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.
• 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.