RecruitingPhase 1NCT06148272

A Study of LY3971297 in Healthy Participants

A Single-ascending and Multiple-ascending Dose Study of LY3971297 in Healthy Participants and Participants With Obesity and Hypertension and Participants With Decreased Estimated Glomerular Filtration Rate


Sponsor

Eli Lilly and Company

Enrollment

225 participants

Start Date

Dec 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 study testing a new investigational drug called LY3971297 in healthy adult volunteers to assess its safety, tolerability, and how the body processes it. Some parts of the study focus on specific populations, such as people with obesity, kidney impairment, or specific ethnic backgrounds. **You may be eligible if...** - You are a generally healthy adult (for most study parts) - Your BMI is in the normal to overweight range (18.5–35), or the obese range (27–40) for specific parts - You have stable medical conditions (for the part testing people with obesity) - You may qualify for a kidney-impairment group if your kidney function is reduced and you are on stable medications **You may NOT be eligible if...** - You have significant heart, lung, liver, kidney, or neurological disease (for healthy volunteer parts) - You have a known or active psychiatric disorder - You have low blood pressure (systolic below 100 mmHg) or dizziness upon standing - You smoke more than 10 cigarettes per day - You have donated a large amount of blood recently - You drink more than the recommended daily amount of alcohol - For certain parts: you have polycystic kidney disease, lupus nephritis, or are on dialysis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY3971297

Administered SC

DRUGPlacebo

Administered SC

DRUGLY3971297 IV

Administered IV


Locations(7)

CenExel ACT

Anaheim, California, United States

Clinical Pharmacology of Miami

Miami, Florida, 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

View Full Details on ClinicalTrials.gov

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NCT06148272


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