RightFit
RecruitingPhase 3

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

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants With HFpEF and HFmrEF (Elevate-HF)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether elecoglipron affects heart-related outcomes compared with a placebo (a treatment with no active drug). It is for adults with heart failure whose heart pumps a normal or mildly reduced share of blood, with or without type 2 diabetes. Participants take dapagliflozin along with their other usual care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A heart test in the past 12 months showed that the main pumping chamber pushed out more than 40% of its blood with each beat.
  • Tests show changes in the heart’s structure.
  • Heart failure is rated NYHA class II–IV at screening, meaning symptoms occur with activity or at rest.

Who can't join

  • Body mass index (BMI), a measure based on height and weight, is below 25 at screening.
  • Type 1 diabetes, or an HbA1c of 10% or higher at screening. HbA1c measures average blood sugar.
  • Current or expected treatment for diabetes-related eye damage or swelling; more than one severe low blood sugar event in the past 180 days; or trouble noticing low blood sugar.
  • Use of a kidney replacement treatment ruled out by the study, or kidney function below the study’s set limit.
  • Certain heart procedures in the past 90 days or planned after study assignment: major heart surgery, procedures to restore heart blood flow, valve repair or replacement, treatment for abnormal heart rhythms, or placement of certain heart pacing or shock devices.
  • Heart failure caused by certain diseases: material buildup in heart muscle, active heart muscle swelling, a stiff or fluid-filled sac around the heart, inherited thick heart muscle, or a disease that damages the right heart chamber and causes abnormal rhythms.
  • A major upper digestive tract condition affecting stomach emptying, drug absorption, or safety checks; long-term use of drugs that change digestive movement; severe digestive disease or past surgery; or past sudden or long-term swelling of the pancreas.
  • Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (a condition that causes tumors in hormone-making glands), or a calcitonin blood level of 35 ng/L or higher at screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (120)

AK

AL

AZ

CA

CO

CT

FL

GA

IA

IL

IN

KS

KY

LA

MA

MD

MI

MO

NC

ND

NE

NJ

NY

OH

OK

PA

RI

SC

SD

TX

VA

VT

WA

WV