NCT06148272
A Study of LY3971297 in Healthy Participants
Active, Not Recruiting
PHASE1Ages 18–75InterventionalBasic scienceEli Lilly and Company
~225 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:LY3971297PlaceboLY3971297 IV
At a glance
Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Baseline (Day of Exposure) to Day 29 post-dose
+3 more outcomes measured
Conditions
Where it's being run
7 sites across 5 statesJapan3
California1
Florida1
Texas1
Singapore1
Study leadership
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
For Parts A, B, C, E, and F: Overtly healthy males or females as determined by medical history and physical examination
For Parts A, B, C, E, and F: Have a screening body mass index (BMI) in the range of 18.5 to 35 kilogram per square meter (kg/m²), inclusive, with no significant weight gain or loss in the past 3 months prior to screening
For Part C, to qualify as Chinese for the purpose of this study, all the participants' biological grandparents must be of exclusive Chinese descent and born in China
For Part D, participants must have a stable dose of medications within the past 3 months prior to screening
For Part D, obesity BMI in the range of 30 to 40 kg/m², inclusive, with a waist circumference of at least 102 centimeter (cm) for men and at least 89 cm for women for participants of US sites only. For participants of Singaporean, South Asian, Japanese, and/or Chinese Origin at sites outside the US, the BMI range is 27 to 40 kg/m2 and the waist circumference is at least 90 cm for men and at least 80 cm for women
For Part E, to qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participants' biological grandparents must be of exclusive Japanese descent and born in Japan
Male participants must agree to adhere to contraception restrictions and female participants must be women not of childbearing potential
For Part G, have a screening BMI in the range of 18.5 to 40 kg/m², inclusive, with no significant weight gain or loss in the past 3 months prior to screening
For Part G, participants have a decreased estimated glomerular filtration rate (eGFR)
For Parts D and G, participants are allowed to have stable background treatment for hypertension, type 2 diabetes mellitus (on oral drug therapy and/or long-acting insulin), dyslipidemia (on statin therapy) and/or hypothyroidism as determined by the investigator
For Part G, Participants should be on a stable dose of angiotensin converting enzyme inhibitor or angiotensin II receptor blocker
Exclusion
Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
Have known or ongoing psychiatric disorders that, in the opinion of the investigator, increases the risks associated with study participation
Have blood pressure and/or pulse rate constituting a risk as determined by the investigator
Have a systolic blood pressure (BP) of less than 100 millimeters of mercury (mmHg)
Diagnosed with orthostatic hypotension defined as a decrease in systolic blood pressure of equal to or greater than 20 mmHg or a decrease in diastolic blood pressure of equal to or greater than 10 mmHg when compared with BP from the supine position
For US sites: have donated blood of more than 500 mL within the previous 3 months of screening or intend to donate blood during the course of the study
For Singapore sites: Have donated blood of more than 450 mL or more in the past 3 months or provided any blood donation within the past 1 month before screening
Consume more than 10 cigarettes per day (or the equivalent) or are unable or unwilling to abstain from nicotine
Have alcohol intake that exceeds recommended alcohol consumption limits per local regulation or are unwilling to stop alcohol consumption 24 hours prior to dosing until discharge
For Part D, has concurrent use or anticipated use of phosphodiesterase 5 inhibitor such as vardenafil, tadalafil, and sildenafil, soluble guanylyl cyclase activators (such as riociguat and vericiguat)
For Parts D and G, has concurrent or anticipated use of long-acting nitrates or nitric oxide (NO) donors
For Part D, has current use of more than 3 mechanism of actions for treatment of hypertension
For Part G, has previous or current diagnosis of primary glomerulopathy, vasculitic renal disease, prior dialysis or unstable rapidly progressing renal disease, autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis, or anti-neutrophil cytoplasm antibody-associated vasculitis
What this trial measures
- 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 AdministrationBaseline (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 AdministrationBaseline (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 LY3971297Baseline Up to Day 29 post-dose for Part F
Part F: PK: AUC of LY3971297
- Part F: PK: Maximum Observed Drug Concentration (Cmax) of LY3971297Baseline Up to Day 29 post-dose for Part F
Part F: PK: Cmax of LY3971297