← Back to Search

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
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

Study Summary

This trial will measure the side effects of a drug injected under the skin on healthy and obese participants with high BP. Blood tests will monitor the drug in the body over 90 days.

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.Check my eligibility
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.See study design
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
Select...
I am a man who agrees to follow contraception rules or a woman who cannot become pregnant.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,620 Previous Clinical Trials
3,216,411 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,557 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of candidate is best suited for inclusion in this research effort?

"This clinical trial is accepting a total of 188 individuals who are between ages 18 and 65, have high blood pressure, and meet the other criteria."

Answered by AI

Is enrollment still available for this clinical trial?

"As per clinicaltrials.gov, this trial has suspended recruitment efforts since November 20th 2023 and is not looking for new patients at present. However, there are numerous other trials with open enrolment currently available; 2605 to be exact."

Answered by AI

Does this trial accept participants of an advanced age?

"This clinical trial seeks individuals aged 18-65. The database lists 301 trials that are suitable for those younger than 18 while 1,717 entries can be found for patients above 65 years of age."

Answered by AI

Has LY3971297 (Part C) been granted the sanction of official approval by the FDA?

"The safety of LY3971297 (Part C) was rated a 1 as this is still an early phase clinical trial with limited efficacy and safety data collected."

Answered by AI

Who else is applying?

What site did they apply to?
ICON Early Phase Services
CenExel ACT
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Tired of being fat. Diet and exercise together haven’t allowed me to reach a weight below overweight/obese.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of LY3971297 in Healthy Participants and Participants With Obesity and Hypertension
2023. "A Study of LY3971297 in Healthy Participants and Participants With Obesity and Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06148272.
~104 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top