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LY3971297

Phase 1

Healthy | Small molecule | Cardiovascular |Eli Lilly and Company|Last Updated: Aug 21, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment225

FDA Designations

No designations recorded

Clinical trial landscape

LY3971297 · 2 trials · 6 indications

Phase 1 2
NCT07547540A Study of LY3971297 in Participants With Heart FailureHeart Failure
RECRUITING90 Analytics
NCT06148272A Study of LY3971297 in Healthy ParticipantsHealthy
ACTIVE NOT_RECRUITING225 Analytics
PHASE1RECRUITING
A Study of LY3971297 in Participants With Heart Failure
Heart FailureUnlock trial analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of LY3971297 in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

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)
Part A and F: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline (Day of Exposure) to Day 29 post-dose

Part A and F: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module

Part B, C, D, E, & G: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline (Day of Exposure) to Day 57 post-dose

Part B, C, D, E, \& G: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module

Part F: Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297
Baseline Up to Day 29 post-dose for Part F

Part F: PK: AUC of LY3971297

Part F: PK: Maximum Observed Drug Concentration (Cmax) of LY3971297
Baseline Up to Day 29 post-dose for Part F

Part F: PK: Cmax of LY3971297

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3971297
Predose on Day 1 up to Day 29 Post-Dose
PK: Maximum Concentration (Cmax) of LY3971297
Predose on Day 1 up to Day 29 Post-Dose
Part B, C, D, E, and G: Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297
Predose on day 1 up to 29 days post-dose for Part A and pre-dose on day 1 up to 57 days post-dose for Part B, C, D, E, and G
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY3971297 Part A Cohort 1EXPERIMENTALLY3971297 administered subcutaneously (SC)
Placebo Part A Cohort 1PLACEBO_COMPARATORPlacebo administered SC
LY3971297 Part A Cohort 2EXPERIMENTALLY3971297 administered SC
Placebo Part A Cohort 2PLACEBO_COMPARATORPlacebo administered SC
LY3971297 Part A Cohort 3EXPERIMENTALLY3971297 administered SC
Placebo Part A Cohort 3PLACEBO_COMPARATORPlacebo administered SC
LY3971297 Part A Cohort 4EXPERIMENTALLY3971297 administered SC
Placebo Part A Cohort 4PLACEBO_COMPARATORPlacebo administered SC
LY3971297 Part A Cohort 5EXPERIMENTALLY3971297 administered intravenously (IV)
Placebo Part A Cohort 5PLACEBO_COMPARATORPlacebo administered IV
LY3971297 Part BEXPERIMENTALLY3971297 administered SC or IV
Placebo Part BPLACEBO_COMPARATORPlacebo administered SC or IV
LY3971297 (Part A)EXPERIMENTALSingle ascending doses of LY3971297 administered subcutaneously (SC) in healthy participants
LY3971297 (Part B)EXPERIMENTALMultiple ascending doses of LY3971297 administered SC in healthy participants
LY3971297 (Part C)EXPERIMENTALMultiple ascending doses of LY3971297 administered SC in healthy Chinese participants
LY3971297 (Part D)EXPERIMENTALMultiple ascending doses of LY3971297 administered SC
LY3971297 (Part E)EXPERIMENTALMultiple doses of LY3971297 administered SC in healthy Japanese participants
Placebo (Part A, B, C, D, E, & G)PLACEBO_COMPARATORPlacebo administered SC
LY3971297 (Part F)EXPERIMENTALSingle doses of LY3971297 administered intravenously (IV) in healthy participants
LY3971297 (Part G)EXPERIMENTALMultiple doses of LY3971297 administered SC

Interventions

NameTypeDescription
LY3971297DRUGAdministered SC
PlaceboDRUGAdministered SC
LY3971297 IVDRUGAdministered IV
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites12

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 ...

Countries:United StatesJapanMoldovaNetherlandsRomaniaSingapore
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Recent Changes (Last 90 Days)

LOWAug 21, 2026NCT07547540Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 21, 2026NCT07547540Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 11, 2026NCT07547540lastUpdatePostDate: changed
LOWAug 11, 2026NCT07547540lastUpdatePostDate: changed
LOWAug 11, 2026NCT07547540lastUpdatePostDate: changed
LOWJul 17, 2026NCT07547540startDate: changed
MEDIUMJul 17, 2026NCT06148272Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJul 17, 2026NCT07547540startDate: changed
MEDIUMJul 17, 2026NCT06148272Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJul 17, 2026NCT07547540startDate: changed
MEDIUMJul 17, 2026NCT06148272Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 16, 2026NCT06148272primaryCompletionDate: changed
MEDIUMJun 16, 2026NCT07547540primaryCompletionDate: changed
LOWJun 16, 2026NCT06148272primaryCompletionDate: changed
MEDIUMJun 16, 2026NCT07547540primaryCompletionDate: changed
LOWJun 16, 2026NCT06148272primaryCompletionDate: changed
MEDIUMJun 16, 2026NCT07547540primaryCompletionDate: changed

Frequently asked questions about LY3971297

What is LY3971297 used for?

LY3971297 is an investigational small molecule being developed by Eli Lilly and Company for the treatment of heart failure, including diastolic and systolic heart failure. It is also being studied in healthy participants with obesity and hypertension to evaluate its safety and tolerability. The drug is currently in Phase 1 clinical development.

What does LY3971297 target?

LY3971297 is a small molecule, but its specific molecular target has not been disclosed in available information. The drug is being studied for its effects in heart failure and related conditions, but the exact mechanism of action is not publicly detailed at this time.

Who makes LY3971297?

LY3971297 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and efficacy in healthy participants and in patients with heart failure.

What phase is LY3971297 in?

LY3971297 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety, tolerability, and potential efficacy in humans.

What clinical trials is LY3971297 in?

LY3971297 is being studied in two Phase 1 clinical trials. The first trial, NCT06148272, is a study in healthy participants with obesity and hypertension, with an enrollment of 225 participants. The second trial, NCT07547540, is a study in participants with heart failure, including diastolic and systolic heart failure, with an enrollment of 90 participants.

Is LY3971297 the same as any other drug?

LY3971297 is a unique investigational drug candidate and no alternative names have been reported for it. It is being developed solely by Eli Lilly and Company under this identifier, and there are no known generic or brand names associated with it at this stage of development.