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

Recruiting · NCT07761117 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 34 US states.

Research Site - Fairhope, Alabama, United States
Research Site - Anchorage, Alaska, United States
Research Site - Gilbert, Arizona, United States
Research Site - Surprise, Arizona, United States
Research Site - Beverly Hills, California, United States
Research Site - Huntington Beach, California, United States
Research Site - Huntington Park, California, United States
Research Site - Loma Linda, California, United States
Research Site - Lomita, California, United States
Research Site - Mather, California, United States
Research Site - Northridge, California, United States
Research Site - Palo Alto, California, United States
Research Site - Redding, California, United States
Research Site - San Diego, California, United States
Research Site - Tarzana, California, United States
Research Site - Colorado Springs, Colorado, United States
Research Site - New Haven, Connecticut, United States
Research Site - Bradenton, Florida, United States
Research Site - Hallandale, Florida, United States
Research Site - Jacksonville, Florida, United States
Research Site - Lakeland, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Miami Lakes, Florida, United States
Research Site - Miami Lakes, Florida, United States
Research Site - Ocoee, Florida, United States
Research Site - Palmetto Bay, Florida, United States
Research Site - Riverview, Florida, United States
Research Site - Atlanta, Georgia, United States
Research Site - Columbus, Georgia, United States
Research Site - Tucker, Georgia, United States
Research Site - Champaign, Illinois, United States
Research Site - Chicago, Illinois, United States
Research Site - Gurnee, Illinois, United States
Research Site - Melrose Park, Illinois, United States
Research Site - Moline, Illinois, United States
Research Site - Niles, Illinois, United States
Research Site - Rockford, Illinois, United States
Research Site - Schaumburg, Illinois, United States
Research Site - Winfield, Illinois, United States
Research Site - Indianapolis, Indiana, United States
Research Site - Waterloo, Iowa, United States
Research Site - Leavenworth, Kansas, United States
Research Site - Wichita, Kansas, United States
Research Site - Owensboro, Kentucky, United States
Research Site - Bossier City, Louisiana, United States
Research Site - Covington, Louisiana, United States
Research Site - Lafayette, Louisiana, United States
Research Site - New Orleans, Louisiana, United States
Research Site - Shreveport, Louisiana, United States
Research Site - Zachary, Louisiana, United States
Research Site - Annapolis, Maryland, United States
Research Site - Baltimore, Maryland, United States
Research Site - Lanham, Maryland, United States
Research Site - Oxon Hill, Maryland, United States
Research Site - Boston, Massachusetts, United States
Research Site - Boston, Massachusetts, United States
Research Site - New Bedford, Massachusetts, United States
Research Site - Worcester, Massachusetts, United States

Showing 60 of 672 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →