LY3473329 for Kidney Function

No longer recruiting at 6 trial locations

Overseen By Thomas C Marbury

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Alcohol abuse, Smoking, Anemia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the new drug LY3473329 (an experimental treatment) behaves in the body and assesses its safety for individuals with varying levels of kidney function. Participants will be grouped based on kidney health, ranging from normal function to severe kidney issues. The trial aims to determine how much of the drug enters the bloodstream and how quickly the body processes it. This trial may suit individuals with mild to severe kidney problems who are interested in testing new treatments. As a Phase 1 trial, the research focuses on understanding 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 study team or your doctor.

Is there any evidence suggesting that LY3473329 is likely to be safe for humans?

Research shows that LY3473329 is being tested for safety in people with varying kidney function levels. As this is an early research stage, complete safety information is not yet available. Early trials like this one primarily assess how well participants tolerate a new treatment.

In the first testing phase, the main goal is to evaluate safety and identify any side effects. This phase is crucial for understanding how the drug interacts with the body. If LY3473329 proves safe, it may progress to more advanced stages, where researchers will gather more detailed safety information.

In summary, although extensive safety data for LY3473329 is currently lacking, this testing phase ensures its safety for further study. Trial participants will help researchers collect this vital information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for kidney function issues, which typically include medications like ACE inhibitors, ARBs, or diuretics, LY3473329 is a novel compound that targets kidney function directly. Researchers are excited about LY3473329 because it offers a new approach by potentially improving kidney function across different stages of renal impairment, from mild to end-stage disease. The oral administration of LY3473329 makes it convenient for patients, and its potential to treat a wide spectrum of renal conditions distinguishes it from current options. This versatility and targeted action provide hope for more effective management of kidney issues.

What evidence suggests that LY3473329 might be an effective treatment for kidney function?

Research shows that LY3473329 is a new drug under investigation for its effects on kidney health. While specific data on its impact on kidney function is not yet available, the current trial aims to understand how the drug behaves in the body across various levels of kidney impairment. Participants in this trial will receive LY3473329, and early research examines how much of the drug enters the bloodstream and how quickly it exits. This information is crucial to assess its potential usefulness for individuals with varying degrees of kidney problems. Further testing will help determine its benefits for kidney health. ^{1 2 3 5 6}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 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 kidney function, from normal to impaired. Participants must have a BMI of 19-42 kg/m² and agree to use contraception if applicable. They should not have any conditions that could affect their safety, abnormal ECGs, high blood pressure or pulse rate risks, smoke heavily, recently donated a lot of blood, or consume excessive alcohol.

Inclusion Criteria

Your test results are within the normal range for most people.

I am using or agree to use effective birth control methods.

Your body mass index (BMI) is between 19.0 and 42.0 kilograms per meter squared (kg/m²).

Exclusion Criteria

Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study

I drink more than the recommended weekly alcohol limit.

My hemoglobin is below 8 g/dL or I have symptoms of severe anemia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive oral administration of LY3473329 to assess pharmacokinetics in different renal function groups

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3473329

Trial Overview The study tests LY3473329 in people with different levels of kidney health. It measures how much drug gets into the bloodstream and how quickly the body eliminates it. The trial also looks at the drug's safety and tolerability over up to an eight-week period including screening.

How Is the Trial Designed?

Group I: LY3473329 (Severe Renal Impairment) Experimental Treatment 1 Intervention

LY3473329 administered orally to participants with severe renal impairment

Group II: LY3473329 (Moderate Renal Impairment) Experimental Treatment 1 Intervention

LY3473329 administered orally to participants with moderate renal impairment

Group III: LY3473329 (Mild Renal Impairment) Experimental Treatment 1 Intervention

LY3473329 administered orally to participants with mild renal impairment

Group IV: LY3473329 (End-Stage Renal Disease) Experimental Treatment 1 Intervention

LY3473329 administered orally to participants with end-stage renal disease

Group V: LY3473329 (Control) Experimental Treatment 1 Intervention

LY3473329 administered orally to 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/NCT05778864

A Study of LY3473329 in Participants With Impaired and ... The main purpose of this study is to assess the amount of study drug (LY3473329) that reaches the bloodstream and the time it takes for the body to get rid of ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05778864/a-study-of-ly3473329-in-participants-with-impaired-and-normal-renal-function

A Study of LY3473329 in Participants With Impaired and ... The main purpose of this study is to assess the amount of study drug (LY3473329) that reaches the bloodstream and the time it takes for the ...

3. withpower.com withpower.com/trial/phase-1-renal-insufficiency-2-2023-2d840

LY3473329 for Kidney Function · Info for Participants This trial tests a new medication called LY3473329 to see how it behaves in people with and without kidney problems. It measures how much of the drug gets ...

4. trial.medpath.com trial.medpath.com/clinical-trial/2200270b82b9e125/nct05778864-pharmacokinetics-ly3473329-renal-impairment

A Study of LY3473329 in Participants With Impaired and ... The main purpose of this study is to assess the amount of study drug (LY3473329) that reaches the bloodstream and the time it takes for the body to get rid ...

5. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05778864/

Trial | NCT05778864 The main purpose of this study is to assess the amount of study drug (LY3473329) that reaches the bloodstream and the time it takes for the body to get rid ...

6. clinicaltrials.eu clinicaltrials.eu/inn/ly3473329/

LY3473329: A Promising New Drug in Clinical Trials Studies in participants with kidney problems: Researchers are investigating how the drug behaves in people with various levels of kidney function, from mild ...