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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6,950
Elecoglipron tablet
Placebo tablet
Research Site
Fairhope, Alabama, United States
RECRUITINGResearch Site
Anchorage, Alaska, United States
NOT_YET_RECRUITINGResearch Site
Gilbert, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Surprise, Arizona, United States
NOT_YET_RECRUITINGTo evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit
Time to first event of the composite of: * CV death * HHF * Urgent HF visit
Time frame: Up to 42 months
To evaluate the effect of elecoglipron compared with placebo in reducing the rate of HF events (HHF or urgent HF visit)
Total occurrences (first and recurrent) of: * HF events * HHF * Urgent HF visit
Time frame: Up to 42 months
To evaluate the effect of elecoglipron compared to placebo on improving patient-reported outcomes using a questionnaire.
Change from baseline to Week 52
Time frame: Baseline and 52 weeks
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 to first event of the composite of: * All-cause death * HHF * MI * Stroke
Time frame: Up to 42 months
AstraZeneca Clinical Study Information Center
CONTACT
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Research Site
Beverly Hills, California, United States
NOT_YET_RECRUITINGResearch Site
Huntington Beach, California, United States
NOT_YET_RECRUITINGResearch Site
Huntington Park, California, United States
NOT_YET_RECRUITINGResearch Site
Loma Linda, California, United States
NOT_YET_RECRUITINGResearch Site
Lomita, California, United States
NOT_YET_RECRUITINGResearch Site
Mather, California, United States
NOT_YET_RECRUITING...and 662 more locations