LY3885125 for Non-Alcoholic Fatty Liver Disease/Dyslipidemia

No longer recruiting at 1 trial location

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 not be taking: GLP-1 RA, PCSK9 agents

Disqualifiers: Cardiovascular, Diabetes, Hypertension, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY3885125 to assess its safety and tolerability. The study targets two conditions: dyslipidemia, which involves unhealthy fat levels in the blood, and non-alcoholic fatty liver disease (NAFLD), characterized by fat buildup in the liver not caused by alcohol. Participants will receive either single or multiple doses of LY3885125 or a placebo for comparison. Ideal candidates have lived with dyslipidemia or NAFLD and maintained a stable diet for at least three months. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive it.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken certain drugs like those associated with liver issues or specific diabetes medications recently. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that LY3885125 is likely to be safe for humans?

Research has shown that LY3885125 is being tested for safety in individuals with abnormal blood fat levels and non-alcoholic fatty liver disease. Specific information on side effects is not yet available because the study remains in an early stage. Early-stage trials assess how well participants tolerate the treatment.

As a new drug, researchers are closely monitoring for any negative effects. Participants will receive either a single dose or multiple doses to observe their body's reactions. While detailed safety information is not yet available, the current phase of the trial is dedicated to thoroughly evaluating safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for non-alcoholic fatty liver disease and dyslipidemia?

Unlike the standard treatments for non-alcoholic fatty liver disease (NAFLD) and dyslipidemia, which often include lifestyle changes and medications like statins, LY3885125 offers a different approach. This new treatment is administered subcutaneously, meaning it's injected under the skin, which can provide a more direct and potentially more effective delivery compared to oral medications. Researchers are particularly excited because LY3885125 may work through a novel mechanism of action that targets specific pathways involved in lipid metabolism, potentially leading to improved liver health and better management of blood lipid levels. This could offer hope for patients who haven't responded well to existing therapies.

What evidence suggests that LY3885125 might be an effective treatment for non-alcoholic fatty liver disease and dyslipidemia?

Research shows that LY3885125 is a new treatment under testing for high levels of fats in the blood (dyslipidemia) and fat buildup in the liver (non-alcoholic fatty liver disease, or NAFLD). Participants in this trial will receive either single ascending doses, repeat doses of LY3885125, or a placebo. Although specific results on its effectiveness are not yet available, the drug targets the processes involved in these conditions. LY3885125 aims to manage these issues by potentially regulating these processes. Early signs from studies on similar conditions appear promising, but further research is needed to confirm its effectiveness. ^{1 2 3 6 7}

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 adults with dyslipidemia or NAFLD who've been on a stable diet. For dyslipidemia, they need certain blood levels and a BMI of 18.5-45 kg/m2; for NAFLD, liver fat ≥8% by MRI and BMI of 27-45 kg/m2. Exclusions include uncontrolled high blood pressure, recent weight changes >5kg, specific medication use, and other chronic diseases.

Inclusion Criteria

I have NAFLD with liver fat ≥8% and my BMI is between 27 and 45.

I have dyslipidemia and my BMI is between 18.5 and 45.0.

On a stable diet for the 3 months prior to randomization and willing to continue the same stable diet during the study

Exclusion Criteria

I have taken medication linked to fatty liver disease for over 2 weeks in the last 3 months.

I haven't taken certain medications in the last 9 months.

I haven't started or changed any medication that affects my weight significantly in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (Part A)

Participants with dyslipidemia receive single ascending doses of LY3885125 or placebo

49 weeks

Treatment (Part B)

Participants with NAFLD receive repeat doses of LY3885125 or placebo

62 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3885125

Trial Overview The study tests LY3885125's safety in single (part A) and multiple doses (part B) against a placebo in people with dyslipidemia or NAFLD. It measures how the body absorbs and eliminates the drug over roughly 49 weeks for part A and up to 62 weeks for part B.

How Is the Trial Designed?

Group I: LY3885125 (Part B) Experimental Treatment 1 Intervention

Repeat doses of LY3885125 administered SC

Group II: LY3885125 (Part A) Experimental Treatment 1 Intervention

Single ascending doses of LY3885125 administered subcutaneously (SC)

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

Placebo administered SC

Group IV: Placebo (Part B) 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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06007651

NCT06007651 | A Study of LY3885125 in Participants With ... The main purpose of this study is to evaluate the safety and tolerability of LY3885125 after administration of single ascending doses in participants with ...

2. withpower.com withpower.com/trial/phase-1-liver-diseases-7-2023-504a6

LY3885125 for Non-Alcoholic Fatty Liver Disease ... This trial is testing a new drug called LY3885125 to see if it is safe and well-tolerated. It involves people with dyslipidemia and non-alcoholic fatty ...

3. ctv.veeva.com ctv.veeva.com/study/a-study-of-ly3885125-in-participants-with-dyslipidemia-or-non-alcoholic-fatty-liver-disease-nafld

A Study of LY3885125 in Participants with Dyslipidemia or ... The main purpose of this study is to evaluate the safety and tolerability of LY3885125 after administration of single ascending doses in participants with ...

4. barchart.com barchart.com/story/news/30493448/nonalcoholic-fatty-liver-disease-pipeline-2024-key-companies-moa-roa-and-clinical-trials-evaluation-by-delveinsight-eli-lilly-and-company-pfizer-boehringer-ingelheim-astrazeneca-inventiva

Non-Alcoholic Fatty Liver Disease Pipeline 2024 The MAESTRO-NASH OUTCOMES study is a double-blind, randomized, placebo-controlled Phase III trial that includes 845 patients with compensated NASH cirrhosis and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12407576/

Evidence From a Systematic Review of Non-alcoholic Fatty ... The synthesis focused on describing the observed associations between NAFLD and various cardiovascular outcomes. Key characteristics of the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12321477/

MASLD development: From molecular pathogenesis toward ... A Study of LY3885125 in Participants with Dyslipidemia or NAFLD ... safety of efinopegdutide in patients with non-alcoholic fatty liver disease.

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0161012

Metabolic Dysfunction-associated Steatohepatitis (MASH) ... ... LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD) ... Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver ...