Back to search results

A Study of LY3971297 for Heart Failure

This study is testing a new drug called LY3971297 in people with heart failure. The main goal is to see if LY3971297 is safe and what side effects it might cause in people with different types of heart failure (HFpEF and HFrEF). Researchers will also take blood samples to understand how your body handles the drug and how the drug affects your body. You might receive LY3971297 or a placebo (an inactive substance). To join, you need to be 18 to 65 years old, have chronic heart failure (NYHA Class II-III), and be on stable heart failure medication for at least 6 months. The study aims to enroll 90 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 90 participants, but the phase of the study is not specified.
What's involved
Your participation would last about 2 months, including one 4-day stay in the hospital and 5 outpatient visits.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects from the start of the study through its completion, which is approximately 2 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07547540

A Study of LY3971297 in Participants With Heart Failure

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Eli Lilly and Company
~90 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:LY3971297Placebo

At a glance

Recruiting sites
1 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Measured over Baseline through Study Completion (Approximately 2 Months)
+1 more outcome measured

Conditions

Heart Failure
Heart Failure, Diastolic
Heart Failure, Systolic

Explore related trials

Heart FailureN-Terminal Fragment Brain Natriuretic Protein

NCT07547540

Where you'd take part

This study runs at 12 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • ARENSIA Research Clinic at County Clinical Hospital, Cluj-Napoca

    Cluj-Napoca, Romaniastudy coordinator listed

    Not yet recruiting

  • Henry Ford Health System

    Detroit, Michiganstudy coordinator listed

    Not yet recruiting

  • Kobe University Hospital

    Kobe, Japanstudy coordinator listed

    Not yet recruiting

  • Kyoto University Hospital

    Kyoto, Japanstudy coordinator listed

    Not yet recruiting

  • National Cerebral and Cardiovascular Center

    Suita-shi, Japanstudy coordinator listed

    Not yet recruiting

  • National Hospital Organization Kasumigaura Medical Center

    Tsuchiura-shi, Japanstudy coordinator listed

    Not yet recruiting

  • Republican Clinical Hospital ARENSIA Exploratory Medicine

    Chisinau, Moldovastudy coordinator listed

    Recruiting

  • University Medical Center Groningen

    Groningen, Netherlandsstudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Are diagnosed with chronic heart failure with New York Heart Association Class II-III (Heart Failure) HF symptomatology at screening and on guideline-directed HF therapy for at least 6 months prior to screening.
Have not changed optimal guideline-directed HF therapy, either medication or medication dose, in the last 4 weeks prior to screening and during screening period, and do not plan to change HF therapy for the next 90 days.
Must be on a stable dose of vasodilator therapy for at least 4 weeks prior to screening, with no dose adjustments planned during the study.
Have an estimated glomerular filtration rate of greater than or equal to (≥) 30 milliliter per minute per 1.73 square meters (mL/Minute/1.73m²) at screening.
Have systolic blood pressure (SBP) greater than (\>) 110 millimeters of mercury (mmHg) at screening and at enrollment.
Have a body mass index within the range of 18.5 to 40 kilograms per square meter (kg/m²) (inclusive).
Are individuals assigned male or female at birth, who are not of childbearing potential.
Have venous access sufficient to allow blood sampling.
Applicable to heart failure with preserved ejection fraction (HFpEF) participants only
Have left ventricular ejection fraction (LVEF) \>45 percent (%).
Left atrial volume index \>34 milliliters per square meter (mL/m²) in participants in sinus rhythm, or \>40 mL/m² in participants with atrial fibrillation (AF).
N-terminal pro-B-type natriuretic peptide (NT-proBNP) \>300 picograms per milliliter (pg/mL) for participants without AF or \>850 pg/mL for participants with AF.
Have a documented history of signs, symptoms, or both, consistent with HFpEF.
Applicable to heart failure with reduced ejection fraction (HFrEF) participants only:
Have LVEF \<40% .
NT-proBNP \>600 pg/mL for participants without AF or \>900 pg/mL for participants with AF.
Have a documented history of signs, symptoms, or both, consistent with HFrEF.

Exclusion

Have known allergies to related compounds of LY3971297 or any components of the formulation, or a history of significant atopy.
Had a myocardial infarction, unstable angina pectoris, coronary artery bypass graft surgery, revascularization or other major cardiovascular surgery, stroke, or transient ischemic attack in the last 90 days prior to screening.
Have New York Heart Association (NYHA) Class 4, acute decompensated HF (exacerbation of HF) requiring IV diuretics, IV inotropes, or IV vasodilators, within 30 days prior to screening, and/or during screening period until randomization.
Have SBP ≥180 mmHg at screening.
Have symptomatic hypotension.
Have resting heart rate \>90 beats per minute (bpm) at screening.
Have known cardiac amyloidosis, infiltrative myocardial diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic cardiomyopathy, pericardial constriction, or complex congenital heart disease.
Have any history of moderate-to-severe stenosis of the mitral and/or aortic valve or severe mitral and/or aortic regurgitation.
Have any history of moderate-to-severe tricuspid or pulmonic valve stenosis or severe tricuspid or pulmonic regurgitation.
Have a history of syncope that, in the opinion of the investigator, may affect the participant's safety.
Bioprosthetic valve replacement within 12 months prior to screening or any history of mechanical valve replacement, or planned valve replacement or repair during the study period.
Have any history of greater than moderate pulmonary hypertension.
Have a pacemaker or implantable cardioverter-defibrillator placement within 90 days prior to screening.
Have severe chronic obstructive pulmonary disease (COPD).
Have clinically significant or uncontrolled cardiac arrhythmia.
Have a significant history of, or presence of, hepatic disease, including any abnormal liver function tests.
Have, within 3 years prior to screening, a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (Exceptions: basal or squamous cell skin cancer).
For US sites: have donated blood of more than 500 mL within the previous 90 days of screening or intend to donate blood during the course of the study.
For Japan sites: have donated any blood within the last 4 weeks, any apheresis (blood components) within the last 2 weeks, at least 400 mL of blood within the last 16 weeks for female participants or 12 weeks for male participants, or at least 800 mL of blood for female participants or 1200 mL of blood for male participants within 12 months.
Other sites: Participants who have recently donated blood or blood components, or who intend to donate during the course of the study.
Have not been on a stable dose of medications for at least 4 weeks prior to screening, or have planned dose adjustments during the study.
Participants must abstain from taking new prescription or nonprescription drugs.
Have concurrent use or intend to use phosphodiesterase 5 inhibitor or soluble guanylyl cyclase activators.
Have any history of intolerance to vasodilator medications that, in the opinion of the investigator, would put them at risk of not tolerating study drug.
Have BP and/or pulse rate constituting a risk when taking the Investigational Medicinal Product (IMP).
Are diagnosed with orthostatic hypotension.
Show evidence of an acute infection with fever or infectious disease at screening.
Applicable to HFrEF participants only
Have been listed for cardiac transplantation and/or anticipated or implanted ventricular assist device.
Have received cardiac resynchronization therapy for less than 6 months.
Hospitalization for heart failure within 30 days of screening.

What this trial measures

  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug AdministrationBaseline through Study Completion (Approximately 2 Months)
  • Number of Participants with One or More Treatment-Emergent Adverse EventBaseline through Study Completion (Approximately 2 Months)