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

NCT07761117

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF), Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)

Interventions: Elecoglipron, Placebo

Countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (672)
  • Fairhope, Alabama, United States
  • Anchorage, Alaska, United States
  • Gilbert, Arizona, United States
  • Surprise, Arizona, United States
  • Beverly Hills, California, United States
  • Huntington Beach, California, United States
  • Huntington Park, California, United States
  • Loma Linda, California, United States
  • Lomita, California, United States
  • Mather, California, United States
  • Northridge, California, United States
  • Palo Alto, California, United States
  • Redding, California, United States
  • San Diego, California, United States
  • Tarzana, California, United States
  • Colorado Springs, Colorado, United States
  • New Haven, Connecticut, United States
  • Bradenton, Florida, United States
  • Hallandale, Florida, United States
  • Jacksonville, Florida, United States
  • Lakeland, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Miami Lakes, Florida, United States
  • Ocoee, Florida, United States
  • Palmetto Bay, Florida, United States
  • Riverview, Florida, United States
  • Atlanta, Georgia, United States
  • + 642 more on CT.gov