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Monoclonal Antibodies

LY3502970 for Kidney Failure

Phase 1
Waitlist Available
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 weeks
Treatment ~ Varies
Follow Up ~predose up to 12 days postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 12 days postdose for reporting.

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 • NCT05048719
37%
Nausea
33%
Vomiting
26%
Diarrhoea
22%
Constipation
19%
Eructation
11%
Weight decreased
11%
Dyspepsia
11%
Flatulence
7%
Asthenia
7%
Urticaria
7%
Abdominal pain upper
7%
Abdominal distension
7%
Retching
7%
Decreased appetite
7%
Haemoglobin decreased
4%
Ischaemic stroke
4%
Fatigue
4%
Lipase increased
4%
Arthralgia
4%
Hypertension
4%
Palpitations
100%
80%
60%
40%
20%
0%
Study treatment Arm
36 mg LY3502970 - 1
45 mg LY3502970 - 1
12 mg LY3502970
24 mg LY3502970
36 mg LY3502970 - 2
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
~1240

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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
2,624 Previous Clinical Trials
3,216,897 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
415,656 Total Patients Enrolled

Media Library

LY3502970 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05936138 — Phase 1
Kidney Failure Research Study Groups: LY3502970 (Severe Renal Impairment), LY3502970 (End-Stage Renal Disease), LY3502970 (Control)
Kidney Failure Clinical Trial 2023: LY3502970 Highlights & Side Effects. Trial Name: NCT05936138 — Phase 1
LY3502970 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05936138 — Phase 1
~13 spots leftby May 2025
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