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Monoclonal Antibodies

LY3971297 for Obesity

Phase 1
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male participants must agree to adhere to contraception restrictions and female participants must be women not of childbearing potential.
Be older than 18 years old
Must not have
For Part D, has concurrent or anticipated use of long-acting nitrates or NO donors.
Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on day 1 up to 29 days post dose for part a and predose on day 1 up to 57 days post dose for part b, c, d, and e
Awards & highlights

Summary

This trial is testing a new drug called LY3971297, which is given as an injection under the skin. The study includes both healthy people and obese people with high blood pressure. Researchers will take blood samples to see how much of the drug enters the bloodstream and how long it stays in the body.

Who is the study for?
This trial is for healthy individuals or those with obesity and high blood pressure. Healthy participants should have a BMI of 18.5 to 35 kg/m2, while obese participants need a BMI of 30 to 40 kg/m2 and meet specific waist measurements. Certain parts require Chinese or Japanese descent. Participants must not have significant health issues, psychiatric disorders, risky blood pressures, recent large blood donations, heavy nicotine or alcohol use, nor take certain medications.
What is being tested?
The study tests LY3971297 injections in different groups: healthy people and those with obesity plus high BP. It checks the drug's safety profile by observing side effects and measures how it's absorbed and cleared from the body over approximately two to three months.
What are the potential side effects?
Specific side effects are not listed but will be monitored throughout the trial as part of its purpose is to measure them when LY3971297 is administered under the skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man who agrees to follow contraception rules or a woman who cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am using or plan to use long-acting nitrates or nitric oxide donors.
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I have a history of or currently have heart, lung, liver, kidney, stomach, hormone, blood, or nerve disorders.
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I have been diagnosed with a significant drop in blood pressure upon standing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 up to 29 days post dose for part a and predose on day 1 up to 57 days post dose for part b, c, d, and e
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1 up to 29 days post dose for part a and predose on day 1 up to 57 days post dose for part b, c, d, and e for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A: 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
Part B, C, D, & E: 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
Secondary study objectives
PK: Maximum Observed Drug Concentration (Cmax) of LY3971297
Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3971297 (Part E)Experimental Treatment1 Intervention
Multiple ascending doses of LY3971297 administered SC in healthy Japanese participants
Group II: LY3971297 (Part D)Experimental Treatment1 Intervention
Multiple ascending doses of LY3971297 administered SC in participants with obesity and hypertension
Group III: LY3971297 (Part C)Experimental Treatment1 Intervention
Multiple ascending doses of LY3971297 administered SC in healthy Chinese participants
Group IV: LY3971297 (Part B)Experimental Treatment1 Intervention
Multiple ascending doses of LY3971297 administered SC in healthy participants
Group V: LY3971297 (Part A)Experimental Treatment1 Intervention
Single ascending doses of LY3971297 administered subcutaneously (SC) in healthy participants
Group VI: PlaceboPlacebo Group1 Intervention
Placebo administered SC

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,640 Previous Clinical Trials
3,221,456 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,358 Previous Clinical Trials
417,902 Total Patients Enrolled
~58 spots leftby Feb 2025
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