablet once daily
  • Drug: Placebo
    Placebo tablet

Recruiting Locations

Research Site
Fairhope, Alabama 36532

Research Site
Miami Lakes, Florida 33016

Research Site
Brooklyn, New York 11220

Research Site
Tomball, Texas 77375

Research Site
Redmond, Washington 98052

More Details

Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com