Home › Heart Failure › NCT07761117
A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF
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)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Elecoglipron (drug)
- Placebo (drug)
Sponsor: AstraZeneca · Participants: 6,950 · Started: Aug 24, 2026
Contact the study team
- AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479
Official record on ClinicalTrials.gov — NCT07761117
Locations in the U.S.
| Alabama | Research Site, Fairhope |
| Alaska | Research Site, Anchorage (Not yet recruiting) |
| Arizona | Research Site, Gilbert (Not yet recruiting) Research Site, Sun City (Not yet recruiting) |
| California | Research Site, Beverly Hills (Not yet recruiting) Research Site, Huntington Beach (Not yet recruiting) Research Site, Huntington Park (Not yet recruiting) Research Site, Loma Linda (Not yet recruiting) Research Site, Lomita Research Site, Mather (Not yet recruiting) Research Site, Northridge (Not yet recruiting) Research Site, Palo Alto (Not yet recruiting) Research Site, Redding (Not yet recruiting) Research Site, San Diego (Not yet recruiting) |
| Colorado | Research Site, Colorado Springs (Not yet recruiting) |
| Connecticut | Research Site, New Haven (Not yet recruiting) |
| Florida | Research Site, Hallandale (Not yet recruiting) Research Site, Jacksonville (Not yet recruiting) Research Site, Lakeland (Not yet recruiting) Research Site, Miami (Not yet recruiting) Research Site, Miami (Not yet recruiting) Research Site, Miami (Not yet recruiting) Research Site, Miami Lakes Research Site, Ocala (Not yet recruiting) Research Site, Palmetto Bay (Not yet recruiting) Research Site, Riverview (Not yet recruiting) Research Site, Tampa (Not yet recruiting) |
| Georgia | Research Site, Atlanta (Not yet recruiting) Research Site, Columbus (Not yet recruiting) Research Site, Tucker (Not yet recruiting) |
| Illinois | Research Site, Chicago (Not yet recruiting) Research Site, Gurnee (Not yet recruiting) Research Site, Melrose Park (Not yet recruiting) Research Site, Moline (Not yet recruiting) Research Site, Niles (Not yet recruiting) Research Site, Rockford (Not yet recruiting) Research Site, Schaumburg (Not yet recruiting) Research Site, Winfield (Not yet recruiting) |
| Indiana | Research Site, Indianapolis (Not yet recruiting) |
| Iowa | Research Site, Waterloo (Not yet recruiting) |
| Kansas | Research Site, Leavenworth (Not yet recruiting) Research Site, Wichita (Not yet recruiting) |
| Kentucky | Research Site, Owensboro (Not yet recruiting) |
| Louisiana | Research Site, Bossier City (Not yet recruiting) Research Site, Covington (Not yet recruiting) Research Site, Lafayette (Not yet recruiting) Research Site, New Orleans (Not yet recruiting) Research Site, Shreveport (Not yet recruiting) Research Site, Zachary (Not yet recruiting) |
| Maryland | Research Site, Annapolis (Not yet recruiting) Research Site, Baltimore (Not yet recruiting) Research Site, Lanham (Not yet recruiting) Research Site, Oxon Hill (Not yet recruiting) |
| Massachusetts | Research Site, Boston (Not yet recruiting) Research Site, Boston (Not yet recruiting) Research Site, New Bedford (Not yet recruiting) |
| Michigan | Research Site, Flint Research Site, Southfield (Not yet recruiting) Research Site, Southfield (Not yet recruiting) Research Site, Troy (Not yet recruiting) |
| Missouri | Research Site, Bridgeton (Not yet recruiting) Research Site, Kansas City (Not yet recruiting) |
| Nebraska | Research Site, Lincoln (Not yet recruiting) |
| New Jersey | Research Site, Bridgewater (Not yet recruiting) Research Site, Millville (Not yet recruiting) Research Site, Sewell (Not yet recruiting) Research Site, Trenton (Not yet recruiting) Research Site, Vineland (Not yet recruiting) |
| New York | Research Site, Brooklyn Research Site, Buffalo (Not yet recruiting) Research Site, New York (Not yet recruiting) Research Site, New York (Not yet recruiting) Research Site, Rosedale (Not yet recruiting) Research Site, The Bronx (Not yet recruiting) Research Site, The Bronx |
| North Carolina | Research Site, Chapel Hill (Not yet recruiting) Research Site, Durham (Not yet recruiting) Research Site, Greensboro (Not yet recruiting) Research Site, Statesville (Not yet recruiting) Research Site, Wilmington (Not yet recruiting) |
| North Dakota | Research Site, Fargo (Not yet recruiting) Research Site, Grand Forks (Not yet recruiting) |
| Ohio | Research Site, Columbus (Not yet recruiting) Research Site, Dayton (Not yet recruiting) Research Site, Maumee (Not yet recruiting) |
| Oklahoma | Research Site, Oklahoma City (Not yet recruiting) |
| Pennsylvania | Research Site, Media (Not yet recruiting) Research Site, Philadelphia (Not yet recruiting) Research Site, Philadelphia (Not yet recruiting) Research Site, Smithfield (Not yet recruiting) Research Site, Yardley (Not yet recruiting) |
| Rhode Island | Research Site, East Providence (Not yet recruiting) |
| South Carolina | Research Site, Spartanburg (Not yet recruiting) |
| South Dakota | Research Site, Rapid City (Not yet recruiting) |
| Texas | Research Site, Dallas (Not yet recruiting) Research Site, DeSoto (Not yet recruiting) Research Site, El Paso (Not yet recruiting) Research Site, Houston (Not yet recruiting) Research Site, Houston (Not yet recruiting) Research Site, Humble Research Site, San Antonio (Not yet recruiting) Research Site, San Antonio (Not yet recruiting) Research Site, Tomball Research Site, Tyler (Not yet recruiting) Research Site, Victoria (Not yet recruiting) |
| Virginia | Research Site, Arlington (Not yet recruiting) |
| Washington | Research Site, Redmond |
| West Virginia | Research Site, Kingwood (Not yet recruiting) Research Site, Morgantown (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.