Trial comparing treatments for Heart Failure With Preserved Ejection Fraction (HFpEF)
Official title A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF
ClinicalTrials.gov ID: NCT07761117
What this study is testing
What is Elecoglipron?
Elecoglipron is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for heart failure with preserved ejection fraction (hfpef).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if elecoglipron changes heart-related outcomes compared with placebo in people with HFpEF or HFmrEF.
- Who it's for
- Adults who have HFpEF or HFmrEF, are already taking dapagliflozin and standard heart‑failure medicines, regardless of diabetes status.
- What's involved
- Participants will be randomly given either elecoglipron or a placebo while continuing their usual heart‑failure treatment, and will have scheduled clinic visits and tests.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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...
- GI exclusions:
- Clinically significant upper GI condition affecting gastric emptying, drug absorption, or safety/side effects 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.
The study team makes the final eligibility decision.
Where it's taking place
- 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
+ 508 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 522 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.