New heart failure drug enters first human safety trial
NCT ID NCT07547540
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 5 times
Summary
This early-stage trial will test a single dose of a new drug called LY3971297 in 90 people with two types of heart failure: preserved ejection fraction (HFpEF) and reduced ejection fraction (HFrEF). The main goal is to see if the drug is safe and what side effects occur. Participants will be monitored for about two months, including a 4-day hospital stay and 5 follow-up visits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LY3971297
- What this could lead to
- If safe, this could pave the way for larger studies testing whether LY3971297 helps control heart failure symptoms.
- What could go wrong
- This is an early Phase 1 safety trial with only a single dose, so it is not designed to prove effectiveness. Side effects are unknown and the drug may not work in later trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ARENSIA Research Clinic at County Clinical Hospital, Cluj-Napoca
NOT_YET_RECRUITINGCluj-Napoca, 400347, Romania
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Henry Ford Health System
NOT_YET_RECRUITINGDetroit, Michigan, 48202, United States
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Houston Methodist Hospital
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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Institut de Cardiologie
NOT_YET_RECRUITINGChisina, 2005, Moldova
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Kobe University Hospital
NOT_YET_RECRUITINGKobe, 650-0017, Japan
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Kyoto University Hospital
NOT_YET_RECRUITINGKyoto, 606-8507, Japan
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National Cerebral and Cardiovascular Center
NOT_YET_RECRUITINGSuita-shi, 564-8565, Japan
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National Hospital Organization Kasumigaura Medical Center
NOT_YET_RECRUITINGTsuchiura-shi, 300-8585, Japan
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Republican Clinical Hospital ARENSIA Exploratory Medicine
RECRUITINGChisinau, 2025, Moldova
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University Medical Center Groningen
NOT_YET_RECRUITINGGroningen, 9713 GZ, Netherlands
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University of North Carolina, Division of Cardiology
NOT_YET_RECRUITINGChapel Hill, North Carolina, 27599, United States
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Washington University
NOT_YET_RECRUITINGSt Louis, Missouri, 63110, United States
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