Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
225 participants
INTERVENTIONAL
2023-12-07
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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LY3971297 (Part A)
Single ascending doses of LY3971297 administered subcutaneously (SC) in healthy participants
LY3971297
Administered SC
LY3971297 (Part B)
Multiple ascending doses of LY3971297 administered SC in healthy participants
LY3971297
Administered SC
LY3971297 (Part C)
Multiple ascending doses of LY3971297 administered SC in healthy Chinese participants
LY3971297
Administered SC
LY3971297 (Part D)
Multiple ascending doses of LY3971297 administered SC
LY3971297
Administered SC
LY3971297 (Part E)
Multiple doses of LY3971297 administered SC in healthy Japanese participants
LY3971297
Administered SC
Placebo (Part A, B, C, D, E, & G)
Placebo administered SC
Placebo
Administered SC
LY3971297 (Part F)
Single doses of LY3971297 administered intravenously (IV) in healthy participants
LY3971297 IV
Administered IV
LY3971297 (Part G)
Multiple doses of LY3971297 administered SC
LY3971297
Administered SC
Interventions
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LY3971297
Administered SC
Placebo
Administered SC
LY3971297 IV
Administered IV
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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CenExel ACT
Anaheim, California, United States
ICON Early Phase Services
San Antonio, Texas, United States
Hakata Clinic
Fukuoka, , Japan
P-One Clinic
Hachiōji, , Japan
Clinical Research Hospital Tokyo
Shinjuku-ku, , Japan
Lilly Centre for Clinical Pharmacology
Singapore, , Singapore
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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J4O-MC-EZHA
Identifier Type: OTHER
Identifier Source: secondary_id
18771
Identifier Type: -
Identifier Source: org_study_id