NCT07761117 · AstraZeneca
A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF
(Elevate-HF)
What this study is about
This is a Phase III, randomly assigned, where neither patients nor doctors know which treatment is given, parallel-group, compared against an inactive treatment, conducted at multiple hospitals 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 the usual treatment.
View original scientific description
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
DRUG
Elecoglipron
Elecoglipron tablet
DRUG
Placebo
Placebo tablet
Primary outcome measures
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
Time to first event of the composite of: * CV death * HHF * Urgent HF visit
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Fairhope, Alabama
- Anchorage, Alaska
- Gilbert, Arizona
- Surprise, Arizona
- Beverly Hills, California
- Huntington Beach, California
- Huntington Park, California
- Loma Linda, California
- Lomita, California
- Mather, California
- Northridge, California
- Palo Alto, California
And 94 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2026 · Source of record for eligibility and locations