Recruiting
Phase 3

Elecoglipron

Sponsor:

AstraZeneca

Code:

NCT07761117

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elecoglipron

Placebo

Study Details

Brief 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.

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)

Study ID

NCT07761117

Start date

Aug 24, 2026

Status verified date

Aug, 2026

Completion date

Sep 3, 2029

Anticipated

Primary completion date

Sep 3, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

6950 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Elecoglipron

Elecoglipron tablet once daily

active comparator: Placebo

Placebo matching Elecoglipron tablet once daily

Interventions

Elecoglipron

Elecoglipron tablet

Placebo

Placebo tablet

Primary outcome measure

  • To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit [ Time Frame: Up to 42 months ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Fairhope, Alabama, United States, 36532

Research Site

Recruiting

Lomita, California, United States, 90717

Research Site

Recruiting

Miami Lakes, Florida, United States, 33016

Research Site

Recruiting

Flint, Michigan, United States, 48503

Research Site

Recruiting

Brooklyn, New York, United States, 11220

Research Site

Recruiting

The Bronx, New York, United States, 10455

Research Site

Recruiting

Humble, Texas, United States, 77338

Research Site

Recruiting

Tomball, Texas, United States, 77375

Research Site

Recruiting

Redmond, Washington, United States, 98052

Research Site

Recruiting

Kingston, Ontario, Canada, K7M 7E4

Research Site

Recruiting

Newmarket, Ontario, Canada, L3Y 2P6

Research Site

Recruiting

North York, Ontario, Canada, M6B 3H7

Research Site

Recruiting

Oakville, Ontario, Canada, L6K 3W7

Research Site

Recruiting

Stoney Creek, Ontario, Canada, L8J 3W2

More Information

Sponsor

AstraZeneca

Last update posted

Sep 28, 2026

Last verified

Aug, 2026

Keywords

  • Heart failure
  • Elecoglipron

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.