Elevate-HF

RecruitingPhase 3

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)

Lead sponsor

AstraZeneca

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

679

Recruiting sites

Estimated enrollment

6,950

Study population

Heart failure

Eligibility highlights

•EF ≥40%

Primary endpoint

•Effect of elecoglipron

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07761117

Org study IDD7266C00001

Secondary ID2026-526304-79-00

Timeline

Milestones

Study first posted2026-08-12actual

Study start2026-08-24actual

Last update posted2026-09-28actual

Primary completion2029-09-03estimated

Study completion2029-09-03estimated

Assets

Investigational agents

AZD5004 / ECC5004

Who this study enrolls

Heart failure

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Heart failure

Cardiovascular outcomes

Patient-reported / QoL

Cardiovascular outcomes

1 endpoint

Secondary/protocol endpoint

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

Time frame:Up to 42 months

descriptive

Heart failure

2 endpoints

Primary/protocol endpoint

To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit

Time frame:Up to 42 months

descriptive

Secondary/protocol endpoint

To evaluate the effect of elecoglipron compared with placebo in reducing the rate of HF events (HHF or urgent HF visit)

Time frame:Up to 42 months

descriptive

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

To evaluate the effect of elecoglipron compared to placebo on improving patient-reported outcomes using a questionnaire.

Time frame:Baseline and 52 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.