What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include lipid-lowering agents like statins, which are generally well-tolerated but can cause muscle pain, liver enzyme abnormalities, and, rarely, rhabdomyolysis. Orlistat, another treatment, primarily causes gastrointestinal side effects such as oily stools, flatulence, and frequent bowel movements. Pioglitazone, used for its insulin-sensitizing effects, can lead to weight gain, edema, and an increased risk of heart failure. These treatments aim to reduce liver fat and improve liver function, but their side effects should be carefully monitored.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD). Current management primarily focuses on lifestyle modifications such as diet and exercise. However, several drugs are under investigation, including those targeting lipid metabolism, insulin resistance, and inflammation, similar to the investigational drug LY3885125, which is being evaluated for its safety, tolerability, and pharmacokinetics in patients with dyslipidemia and NAFLD.

What other types of research exist?

Promising alternatives to LY3885125 for NAFLD treatment include NGM282, which has shown significant improvements in liver fibrosis and histology, and endoscopic bariatric and metabolic therapies (EBMTs), which have demonstrated improvements in hepatic steatosis, alanine aminotransferase levels, and NAFLD activity scores. Both therapies have shown potential in clinical trials and could be considered for treatment in 2024.

← Back to Search

Monoclonal Antibodies

LY3885125 for Non-Alcoholic Fatty Liver Disease/Dyslipidemia

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

Males, or females not of childbearing potential

Be older than 18 years old

Must not have

Uncontrolled hypertension with a resting blood pressure ≥ 160 mmHg systolic or ≥ 100 mmHg diastolic at visit 1

Type 1 diabetes mellitus (T1DM) or any other type of diabetes mellitus other than T2DM

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 49 weeks (part a) and baseline up to 62 weeks (part b)

Summary

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 liver disease. Researchers will measure how much of the drug gets into the blood and how long it stays there.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects may include reactions at the injection site, gastrointestinal issues like nausea or diarrhea, potential liver enzyme elevations, fatigue, headache or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a male or a female who cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My blood pressure is very high and not under control.

Select...

I have diabetes, but it is not type 2.

Select...

I have lost or gained more than 5 kg in the last 3 months.

Select...

My diabetes is not well-managed, with an HbA1c over 9%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 49 weeks (part a) and baseline up to 62 weeks (part b)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 49 weeks (part a) and baseline up to 62 weeks (part b)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 49 weeks (part a) and baseline up to 62 weeks (part b) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Part B: Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration

Secondary study objectives

Part A & B: PD: Change From Baseline in apolipoprotein B (ApoB)

Part A & B: PK: Maximum Observed Plasma Concentration (Cmax) of LY3885125

Part A & B: PK: Time of Maximum Observed Concentration (Tmax) of LY3885125

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3885125 (Part B)Experimental Treatment1 Intervention

Repeat doses of LY3885125 administered SC

Group II: LY3885125 (Part A)Experimental Treatment1 Intervention

Single ascending doses of LY3885125 administered subcutaneously (SC)

Group III: Placebo (Part A)Placebo Group1 Intervention

Placebo administered SC

Group IV: Placebo (Part B)Placebo Group1 Intervention

Placebo administered SC

0 / 5Eligibility criteria met

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 Non-alcoholic Fatty Liver Disease (NAFLD) often target metabolic pathways to reduce liver fat and improve liver function. GLP-1 receptor agonists, for example, enhance insulin secretion, improve glucose and lipid metabolism, and reduce hepatic fat content. Another class, SGLT2 inhibitors, helps manage diabetes and may reduce portal hypertension. Agents like pioglitazone improve insulin sensitivity, while vitamin E acts as an antioxidant to reduce liver inflammation. These mechanisms are crucial for NAFLD patients as they address the underlying metabolic dysfunctions, potentially slowing disease progression and improving liver health.