LY3537031 for Kidney Failure

Recruiting at 3 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

Disqualifiers: Chronic liver disease, Hepatitis, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY3537031 to understand its behavior in the body, specifically its absorption into the bloodstream and rate of elimination. It targets individuals with kidney issues, including those on dialysis, and includes a comparison group with normal kidney function. Participants should have stable severe kidney problems or be undergoing dialysis, without a history of liver disease or recent cancer. 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 drug.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that LY3537031 is likely to be safe for humans?

Research is testing LY3537031 for kidney failure to determine how much of the drug enters the bloodstream and how the body processes it. This study is in its early stages, so limited safety information is available. Researchers closely monitor serious side effects in early-stage treatments to ensure safety. If LY3537031 had approval for another condition, it might suggest safety, but that is not the case here. Participants should understand that not all potential risks are fully known at this stage. ^{1 2 3 4 5}

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

Unlike the standard treatments for kidney failure, which often include medications like ACE inhibitors, ARBs, or dialysis, LY3537031 is administered subcutaneously and is being explored for its potential to act directly on renal function. Researchers are excited about LY3537031 because it offers a new delivery method that could provide a more targeted approach, potentially leading to better outcomes for patients with impaired renal function, including those with end-stage renal disease on hemodialysis. This novel treatment could pave the way for improved management of kidney failure, offering hope for enhanced quality of life.

What evidence suggests that LY3537031 might be an effective treatment for kidney failure?

Research on LY3537031 remains in the early stages, so detailed information on its effectiveness in people is not yet available. This trial will study LY3537031 in different groups: one with normal renal function, another with impaired renal function, and a third with end-stage renal disease on hemodialysis. The treatment aims to assist with kidney failure by improving the body's handling of the condition. Scientists believe it enhances drug absorption and removal in individuals with varying kidney functions. Early lab tests show promise, but solid evidence on its effectiveness in treating kidney failure in people is still lacking. Currently, the main goal is to understand how it behaves in the body to prepare for future studies. ^{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 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 varying levels of kidney function, from normal to severely impaired. It's also open to healthy participants. Key exclusions include pregnant or breastfeeding individuals, those with unstable medical conditions, and people on certain medications that could affect the study.

Inclusion Criteria

Have no significant history of spontaneous or ethanol-induced hypoglycemia

Additional Inclusion Criteria for Healthy Participants in Control Group: Have glycated hemoglobin (HbA1c) less than or equal to 6.5% at screening

My weight is at least 55 kg and my BMI is between 19.0 and 40.0.

Exclusion Criteria

I have a history of liver disease or hepatitis.

I have a working kidney transplant.

I was diagnosed with cancer within the last 5 years.

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 LY3537031

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics and safety of LY3537031

8 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LY3537031

Trial Overview The trial is testing LY3537031 in participants to see how the drug behaves in their bodies—how much gets into the bloodstream and how quickly it's eliminated—especially focusing on differences between those with kidney issues and healthy volunteers.

How Is the Trial Designed?

Group I: LY3537031 (Groups 2-3) Experimental Treatment 1 Intervention

LY3537031 administered SC in groups of participants with impaired renal function

Group II: LY3537031 (Group 3) Experimental Treatment 1 Intervention

LY3537031 administered SC in a group of participants with end-stage renal disease (ESRD) on hemodialysis

Group III: LY3537031 (Group 1) Experimental Treatment 1 Intervention

LY3537031 administered subcutaneously (SC) in a control group of participants with normal renal function

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/NCT07165015

NCT07165015 | A Study of Pharmacokinetics and Safety of ... The purpose of this study is to assess the amount of LY3537031 that reaches the bloodstream and the time it takes for the body to get rid of it when given to ...

2. trials.lilly.com trials.lilly.com/en-US/trial/650580

A Study of Pharmacokinetics and Safety of LY3537031 in ... The purpose of this study is to assess the amount of LY3537031 that reaches the bloodstream and the time it takes for the body to get rid of it ...

3. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/35082822/eli-lillys-new-study-on-ly3537031-a-potential-game-changer-for-renal-impairment-treatment/

Eli Lilly's New Study on LY3537031: A Potential Game ... The study aims to understand how LY3537031 is processed in the body of individuals with varying levels of kidney function, including those with ...

4. withpower.com withpower.com/trial/phase-1-renal-insufficiency-8-2025-7031c

LY3537031 for Kidney Failure The purpose of this study is to assess the amount of LY3537031 that reaches the bloodstream and the time it takes for the body to get rid of it when given ...

5. decentrialz.com decentrialz.com/clinical-trials/NCT07165015/A%20Study%20of%20Pharmacokinetics%20and%20Safety%20of%20LY3537031%20in%20Participants%20With%20Normal%20Renal%20Function%20and%20Participants%20With%20Renal%20Impairment

A Study of Pharmacokinetics and Safety of LY3537031 in ... The purpose of this study is to assess the amount of LY3537031 that reaches the bloodstream and the time it takes for the body to get rid of it when given ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0035540

End Stage Renal Disease (ESRD) (DBCOND0035540) NCT07165015. A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment. LY3537031.