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Monoclonal Antibodies

LY3875383 for High Triglycerides

Phase 1
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 72 hours post dose
Awards & highlights

Study Summary

This trial studies the safety and effectiveness of a single injection of LY3875383 in healthy people and those with high triglycerides. It looks at how quickly the drug enters and leaves the body.

Who is the study for?
This trial is for healthy individuals and those with high triglycerides. Men must agree to use contraception, women should not be of childbearing potential. Participants need a BMI between 18.5-40 kg/m², and depending on the study part, have specific levels of triglycerides or LDL cholesterol and may need to be on stable lipid-lowering drugs or statins.Check my eligibility
What is being tested?
The study tests LY3875383's tolerability as a single under-the-skin injection in comparison to a placebo. It will check how quickly it enters the bloodstream and its elimination rate from the body over four parts (A-D), lasting up to about 28-56 weeks including screening.See study design
What are the potential side effects?
While specific side effects are not listed, common reactions might include irritation at the injection site, general discomfort, allergic reactions or systemic effects due to changes in lipid metabolism caused by LY3875383.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 72 hours post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 72 hours post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
PK: Maximum Observed Concentration (Cmax) of LY3875383
Triglycerides
Part D only: PD: Percentage Change from Baseline in Fasting Non-High-Density Lipoprotein Cholesterol (HDL-C)
+1 more

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3875383 (Part D)Experimental Treatment1 Intervention
Single doses of LY3875383 administered SC.
Group II: LY3875383 (Part C)Experimental Treatment1 Intervention
Single doses of LY3875383 administered SC.
Group III: LY3875383 (Part B)Experimental Treatment1 Intervention
Single doses of LY3875383 administered SC.
Group IV: LY3875383 (Part A)Experimental Treatment1 Intervention
Single-ascending doses of LY3875383 administered subcutaneously (SC).
Group V: Placebo (Part B)Placebo Group1 Intervention
Placebo administered SC.
Group VI: Placebo (Part A)Placebo Group1 Intervention
Placebo administered SC.
Group VII: Placebo (Part C)Placebo Group1 Intervention
Placebo administered SC.
Group VIII: Placebo (Part D)Placebo Group1 Intervention
Placebo administered SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3875383
2022
Completed Phase 1
~50

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
2,615 Previous Clinical Trials
3,201,017 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,211 Total Patients Enrolled

Media Library

LY3875383 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05609825 — Phase 1
High Triglycerides Research Study Groups: LY3875383 (Part A), LY3875383 (Part B), Placebo (Part B), LY3875383 (Part C), LY3875383 (Part D), Placebo (Part A), Placebo (Part C), Placebo (Part D)
High Triglycerides Clinical Trial 2023: LY3875383 Highlights & Side Effects. Trial Name: NCT05609825 — Phase 1
LY3875383 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05609825 — Phase 1
High Triglycerides Patient Testimony for trial: Trial Name: NCT05609825 — Phase 1

Frequently Asked Questions

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

Has LY3875383 (Part B) successfully met the criteria for FDA approval?

"Due to the limited evidence backing LY3875383's (Part B) safety and efficacy, our organisation has allocated it a score of 1 on a scale from 1-3."

Answered by AI

What is the maximum capacity of participants for this clinical trial?

"In order to complete this trial, Eli Lilly and Company needs a total of 120 participants who meet the inclusion criteria. These patients will be recruited at two sites: Endeavor Clinical Trials in San Antonio, Texas; Altasciences Clinical Los Angeles Inc in Cypress California."

Answered by AI

Does this research endeavor include elderly individuals in its recruitment pool?

"According to the delineated inclusion criteria, individuals between 18 and 70 are eligible for this medical trial. There is an additional 1 study available for minors, whereas those over 65 can choose from 14 different trials."

Answered by AI

How many sites have been enlisted to execute this research endeavor?

"Five distinct medical centres are eligible for the trial, such as Endeavour Clinical Trials in San Antonio, Altasciences Clinical Los Angeles, Inc. based in Cypress, and ProSciento Inc located in Chula Vista."

Answered by AI

Is this medical experiment currently available to the public?

"Clinicaltrials.gov reveals that this experiment is actively recruiting volunteers, with the first post being made on November 14th 2022 and last updated two weeks later on November 29th 2022."

Answered by AI

Who meets the criteria to be eligible for this research project?

"This clinical trial is recruiting 120 individuals, aged between 18 and 70 years, who suffer from hypertriglyceridemia. Essential criteria for enrollment include: a body mass index of 18.5 to 40 kg/m2 inclusive; males agreeing to contraceptive requirements or women not capable of bearing children; overt healthiness based on medical evaluations; exclusive Japanese descent with all grandparents born in Japan; a triglyceride level ranging between 500 mg/dL and 2000 mg/dL that must be confirmed at screening; adherence to lipid-modifying diets as well as stable doses of LLDs eight weeks prior to the commencement of the study period and beyond"

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Altasciences Clinical Los Angeles, Inc
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

Why did patients apply to this trial?

My Dr. told me if I didnt get this under control I was going to die.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia
2022. "A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05609825.
~17 spots leftby Apr 2025
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