LY3473329 for Kidney Function

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

47 Participants Needed

Trial Summary

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.

How does the drug LY3473329 differ from other treatments for kidney function?

LY3473329, also known as FTY720, is unique because it is a sphingosine-1-phosphate receptor agonist, which helps modulate the movement of immune cells, potentially reducing kidney damage without the side effects of traditional immunosuppressants. This mechanism is different from other treatments that may directly suppress the immune system, offering a novel approach to managing kidney function. ^{1 2 3 4 5}

What is the purpose of this trial?

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 into the bloodstream and how quickly it is removed from the body. The goal is to ensure the drug is safe and effective for everyone.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. China pubmed.ncbi.nlm.nih.gov

[Effect of FTY720 on glomerulosclerosis and expression of cell cycle regulatory proteins in subtotally nephrectomized rats]. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

FTY720, a novel immunomodulator: efficacy and safety results from the first phase 2A study in de novo renal transplantation. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

FTY720, a novel immunomodulator: efficacy and safety results from the first phase 2A study in de novo renal transplantation. [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

FTY720 in combination with cyclosporine--an analysis of skin allograft survival and renal function. [2015]

5. England pubmed.ncbi.nlm.nih.gov

FTY720, a novel immunomodulator in de novo kidney transplant patients: pharmacokinetics and exposure-response relationship. [2022]