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

RecruitingPhase 3

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

Sponsor: AstraZeneca · Participants: 6,950 · Started: Aug 24, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07761117

Locations in the U.S.

AlabamaResearch Site, Fairhope
AlaskaResearch Site, Anchorage (Not yet recruiting)
ArizonaResearch Site, Gilbert (Not yet recruiting)
Research Site, Sun City (Not yet recruiting)
CaliforniaResearch 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)
ColoradoResearch Site, Colorado Springs (Not yet recruiting)
ConnecticutResearch Site, New Haven (Not yet recruiting)
FloridaResearch 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)
GeorgiaResearch Site, Atlanta (Not yet recruiting)
Research Site, Columbus (Not yet recruiting)
Research Site, Tucker (Not yet recruiting)
IllinoisResearch 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)
IndianaResearch Site, Indianapolis (Not yet recruiting)
IowaResearch Site, Waterloo (Not yet recruiting)
KansasResearch Site, Leavenworth (Not yet recruiting)
Research Site, Wichita (Not yet recruiting)
KentuckyResearch Site, Owensboro (Not yet recruiting)
LouisianaResearch 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)
MarylandResearch Site, Annapolis (Not yet recruiting)
Research Site, Baltimore (Not yet recruiting)
Research Site, Lanham (Not yet recruiting)
Research Site, Oxon Hill (Not yet recruiting)
MassachusettsResearch Site, Boston (Not yet recruiting)
Research Site, Boston (Not yet recruiting)
Research Site, New Bedford (Not yet recruiting)
MichiganResearch Site, Flint
Research Site, Southfield (Not yet recruiting)
Research Site, Southfield (Not yet recruiting)
Research Site, Troy (Not yet recruiting)
MissouriResearch Site, Bridgeton (Not yet recruiting)
Research Site, Kansas City (Not yet recruiting)
NebraskaResearch Site, Lincoln (Not yet recruiting)
New JerseyResearch 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 YorkResearch 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 CarolinaResearch 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 DakotaResearch Site, Fargo (Not yet recruiting)
Research Site, Grand Forks (Not yet recruiting)
OhioResearch Site, Columbus (Not yet recruiting)
Research Site, Dayton (Not yet recruiting)
Research Site, Maumee (Not yet recruiting)
OklahomaResearch Site, Oklahoma City (Not yet recruiting)
PennsylvaniaResearch 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 IslandResearch Site, East Providence (Not yet recruiting)
South CarolinaResearch Site, Spartanburg (Not yet recruiting)
South DakotaResearch Site, Rapid City (Not yet recruiting)
TexasResearch 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)
VirginiaResearch Site, Arlington (Not yet recruiting)
WashingtonResearch Site, Redmond
West VirginiaResearch 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.