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LY3971297 / Heart Failure, Systolic / Heart Failure · Phase 1 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospective Phase 1 safety and tolerability study of LY3971297 in heart failure (both preserved and reduced ejection fraction phenotypes) that has not yet begun recruitment and has posted no results. The study will generate initial human safety data over approximately 2 months but is not designed to detect clinical efficacy.
Phase 1, Interventional, Randomized, Parallel, Single masking, Treatment purpose. Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic; age from 18 Years; to 65 Years. Intervention: LY3971297 Part A Cohort 1; LY3971297 Part A Cohort 2; LY3971297 Part A Cohort 3; LY3971297 Part A Cohort 4; LY3971297 Part A Cohort 5; LY3971297 Part B. Compared with: Placebo Part A Cohort 1 — Placebo Comparator; Placebo Part A Cohort 2 — Placebo Comparator; Placebo Part A Cohort 3 — Placebo Comparator; Placebo Part A Cohort 4 — Placebo Comparator; Placebo Part A Cohort 5 — Placebo Comparator; Placebo P…. n = 90. 12 sites across 5 countries.
This is a prospective Phase 1 safety and tolerability study of LY3971297 in heart failure (both preserved and reduced ejection fraction phenotypes) that has not yet begun recruitment and has posted no results. The study will generate initial human safety data over approximately 2 months but is not designed to detect clinical efficacy.
No efficacy outcome measures or cardiac function endpoints are specified; this is a safety study only. Pharmacokinetic and pharmacodynamic data collection planned but no results reported.
This Phase 1 trial will establish initial safety and tolerability of a novel molecule in two distinct heart failure phenotypes. Results, when posted, will guide dose escalation and inform the design of later-phase efficacy studies.
Phase 1 safety and tolerability study in heart failure with no posted results; early-stage first-in-patient investigation of a novel mechanism.
As stated by the source record.
Quoted from the source exactly as published.
This Phase 1 trial will establish initial safety and tolerability of a novel molecule in two distinct heart failure phenotypes. Results, when posted, will guide dose escalation and inform the design of later-phase efficacy studies.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07547540). This is a study registration, not published results. Lead sponsor: Eli Lilly and Company. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 90 participants (ESTIMATED). Conditions: Heart Failure, Heart Failure, Diastolic, Heart Failure, Systolic. Interventions: DRUG: LY3971297; DRUG: LY3971297; DRUG: Placebo; DRUG: Placebo. Primary outcome measures: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration , Baseline through Study Completion (Approximately 2 Months); Number of Participants with One or More Treatment-Emergent Adverse Event , Baseline through Study Completion (Approximately 2 Months). Brief 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.
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