Eloralintide for Hepatic Insufficiency

Not yet recruiting at 2 trial locations
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Pi
Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how the drug Eloralintide (LY3841136) functions in individuals with varying levels of liver damage compared to those with healthy livers. Researchers will assess how the body absorbs and processes the drug and will document any side effects. The trial seeks participants with mild, moderate, or severe liver damage, as well as those without liver issues. Individuals with chronic liver problems for over six months may be suitable candidates. The study spans approximately 14 weeks, including a 5-night stay at a research center. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems that participants with stable medical conditions and treatments that don't affect their health or the study can join, but it's best to discuss your specific medications with the study team.

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

Research shows that Eloralintide (LY3841136) has been tested in various situations. Most patients have found the treatment generally easy to handle, with few serious side effects reported. In earlier studies, researchers administered Eloralintide to individuals with different liver health statuses to observe absorption and metabolism.

While detailed safety information from these studies remains limited, the current Phase 1 trial closely monitors any side effects, particularly in individuals with liver issues. Since Eloralintide is still in early testing, researchers continue to learn about its safety. However, the absence of major safety problems in earlier studies is encouraging for potential participants. Always consult a healthcare provider to understand the potential risks and benefits.12345

Why do researchers think this study treatment might be promising for hepatic insufficiency?

Eloralintide is unique because it offers a targeted approach for treating hepatic insufficiency, a condition where the liver can't perform its normal functions. Unlike existing treatments that primarily focus on managing symptoms or complications, Eloralintide is administered subcutaneously and may directly influence liver function, potentially offering a more direct and efficient way to support liver health. Researchers are excited about its potential to address varying degrees of liver impairment—ranging from mild to severe—by adapting the treatment to individual needs, which could lead to more personalized and effective care options for patients.

What evidence suggests that Eloralintide might be an effective treatment for hepatic insufficiency?

Research shows that Eloralintide, also known as LY3841136, targets specific liver processes that might enhance its function. Although limited human data exists on its efficacy for liver issues, its mechanism suggests potential benefits. Early studies of similar treatments have shown promise in reducing liver fat and improving liver health. These findings offer hope that Eloralintide might aid those with liver damage, but further research is necessary to confirm its effectiveness. Participants in this trial will receive Eloralintide, with different arms examining its effects on varying levels of hepatic function, from normal to severe impairment.12367

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 chronic liver damage (mild, moderate, or severe) and healthy individuals. Participants should weigh at least 55 kg with a BMI of 19-40 kg/m². Those with stable medical conditions are eligible if their health won't affect the study.

Inclusion Criteria

I am part of group 2, 3, or 4.
My weight is at least 55 kg and my BMI is between 19.0 and 40.0.
I am part of Group 1.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of Eloralintide and are monitored for pharmacokinetics and tolerability

5 nights
In-patient stay at clinical research unit

Follow-up

Participants are monitored for safety and effectiveness after treatment

8-10 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Eloralintide (LY3841136)

Trial Overview

Researchers are testing LY3841136 in people with varying levels of liver damage and those with healthy livers to see how it's absorbed, used by the body, and any side effects it may cause over a roughly 14-week period including a 5-night clinical stay.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Eloralintide (Severe Hepatic Impairment)Experimental Treatment1 Intervention
Group II: Eloralintide (Normal Hepatic Function)Experimental Treatment1 Intervention
Group III: Eloralintide (Moderate Hepatic Impairment)Experimental Treatment1 Intervention
Group IV: Eloralintide (Mild Hepatic Impairment)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

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Delicious. February 12, 2026. A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.

Obesity Medications: Evidence-Based Management - NCBI

Long-term safety data ... In patients with severe hepatic impairment, certain obesity medications may require dose adjustments or may be ...

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We performed a phase 2, double blind, randomised, placebo-controlled trial with the aim of evaluating the efficacy and safety ... data mining, AI ...