LY3537982 for Kidney Problems

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

Must not be taking: Immunosuppressives

Disqualifiers: Chronic liver disease, Renal transplant, Malignancy, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the right dose of LY3537982, an experimental drug, for individuals with kidney issues, particularly severe kidney problems. Participants will take LY3537982 orally, and the study will last about 43 days for each person. The trial includes groups based on kidney function: normal, moderate, and severe impairment. Ideal participants have kidney problems but are not on dialysis and have stable blood pressure. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance 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. However, it mentions that up to 2 grams per day of acetaminophen is allowed during the study.

Is there any evidence suggesting that LY3537982 is likely to be safe for humans?

Researchers are currently determining the right dose of LY3537982 for individuals with kidney problems. Detailed safety information about this new treatment remains limited. As the study is in its early stages, the primary focus is on identifying a safe dosage, with safety being closely monitored.

In these early trials, researchers primarily look for side effects to assess how well participants tolerate the treatment. While solid evidence may not yet exist, any serious side effects typically lead to adjustments in the study's conduct.

If LY3537982 receives approval for another condition, it could suggest its safety. However, the current goal is to ensure its safety for individuals with varying levels of kidney function. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for kidney problems, which often include dialysis or medications like ACE inhibitors and ARBs, LY3537982 is unique because it is administered orally and targets different stages of renal function impairment. Researchers are excited about LY3537982 because it offers a potential new way to manage kidney issues by being suitable for patients with normal, moderate, or severe renal impairment. This versatility and method of delivery could make it more convenient and accessible, providing a fresh approach where current options might fall short.

What evidence suggests that LY3537982 might be an effective treatment for kidney problems?

Research is investigating LY3537982 as a potential treatment for serious kidney problems. The trial includes different arms to study the effects of LY3537982 on patients with varying levels of kidney function, including normal renal function, moderate renal impairment, and severe renal impairment. This treatment targets specific aspects of kidney health to aid those with severe kidney issues. While the effectiveness is still under evaluation, early studies are examining its efficacy and optimal dosage. The ongoing research aims to confirm its potential benefits and ensure safety for patients with different levels of kidney impairment. ^{2 3 4 6 7}

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 moderate to severe kidney problems who have a BMI of 19.0-42.0 kg/m², stable blood pressure, and pulse rate. They must not be on dialysis or have had certain cancers in the last 5 years, no hepatitis B/C or HIV, no known allergies to LY3537982, and agree to contraception if applicable.

Inclusion Criteria

Have a body mass index (BMI) within the range 19.0 to 42.0 kilograms per square meter (kg/m²), inclusive

My kidney function is moderately reduced.

I have never been on hemodialysis or peritoneal dialysis.

Exclusion Criteria

Have evidence of hepatitis B at screening, that is, positive test for hepatitis B surface antigen, HBV DNA, or both

I am pregnant or breastfeeding.

Have known allergies to LY3537982, related compounds or any components of the formulation, or a history of significant atopy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive a single dose of LY3537982 to assess pharmacokinetics

1 day

Observation

Participants are monitored for pharmacokinetic analysis and safety assessments

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• LY3537982

Trial Overview

The study tests the appropriate dose of a new medication called LY3537982 for people with different levels of kidney function over approximately 43 days. It aims to find safe dosing for those with severe renal impairment without requiring dialysis.

How Is the Trial Designed?

Group I: LY3537982 (Severe renal impairment) Experimental Treatment 1 Intervention

LY3537982 administered orally.

Group II: LY3537982 (Normal renal function) Experimental Treatment 1 Intervention

LY3537982 administered orally.

Group III: LY3537982 (Moderate renal impairment) Experimental Treatment 1 Intervention

LY3537982 administered orally.

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

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Eli Lilly's New Study on LY3537982: A Potential Game ...

The study aims to determine the appropriate dosage of LY3537982 for individuals with varying degrees of kidney problems, focusing on those with ...

2.

delta.larvol.com

delta.larvol.com/Products/?ProductId=65d97bf4-8b77-442d-af72-27d99b9c59ac

olomorasib (LY3537982) / Eli Lilly

Delicious. October 21, 2025. A Study of LY3537982 in Participants With Kidney Problems Compared With Participants With Normal Kidney Function (clinicaltrials ...

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lilly.gcs-web.com

lilly.gcs-web.com/news-releases/news-release-details/lilly-announces-details-presentations-2021-american-association

Lilly Announces Details of Presentations at 2021 American ...

The incidences of renal failure in clinical studies in which patients received ALIMTA with cisplatin were 2.1% in Study JMDB and 2.2% in Study JMCH. The ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11572139/

An updated overview of K-RAS G12C inhibitors in advanced ...

In this review we summarized the results of recent clinical trials, focusing on the efficacy and safety profile of KRAS G12C inhibitors. 2. KRAS mutation ...

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go.drugbank.com

go.drugbank.com/conditions/DBCOND0038927

Impaired Renal Function (DBCOND0038927)

A Study of LY3537982 in Participants With Kidney Problems Compared With Participants With Normal Kidney Function ... Kidney Function on Postoperative Outcome ...

6.

patlynk.com

patlynk.com/trial/NCT07137689

LY3537982 Dosing in Renal Impairment

The study aims to find the correct dose of a new drug, LY3537982, for people who have kidney problems, especially those with severe kidney issues.

7.

investor.lilly.com

investor.lilly.com/news-releases/news-release-details/lilly-announces-details-presentations-2021-american-association

Lilly Announces Details of Presentations at 2021 American ...

ALIMTA can cause severe, and sometimes fatal, renal toxicity. Determine creatinine clearance before each dose and periodically monitor renal function during ...