Renal InsufficiencyPhase 1NCT05936138

A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment.

A Phase 1 study testing LY3502970 in people with Renal Insufficiency and Healthy, run by Eli Lilly and Company at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study is to assess the amount of study drug (LY3502970) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Renal Insufficiency, Healthy
What is being tested?: LY3502970
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 4 sitesUnited States
Study dates: 13 Jul 2023to 11 Apr 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Have a body mass index within the range 18.5 to 42.0 kilograms per meter squared (kg/m²), inclusive.
Men and women who agree to use highly effective or effective methods of contraception may participate in this trial.
Participants with Normal Renal Function:
Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function. Have estimated glomerular filtration rate (eGFR) of greater than or equal to 90 milliliter per minute (mL/min)
Participants with Renal Impairment:
Severe renal impairment: Have eGFR of 15 to 29 mL/min and not requiring hemodialysis.
ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing.

Who cannot join

Have a current, functioning organ transplant. Non-functional renal allografts may be allowed.
Regularly use known drugs of abuse or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications.
Have known allergies to LY3502970, related compounds, or any components of the formulation, or history of severe atopy.
Are lactating, pregnant, or intend to become pregnant, or to breastfeed during the study.
Have a history or presence of chronic or acute pancreatitis
Participants with Renal Impairment:
Have hemoglobin <8.5 g/dL.
Participants with Type 2 Diabetes Mellitus if they have taken any Glucagon-like Peptide-1 Receptor Agonists (GLP1-RA) or a Dipeptidyl Peptidase 4 (DPP4) inhibitor in the past 6 weeks or 5 half-lives prior to dosing, whichever is longer, prior to dosing on Day 1

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Alliance For multispecialty Research, LLC
Knoxville, Tennessee, 37920
Clinical Pharmacology of Miami
Miami, Florida, 33014
Advanced Pharma CR, LLC
Miami, Florida, 33147
Orlando Clinical Research Center
Orlando, Florida, 32809

Other trials in United States

About this study

Official title: A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment

Conditions: Renal Insufficiency, Healthy
Being tested: LY3502970
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3502970Drug
Administered orally.

Study groups in NCT05936138
Study group	Role	What they receive
LY3502970 (Normal Renal Function)	Experimental	A single oral dose of 1 milligram (mg) LY3502970 was administered to participants with normal renal function [defined as an estimated glomerular filtration rate (eGFR: ≥ 90 milliliters per minute (mL/min), and without a diagnosis of type 2 diabetes mellitus (T2D)] on day 1. Receives: Drug: LY3502970
LY3502970 (Severe Renal Impairment)	Experimental	A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function [defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D] on day 1. Receives: Drug: LY3502970
LY3502970 (End-Stage Renal Disease)	Experimental	A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease [defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D] on day 1. Receives: Drug: LY3502970

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY3502970
PK: (AUC0-∞) of LY3502970 is reported.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970
PK: AUC0-tlast of LY3502970 is reported.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose
PK: Maximum Observed Concentration (Cmax) of LY3502970
PK: Cmax of LY3502970 is reported.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 202311 Apr 2024

First posted7 Jul 2023
Study start13 Jul 2023
Primary completion11 Apr 2024
Study completion11 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05936138
Sponsor's protocol ID: 18633
Other IDs: J2A-MC-GZPC
Status last verified: Jun 2026
First submitted: 30 Jun 2023
Last updated: 9 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment
ClinicalTrials.gov ID: NCT05936138
Acronym / sponsor ID: 18633
Conditions: Renal Insufficiency, Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 13 Jul 2023 (actual)
Primary completion: 11 Apr 2024 (actual)
Study completion: 11 Apr 2024 (actual)
First posted: 7 Jul 2023 (actual)
Results: Posted 9 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
LY3502970 (Normal Renal Function)	Experimental	Drug: LY3502970A single oral dose of 1 milligram (mg) LY3502970 was administered to participants with normal renal function [defined as an estimated glomerular filtration rate (eGFR: ≥ 90 milliliters per minute (mL/min), and without a diagnosis of type 2 diabetes mellitus (T2D)] on day 1.
LY3502970 (Severe Renal Impairment)	Experimental	Drug: LY3502970A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function [defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D] on day 1.
LY3502970 (End-Stage Renal Disease)	Experimental	Drug: LY3502970A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease [defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D] on day 1.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Have a body mass index within the range 18.5 to 42.0 kilograms per meter squared (kg/m²), inclusive.
Men and women who agree to use highly effective or effective methods of contraception may participate in this trial.
Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function. Have estimated glomerular filtration rate (eGFR) of greater than or equal to 90 milliliter per minute (mL/min)
Severe renal impairment: Have eGFR of 15 to 29 mL/min and not requiring hemodialysis.
ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing.

Key exclusion criteria (8 listed)

Have a current, functioning organ transplant. Non-functional renal allografts may be allowed.
Regularly use known drugs of abuse or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications.
Have known allergies to LY3502970, related compounds, or any components of the formulation, or history of severe atopy.
Are lactating, pregnant, or intend to become pregnant, or to breastfeed during the study.
Have a history or presence of chronic or acute pancreatitis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3502970Administered orally.	Drug	LY3502970 (End-Stage Renal Disease), LY3502970 (Normal Renal Function), LY3502970 (Severe Renal Impairment)

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY3502970
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose
PK: (AUC0-∞) of LY3502970 is reported.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose
PK: AUC0-tlast of LY3502970 is reported.
PK: Maximum Observed Concentration (Cmax) of LY3502970
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose
PK: Cmax of LY3502970 is reported.

Results and safety

Results posted to the registry on 9 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY3502970 (Normal Renal Function)	10	9
LY3502970 (Severe Renal Impairment)	6	6
LY3502970 (End-Stage Renal Disease)	8	7

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY3502970

Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	LY3502970 (Normal Renal Function) n = 9	LY3502970 (Severe Renal Impairment) n = 5	LY3502970 (End-Stage Renal Disease) n = 7
Value	113 (32.1)	167 (48.6)	108 (87.8)

Population analysed: All enrolled participants who received at least one dose of study drug and have evaluable PK data.

Primary outcome: PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970

Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	LY3502970 (Normal Renal Function) n = 9	LY3502970 (Severe Renal Impairment) n = 5	LY3502970 (End-Stage Renal Disease) n = 7
Value	98.9 (32.9)	120 (48.9)	90.2 (79.7)

Population analysed: All enrolled participants who received at least one dose of study drug and have evaluable PK data.

Primary outcome: PK: Maximum Observed Concentration (Cmax) of LY3502970

Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per millilitre (ng/mL)

Measure	LY3502970 (Normal Renal Function) n = 9	LY3502970 (Severe Renal Impairment) n = 5	LY3502970 (End-Stage Renal Disease) n = 7
Value	5.01 (20.7)	6.01 (54.9)	4.29 (67.3)

Population analysed: All enrolled participants who received at least one dose of study drug and have evaluable PK data.

Adverse events

Time frame: Baseline through follow-up (Up to 12 Days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY3502970 (Normal Renal Function)	0 of 10 (0%)	0 of 10 (0%)	0 of 10
LY3502970 (Severe Renal Impairment)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
LY3502970 (End-Stage Renal Disease)	0 of 8 (0%)	6 of 8 (75%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3502970 in people with Renal Insufficiency and Healthy, run by Eli Lilly and Company at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY3502970 (time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05936138.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.