LY3875383 for High Triglycerides

No longer recruiting at 5 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must be taking: Lipid-lowering drugs, Statins

Disqualifiers: Viral infections, Heavy drinkers, Smokers, others

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY3875383 for individuals with high triglycerides (a type of fat in the blood) to assess its tolerability and potential side effects. Researchers are also examining the drug's absorption rate into the bloodstream and the duration it takes for the body to clear it. Participants will receive either a single dose of LY3875383 or a placebo (a substance with no therapeutic effect) via an injection under the skin. The trial is open to healthy individuals and those with high triglycerides who have managed their condition with diet or medication for at least eight weeks. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

If you are participating in Part C or D of the trial, you must continue taking your current lipid-lowering drugs or statins at the same dose throughout the study. The protocol does not specify medication requirements for other parts of the trial.

Is there any evidence suggesting that LY3875383 is likely to be safe for humans?

Research shows that LY3875383 is being tested for safety in humans. In this trial, participants will receive a single injection under the skin. As an early-stage trial, the main goal is to assess treatment tolerance and identify potential side effects.

Limited information exists on LY3875383 due to its early testing phase, so reactions remain largely unknown. Early trials focus on detecting immediate and noticeable side effects. Researchers will closely monitor participants to observe their body's response to the treatment.

Prospective participants should understand that this trial primarily aims to determine if LY3875383 is safe for further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LY3875383 because it targets high triglycerides in a potentially new way. Unlike standard treatments like fibrates or omega-3 fatty acids, which often work by reducing the liver's production of triglycerides, LY3875383 is delivered subcutaneously and may offer a novel mechanism of action that could enhance its effectiveness. This innovative approach might provide faster or more significant results, offering a fresh hope for those struggling with high triglycerides.

What evidence suggests that LY3875383 might be an effective treatment for high triglycerides?

Research has shown that LY3875383, which participants in this trial may receive, is under study for its potential to lower high triglyceride levels. Triglycerides, a type of fat in the blood, can increase the risk of heart disease. LY3875383 is a new treatment injected under the skin, aiming to manage these fat levels. It is still being tested to determine its effectiveness and safety. Although limited data exists, the expected mechanism of LY3875383 suggests it could be a promising option for people with high triglycerides. ^{1 2 3 4 6}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP)

For Part B: Participants must be first-generation Japanese, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan

Exclusion Criteria

All participants must not have one of the following viral infections: hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV)

All participants must not be currently participating in or completed a clinical trial within the last 30 days

All participants must not have donated blood of more than 500 mL within the previous 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of LY3875383 or placebo administered subcutaneously

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3875383
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: LY3875383 (Part D) Experimental Treatment 1 Intervention

Single doses of LY3875383 administered SC.

Group II: LY3875383 (Part C) Experimental Treatment 1 Intervention

Single doses of LY3875383 administered SC.

Group III: LY3875383 (Part B) Experimental Treatment 1 Intervention

Single doses of LY3875383 administered SC.

Group IV: LY3875383 (Part A) Experimental Treatment 1 Intervention

Single-ascending doses of LY3875383 administered subcutaneously (SC).

Group V: Placebo (Part B) Placebo Group 1 Intervention

Placebo administered SC.

Group VI: Placebo (Part A) Placebo Group 1 Intervention

Placebo administered SC.

Group VII: Placebo (Part C) Placebo Group 1 Intervention

Placebo administered SC.

Group VIII: Placebo (Part D) Placebo Group 1 Intervention

Placebo administered SC.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

SC401, a new ω-3 fatty acid formulation, demonstrated significantly higher bioavailability of EPA and DHA compared to Lovaza, achieving this with a lower dose of 1530 mg versus Lovaza's 3600 mg.

The study found that SC401 had a faster absorption rate, with a shorter time to peak concentration (Tmax) compared to Lovaza, indicating it may be more effective in delivering these essential fatty acids under low-fat feeding conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel ω-3 Acid Ethyl Ester Formulation Incorporating Advanced Lipid TechnologiesTM (ALT®) Improves Docosahexaenoic Acid and Eicosapentaenoic Acid Bioavailability Compared with Lovaza®. Lopez-Toledano, MA., Thorsteinsson, T., Daak, A., et al.[2019]

Hypertriglyceridemia is a significant risk factor for cardiovascular disease and acute pancreatitis, highlighting the need for effective treatments beyond existing options like fibrates and ω-3 fatty acids.

Novel therapies, including apolipoprotein C-III inhibitors and fibroblast growth factor 21 analogues, are currently in early clinical development to better manage very high triglyceride levels and reduce cardiovascular risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Investigational and Experimental Therapeutics for the Treatment of Hypertriglyceridemia. Parthymos, I., Kostapanos, MS., Liamis, G., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05609825

A Study of LY3875383 in Healthy Participants and ... The main purpose of this study is to determine the tolerability and side effects related to LY3875383 given as a single injection under the skin to healthy ...

2. withpower.com withpower.com/trial/phase-1-hypertriglyceridemia-10-2022-e351e

LY3875383 for High Triglycerides · Info for Participants Research shows that treatments like icosapent ethyl, which is an omega-3 fatty acid, have significantly reduced cardiovascular events in patients with high ...

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05609825?keyword=%22Hypertriglyceridemia%22

San Mateo Clinical Trial A Study of LY3875383 in Healthy ... The main purpose of this study is to determine the tolerability and side effects related to LY3875383 given as a single injection under the skin to healthy ...

4. barchart.com barchart.com/story/news/32866920/hypertriglyceridemia-pipeline-2025-key-developments-emerging-therapies-and-clinical-trials-detailed-analysis-by-delveinsight-merck-julphar-eli-lilly-and-company-bristolmyers-squibb-company

Hypertriglyceridemia Pipeline 2025: Key Developments ... Emerging Hypertriglyceridemia therapies in the different phases of clinical trials are- LY3875383, TLC-2716, MAR001, ARO-APOC3, NST-1024, ...

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0044916

Hypertriglyceridemias (DBCOND0044916) A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides. Atorvastatin · Torcetrapib. treatment ...

6. malacards.org malacards.org/card/hypertriglyceridemia_1

Hypertriglyceridemia 1 (HYTG1) Hypertriglyceridemia is the presence of high amounts of triglycerides in the blood. Triglycerides are the most abundant fatty molecule in most organisms.