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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 34 days postdose
Awards & highlights
Study Summary
This trial will look at the effects of a study drug on people with & without kidney problems. Safety & tolerability will be measured over 8 weeks.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions related to LY3473329 which may include typical drug-related responses such as nausea, headaches, allergic reactions or other organ-specific issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose up to 34 days postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 34 days postdose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3473329
PK: Maximum observed concentration (Cmax) of LY3473329
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3473329
Trial Design
5Treatment groups
Experimental Treatment
Group I: LY3473329 (Severe Renal Impairment)Experimental Treatment1 Intervention
LY3473329 administered orally to participants with severe renal impairment
Group II: LY3473329 (Moderate Renal Impairment)Experimental Treatment1 Intervention
LY3473329 administered orally to participants with moderate renal impairment
Group III: LY3473329 (Mild Renal Impairment)Experimental Treatment1 Intervention
LY3473329 administered orally to participants with mild renal impairment
Group IV: LY3473329 (End-Stage Renal Disease)Experimental Treatment1 Intervention
LY3473329 administered orally to participants with end-stage renal disease
Group V: LY3473329 (Control)Experimental Treatment1 Intervention
LY3473329 administered orally to participants with normal renal function
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3473329
2021
Completed Phase 2
~350
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,618 Previous Clinical Trials
3,201,512 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,706 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I drink more than the recommended weekly alcohol limit.My hemoglobin is below 8 g/dL or I have symptoms of severe anemia.Your test results are within the normal range for most people.You have any unusual results in your heart's electrical activity, blood pressure, or pulse rate that could make it risky to take part in the study.I am using or agree to use effective birth control methods.You have given more than a pint of blood in the last three months.You smoke more than 10 cigarettes a day or an equivalent amount of other tobacco products.Your body mass index (BMI) is between 19.0 and 42.0 kilograms per meter squared (kg/m²).
Research Study Groups:
This trial has the following groups:- Group 1: LY3473329 (Mild Renal Impairment)
- Group 2: LY3473329 (Control)
- Group 3: LY3473329 (Severe Renal Impairment)
- Group 4: LY3473329 (End-Stage Renal Disease)
- Group 5: LY3473329 (Moderate Renal Impairment)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I be eligible to join this clinical experiment?
"Eligibility criteria for this trial include an age range of 18 to 85 and a diagnosis of renal failure. The recruitment quota is set at 48 participants."
Answered by AI
Is the study open to those below a certain age threshold?
"To be eligible for enrolment, patients must not have surpassed the age of 85 and should have reached 18 years of maturity."
Answered by AI
Are new participants being welcomed for this research endeavor?
"Per clinicaltrials.gov, this trial is no longer seeking new patients – it was initially revealed on March 16th 2023 and last modified on the tenth of that month. Although this particular experiment has ceased recruiting subjects currently, there are 166 other studies searching for volunteers to participate in trials at the moment."
Answered by AI
Has the Food and Drug Administration certified LY3473329 (Control) for medical use?
"Due to the limited clinical data for LY3473329 (Control), our team at Power places its safety on a scale of 1-3 with a score of 1. This is in keeping with it being a Phase 1 trial, where efficacy and safety have not been extensively evaluated."
Answered by AI
In what geographic locations is this research trial operating?
"Four clinical trials sites are in operation for this trial: Advanced Pharma Clinical Research (Miami), Orlando Clinical Research Center (Orlando), and Alliance for Multispecialty Research, LLC (Knoxville)."
Answered by AI
Who else is applying?
What site did they apply to?
Orlando Clinical Research Center
Advanced Pharma CR, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
Healthy guy, needs extra money.
PatientReceived 2+ prior treatments
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