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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
Summary
This trial is testing a new drug called LY3875383, given as a single injection under the skin. It aims to see if the drug is safe and what side effects it might have. The study includes both healthy people and those with high levels of triglycerides, a type of fat in the blood. Researchers will also measure how quickly the drug gets into the bloodstream and how long it stays there.
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose up to 72 hours post dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 72 hours post dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Therapeutic procedure
Secondary study objectives
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 moreTrial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for high triglycerides work through various mechanisms to reduce triglyceride levels in the blood. Lifestyle modifications, such as diet and exercise, are foundational and help by reducing overall fat intake and increasing metabolism.
Medications like fibrates activate peroxisome proliferator-activated receptors (PPARs) to increase the oxidation of fatty acids and reduce triglyceride synthesis. Omega-3 fatty acids decrease triglyceride production in the liver and increase their clearance from the blood.
Niacin reduces the liver's production of triglycerides and very-low-density lipoprotein (VLDL). Statins primarily lower cholesterol but also have a modest effect on triglycerides by inhibiting HMG-CoA reductase, reducing the liver's production of cholesterol and triglycerides.
These mechanisms are crucial for patients with high triglycerides as they help prevent complications such as pancreatitis and cardiovascular disease by lowering the risk associated with elevated triglyceride levels.
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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
2,651 Previous Clinical Trials
3,224,426 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,369 Previous Clinical Trials
421,353 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of very high triglyceride levels, and you need to be on a specific diet and medication for at least 8 weeks before joining the study.You must have a history of high triglyceride levels and specific cholesterol levels, be on a stable dose of a specific medication for at least 8 weeks, and plan to continue this medication throughout the study.You should not drink a lot of alcohol or smoke cigarettes.You have not had pancreatitis in the last 6 months.Your body mass index (BMI) must be between 18.5 and 40.
Research Study Groups:
This trial has the following groups:- Group 1: LY3875383 (Part A)
- Group 2: LY3875383 (Part B)
- Group 3: Placebo (Part B)
- Group 4: LY3875383 (Part C)
- Group 5: LY3875383 (Part D)
- Group 6: Placebo (Part A)
- Group 7: Placebo (Part C)
- Group 8: Placebo (Part D)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
High Triglycerides Patient Testimony for trial: Trial Name: NCT05609825 — Phase 1
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