Elecoglipron vs placebo for adults with HFpEF or HFmrEF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind study comparing elecoglipron to placebo in adults with HFpEF or HFmrEF. Participants will be on background dapagliflozin and other standard heart failure care. The study will measure cardiovascular outcomes over time across multiple centers. Key eligibility includes preserved or mildly reduced ejection fraction and NYHA class II–IV, with several medical exclusions in place. The trial is sponsored by AstraZeneca and will take place at three sites in the United States.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Fairhope, Alabama, United States Recruiting
• Research Site
  Lomita, California, United States Recruiting
• Research Site
  Miami Lakes, Florida, United States Recruiting
• Research Site
  Flint, Michigan, United States Recruiting
• Research Site
  Brooklyn, New York, United States Recruiting
• Research Site
  The Bronx, New York, United States Recruiting

+629 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Coronary stents for people with HFpEF and blocked heart arteries

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.