A Study of LY3971297 in Participants With Heart Failure
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEli Lilly and Company
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
LY3971297
DrugAdministered SC
LY3971297
DrugAdministered IV
Placebo
DrugAdministered SC
Placebo
DrugAdministered IV
Treatment groups
90 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Group A: LY3971297 Part A Cohort 1Experimental treatment 1 intervention
Group B: Placebo Part A Cohort 1Placebo comparator 1 intervention
Group C: LY3971297 Part A Cohort 2Experimental treatment 1 intervention
Group D: Placebo Part A Cohort 2Placebo comparator 1 intervention
Group E: LY3971297 Part A Cohort 3Experimental treatment 1 intervention
Group F: Placebo Part A Cohort 3Placebo comparator 1 intervention
Group G: LY3971297 Part A Cohort 4Experimental treatment 1 intervention
Group H: Placebo Part A Cohort 4Placebo comparator 1 intervention
Group I: LY3971297 Part A Cohort 5Experimental treatment 1 intervention
Group J: Placebo Part A Cohort 5Placebo comparator 1 intervention
Group K: LY3971297 Part BExperimental treatment 1 intervention
Group L: Placebo Part BPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
Number of Participants with One or More Treatment-Emergent Adverse Event
Time frame
Baseline through Study Completion (Approximately 2 Months)Secondary outcomes
1
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3971297
Time frame
Predose on Day 1 up to Day 29 Post-Dose2
PK: Maximum Concentration (Cmax) of LY3971297
Time frame
Predose on Day 1 up to Day 29 Post-DoseSponsors and contacts
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Source ClinicalTrials.gov