A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF
Recruiting
Phase 3Interventional Study
Heart Failure With Preserved Ejection Fraction (HFpEF)Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
6,950 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
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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 backgroun…
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.
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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.
* Diab…
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.
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