Actively Recruiting
A Study of LY3971297 in Healthy Participants
Led by Eli Lilly and Company · Updated on 2026-04-20
225
Participants Needed
7
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to measure side effects of LY3971297 injection administered under the skin in healthy participants and obese participants with high blood pressure (BP). Blood tests will be performed to check how much LY3971297 gets into the bloodstream and how long it takes the body to eliminate it. This is a 7-part study. The study duration will be approximately 60 days for Parts A and F, and approximately 90 days for Parts B, C, D, E, and G.
CONDITIONS
Official Title
A Study of LY3971297 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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: Screening BMI between 18.5 and 35 kg/m2 with no significant weight change in past 3 months
- For Part C: Participants must have biological grandparents of exclusive Chinese descent born in China
- For Part D: Stable medication dose for past 3 months
- For Part D: Obesity BMI between 30 and 40 kg/m2 with waist circumference at least 102 cm for men and 89 cm for women at US sites; BMI 27 to 40 kg/m2 and waist circumference at least 90 cm for men and 80 cm for women at certain non-US sites
- For Part E: Participants and their biological parents and grandparents must be of exclusive Japanese descent born in Japan
- Male participants must agree to contraception restrictions; female participants must be women not of childbearing potential
- For Part G: Screening BMI between 18.5 and 40 kg/m2 with no significant weight change in past 3 months
- For Part G: Participants must have decreased estimated glomerular filtration rate (eGFR)
- For Parts D and G: Allowed stable treatments for hypertension, type 2 diabetes (oral or long-acting insulin), dyslipidemia (statins), and/or hypothyroidism
- For Part G: Must be on stable dose of ACE inhibitor or angiotensin II receptor blocker
You will not qualify if you...
- History or current cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, or neurological disorders
- Known or ongoing psychiatric disorders increasing study risks
- Blood pressure or pulse rate posing risk as determined by investigator
- Systolic blood pressure below 100 mmHg
- Diagnosed orthostatic hypotension as defined by blood pressure drop criteria
- Blood donation exceeding limits in past 3 months or planned during study (varies by site)
- Smoking more than 10 cigarettes per day or unwillingness to abstain from nicotine
- Alcohol intake exceeding local recommended limits or unwillingness to stop alcohol 24 hours before dosing until discharge
- For Part D: Use or planned use of phosphodiesterase 5 inhibitors or soluble guanylyl cyclase activators
- For Parts D and G: Use or planned use of long-acting nitrates or nitric oxide donors
- For Part D: Use of more than 3 mechanisms of action for hypertension treatment
- For Part G: Prior or current diagnosis of specific kidney diseases including primary glomerulopathy, vasculitis, dialysis, rapidly progressing renal disease, polycystic kidney disease, lupus nephritis, or certain vasculitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
CenExel ACT
Anaheim, California, United States, 92801
Actively Recruiting
2
Clinical Pharmacology of Miami
Miami, Florida, United States, 33172
Actively Recruiting
3
ICON Early Phase Services
San Antonio, Texas, United States, 78209
Actively Recruiting
4
Hakata Clinic
Fukuoka, Japan, 812-0025
Active, Not Recruiting
5
P-One Clinic
Hachiōji, Japan, 192-0071
Active, Not Recruiting
6
Clinical Research Hospital Tokyo
Shinjuku-ku, Japan, 160-0004
Active, Not Recruiting
7
Lilly Centre for Clinical Pharmacology
Singapore, Singapore, 138623
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
8
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