Eloralintide for Kidney Disease

Not currently recruiting at 1 trial location
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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 tests a new treatment called Eloralintide, a potential new drug, to determine its absorption into the bloodstream and the rate at which the body eliminates it. The trial focuses on individuals with kidney problems and those with healthy kidneys. Participants may qualify if they have stable kidney issues or are on regular dialysis. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are in Groups 2 or 3, you must have been on a stable dose of any medication for your kidney condition for at least 7 days before starting the trial.

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

Research has shown that Eloralintide, a drug mimicking a hormone to control blood sugar and appetite, has been generally well-tolerated in previous studies. In one study with repeated doses, participants experienced few problems. Most side effects were mild, such as nausea and headache, which are common with similar medications and usually easy to manage. As this is an early-phase study, the main goal is to assess safety, and Eloralintide appears safe for people so far. However, more studies are needed to confirm these findings.12345

Why do researchers think this study treatment might be promising for kidney disease?

Unlike current treatments for kidney disease, which often include medications like ACE inhibitors and ARBs to manage symptoms, Eloralintide offers a new approach. Eloralintide is administered subcutaneously and is specifically designed to target impaired renal function. Researchers are excited about Eloralintide because it introduces a novel mechanism of action, potentially improving kidney function even in patients with end-stage renal disease on dialysis. This could offer a significant improvement in treatment effectiveness and quality of life for patients with severe kidney conditions.

What evidence suggests that Eloralintide might be an effective treatment for kidney disease?

Research has shown that Eloralintide targets specific parts of the body to help manage conditions like kidney disease. Early studies found that Eloralintide can be safely administered to patients with kidney problems and is generally well-tolerated. In this trial, participants will receive Eloralintide in groups based on their renal function, including those with impaired renal function and those with end-stage renal disease on stable hemodialysis. Researchers have observed encouraging results regarding its absorption into the bloodstream and overall safety. While more information about its effects on kidney disease is still being gathered, Eloralintide's mechanism suggests it could be beneficial for managing kidney-related conditions.12356

Who Is on the Research Team?

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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 either severe kidney problems (including those on stable dialysis) or healthy kidneys. Participants must have stable blood pressure, no serious history of low blood sugar, weigh at least 55 kg, and meet specific lab criteria. People with uncontrolled diabetes or unstable health cannot join.

Inclusion Criteria

My blood pressure and pulse rate are within a healthy range.
* Have no significant history of spontaneous or ethanol-induced hypoglycemia
My weight is at least 55 kg and my BMI is between 19.0 and 40.0.
See 6 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 dose of Eloralintide administered subcutaneously

1 day

Follow-up

Participants are monitored for pharmacokinetics and safety over the study period

14 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Eloralintide (LY3841136)

Trial Overview

The study tests how the drug Eloralintide (LY3841136), given as an injection under the skin, behaves in people with severe kidney disease compared to those with normal kidney function. The study lasts about 14 weeks per participant.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Eloralintide (Groups 2 and 3)Experimental Treatment1 Intervention
Group II: Eloralintide (Group 3)Experimental Treatment1 Intervention
Group III: Eloralintide (Group 1)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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Here, we report the results of a phase 2 trial evaluating the efficacy and safety of a range of doses and dose escalation schemes of once-per- ...

Eloralintide for Kidney Disease

This Phase 1 medical study run by Eli Lilly and Company is evaluating whether Eloralintide (LY3841136) will have tolerable side effects & efficacy for ...