A Study of LY3971297 in Participants With Heart Failure (NCT07547540) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
United States, Japan, Moldova90 participantsStarted 2026-07
Plain-language 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). 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Are between 30 days and within 12 months from recent heart failure hospitalization to 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 \>…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial studying LY3971297, meaning it's primarily focused on safety rather than proving the drug works, what does that mean for my personal risk if I were to consider enrolling?
2The trial isn't recruiting yet — given where I am in my diagnosis and treatment right now, is there a realistic chance I'd even be a candidate by the time it opens, and should I be pursuing other options in the meantime?
3The main things being measured are serious adverse events and treatment-related side effects, not whether the drug actually improves heart function — so how would participating benefit me directly, if at all, compared to sticking with my current heart failure treatment?
4My heart failure involves both the pumping and filling functions of my heart — do you think this trial is specifically relevant to my type of heart failure, or is it enrolling a broad group where the drug might not be tailored to my situation?
5If I were to eventually discuss enrolling in this study, what would my monitoring schedule look like, and would the extra visits and safety checks be manageable given my current health and daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Timeframe: Baseline through Study Completion (Approximately 2 Months)
2
Number of Participants with One or More Treatment-Emergent Adverse Event
Timeframe: Baseline through Study Completion (Approximately 2 Months)
Trial details
NCT IDNCT07547540
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-11
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or