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

Summary

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

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.

Conditions3

Interventions1

Locations118 sites

Find trials near these locations

Related trials

• A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus — AstraZeneca
• A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM — AstraZeneca
• A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus — AstraZeneca
• A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus — AstraZeneca
• A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus — AstraZeneca
• A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin — AstraZeneca
• A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin — AstraZeneca

Browse More Trials