Your session is about to expire
← Back to Search
Monoclonal Antibodies
LY3502970 for Kidney Failure
Phase 1
Recruiting
Research Sponsored by Eli Lilly and Company
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 12 days postdose
Awards & highlights
Study Summary
This trial tests how a drug (LY3502970) affects people with kidney impairment and those with healthy kidneys. Safety and tolerability will be checked over 6 weeks.
Who is the study for?
This trial is for adults with a BMI of 18.5-42 kg/m² who are either healthy or have kidney issues, including severe impairment or those on stable hemodialysis. Participants must use contraception and cannot be pregnant, breastfeeding, drug abusers, allergic to LY3502970, severely anemic, have organ transplants (except non-functional renal ones), or recently used certain diabetes medications.Check my eligibility
What is being tested?
The study tests how the body processes the drug LY3502970 in people with different levels of kidney function. It compares how much drug gets into the blood and how quickly it's eliminated between those with normal kidneys and those with impaired function over up to six weeks.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for safety and tolerability of LY3502970 which suggests watching for any adverse reactions such as discomforts or health changes that may occur after taking the medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose up to 12 days postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 12 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 LY3502970
PK: Maximum observed concentration (Cmax) of LY3502970
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3502970
Side effects data
From 2022 Phase 2 trial • 383 Patients • NCT0504871938%
Nausea
21%
Vomiting
16%
Diarrhoea
13%
Constipation
9%
Fatigue
9%
Lipase increased
9%
Covid-19
7%
Gastrooesophageal reflux disease
7%
Dyspepsia
5%
Abdominal distension
5%
Palpitations
5%
Decreased appetite
4%
Eructation
4%
Arthralgia
4%
Urticaria
4%
Weight decreased
4%
Headache
2%
Muscle spasms
2%
Dizziness
2%
Hypertension
2%
Abdominal pain upper
2%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
12 mg LY3502970
24 mg LY3502970
36 mg LY3502970 - 2
45 mg LY3502970 - 1
36 mg LY3502970 - 1
Placebo
3 mg LY3502970
45 mg LY3502970 - 2
1.5 mg Dulaglutide
Trial Design
3Treatment groups
Experimental Treatment
Group I: LY3502970 (Severe Renal Impairment)Experimental Treatment1 Intervention
LY3502970 administered orally to participants with severe renal impairment
Group II: LY3502970 (End-Stage Renal Disease)Experimental Treatment1 Intervention
LY3502970 administered orally to participants with end-stage renal disease (ESRD)
Group III: LY3502970 (Control)Experimental Treatment1 Intervention
LY3502970 administered orally to participants with normal renal function
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3502970
2021
Completed Phase 2
~1220
Find a Location
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
3,201,491 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,685 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe kidney issues but don’t need dialysis, or I've been on stable dialysis for 3+ months.I have a working organ transplant.I have had pancreatitis before or have it now.I do not use recreational drugs or have unexpected results on drug tests.I agree to use effective birth control during the trial.I have Type 2 Diabetes and haven't taken GLP1-RA or DPP4 inhibitors recently.My kidney function is normal, with an eGFR of 90 mL/min or higher.I have severe kidney issues but don't need dialysis, or I've been on stable dialysis for 3+ months.My hemoglobin level is below 8.5 g/dL due to kidney issues.
Research Study Groups:
This trial has the following groups:- Group 1: LY3502970 (Severe Renal Impairment)
- Group 2: LY3502970 (End-Stage Renal Disease)
- Group 3: LY3502970 (Control)
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.
To whom is this investigation open for enrollment?
"This study requires that its participants have end-stage renal disease and be aged between 18 - 85 years old. A total of 26 patients will take part in the trial."
Answered by AI
Are individuals below the age of fifty eligible for this medical trial?
"In order to partake in this research trial, patients must be aged between 18 and 85. For those who are younger or older than the specified age range, there are 61 studies for minors and 520 trials for senior citizens."
Answered by AI
Has the FDA sanctioned LY3502970 (Control) for use?
"According to our team at Power, the safety rating of LY3502970 (Control) is 1 due to its status as a Phase 1 trial. This suggests that there has been restricted data collected regarding both efficacy and safety."
Answered by AI
Is there availability in the current clinical trial for new participants?
"The data advertised on clinicaltrials.gov confirms that no fresh participants are being sought for this trial, which was initially posted on July 13th of 2023 and amended most recently on June 30th of the same year. Nevertheless, there are still 949 other studies looking to enroll volunteers at present."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What site did they apply to?
Alliance for Multispecialty Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger