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Heart FailurePhase 1NCT07547540

A Study of LY3971297 in Participants With Heart Failure

A Phase 1 study testing LY3971297 in people with Heart Failure and Heart Failure, Diastolic, run by Eli Lilly and Company at 12 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The main purpose of this study is to assess how well LY3971297 is tolerated and what side effects may occur in participants with heart failure with preserved ejection fraction (HFpEF) and participants with heart failure with reduced ejection fraction (HFrEF). Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
LY3971297
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
12 sitesin 5 countries
Study dates
11 Aug 2026to Nov 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

12 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

12 sites in 5 countries

United States4 sites, 4 recruiting

  • University of North Carolina, Division of Cardiology

    Chapel Hill, North Carolina, 27599

    919-843-9937

    Kirkwood Adams

    Not yet recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    313-916-6375

    David Lanfear

    Not yet recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Mahwash Kassi

    Not yet recruiting

  • Washington University

    St Louis, Missouri, 63110

    314-454-7009

    Gregory Ewald

    Not yet recruiting

Other trials in United States

Japan4 sites, 4 recruiting

  • Kobe University Hospital

    Kobe, 650-0017

    81120023812

    Hiromasa Otake

    Not yet recruiting

  • Kyoto University Hospital

    Kyoto, 606-8507

    81120023812

    Koh Ono

    Not yet recruiting

  • National Cerebral and Cardiovascular Center

    Suita-shi, 564-8565

    81120023812

    Takeshi Kitai

    Not yet recruiting

  • National Hospital Organization Kasumigaura Medical Center

    Tsuchiura-shi, 300-8585

    81120023812

    Hidekazu Maruyama

    Not yet recruiting

Other trials in Japan

Moldova2 sites, 2 recruiting

  • Institut de Cardiologie

    Chisina, 2005

    Valeriu Revenco

    Not yet recruiting

  • Republican Clinical Hospital ARENSIA Exploratory Medicine

    Chisinau, 2025

    373 79 383361

    Vasile Corcea

    Recruiting

Other trials in Moldova

Netherlands1 site, 1 recruiting

  • University Medical Center Groningen

    Groningen, 9713 GZ

    31 (0) 50-361-42-00

    Kevin Damman

    Not yet recruiting

Other trials in Netherlands

Romania1 site, 1 recruiting

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

    Cluj-Napoca, 400347

    40765258870

    Mihaela Mocan

    Not yet recruiting

Other trials in Romania

About this study

Official title: A Phase 1, Single-Blinded, Single-Ascending Dose Study to Evaluate the Safety and Tolerability of a Single Dose of LY3971297 in Participants With HFpEF and Participants With HFrEF

The main purpose of this study is to assess how well LY3971297 is tolerated and what side effects may occur in participants with heart failure with preserved ejection fraction (HFpEF) and participants with heart failure with reduced ejection fraction (HFrEF). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 2 months and will include 1 inpatient visit lasting approximately 4 days and 5 outpatient visits.

Being tested
LY3971297, Placebo
Medical subject headings
Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3971297Drug

    Administered SC

  • LY3971297Drug

    Administered IV

  • PlaceboDrug

    Administered SC

  • PlaceboDrug

    Administered IV

Study groups in NCT07547540
Study groupRoleWhat they receive
LY3971297 Part A Cohort 1ExperimentalLY3971297 administered subcutaneously (SC)
Receives: Drug: LY3971297
Placebo Part A Cohort 1Placebo comparatorPlacebo administered SC
Receives: Drug: Placebo
LY3971297 Part A Cohort 2ExperimentalLY3971297 administered SC
Receives: Drug: LY3971297
Placebo Part A Cohort 2Placebo comparatorPlacebo administered SC
Receives: Drug: Placebo
LY3971297 Part A Cohort 3ExperimentalLY3971297 administered SC
Receives: Drug: LY3971297
Placebo Part A Cohort 3Placebo comparatorPlacebo administered SC
Receives: Drug: Placebo
LY3971297 Part A Cohort 4ExperimentalLY3971297 administered SC
Receives: Drug: LY3971297
Placebo Part A Cohort 4Placebo comparatorPlacebo administered SC
Receives: Drug: Placebo
LY3971297 Part A Cohort 5ExperimentalLY3971297 administered intravenously (IV)
Receives: Drug: LY3971297
Placebo Part A Cohort 5Placebo comparatorPlacebo administered IV
Receives: Drug: Placebo
LY3971297 Part BExperimentalLY3971297 administered SC or IV
Receives: Drug: LY3971297
Placebo Part BPlacebo comparatorPlacebo administered SC or IV
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Measured: Baseline through Study Completion (Approximately 2 Months)

  2. Number of Participants with One or More Treatment-Emergent Adverse Event

    Measured: Baseline through Study Completion (Approximately 2 Months)

Secondary outcomes (2)

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3971297

    Measured: Predose on Day 1 up to Day 29 Post-Dose

  2. PK: Maximum Concentration (Cmax) of LY3971297

    Measured: Predose on Day 1 up to Day 29 Post-Dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start11 Aug 2026
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07547540
Sponsor's protocol ID
27777
Other IDs
J4O-MC-EZHB, 2026-525663-40-00
Status last verified
Nov 2026
First submitted
17 Apr 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3971297 in people with Heart Failure and Heart Failure, Diastolic, run by Eli Lilly and Company at 12 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Japan, Moldova, Netherlands, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Study Completion (Approximately 2 Months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07547540.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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