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Renal InsufficiencyPhase 1NCT07137689

A Study of LY3537982 in Participants With Kidney Problems Compared With Participants With Normal Kidney Function

A Phase 1 study testing LY3537982 in people with Renal Insufficiency, 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 purpose of this study is to help determine the right dose of LY3537982 in participants with kidney problems, particularly those with severe kidney problems. The study will last about 43 days for each participant. 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
What is being tested?
LY3537982
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
4 sitesUnited States
Study dates
18 Aug 2025to 10 Apr 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 (BMI) within the range 19.0 to 42.0 kilograms per square meter (kg/m²), inclusive.
  • Participants Assigned Male at Birth (AMAB) who agree to follow contraception guidance or participants AFAB who are individuals of childbearing potential (INOCBP).
  • Severe renal impairment: Have eGFR determined by CKD-EPI of less than 30 mL/min and not requiring dialysis.
  • Moderate renal impairment: Have eGFR determined by CKD-EPI of greater than or equal to 30 mL/min and less than 60 mL/min.
  • Are not currently or have not previously been on hemodialysis, including peritoneal dialysis.
  • Have acceptable blood pressure as defined by systolic blood pressure less than 160 mmHg and diastolic blood pressure less than 95 mmHg, as well as acceptable pulse rate as defined by no less than 50 bpm and no greater than 100 bpm

Who cannot join

  • Have history of chronic liver disease, or any evidence for hepatic impairments, or
  • ALT or AST greater than 2.5 × ULN without any increase in TBL or * TBL greater than 1.5 × ULN without any increase in aminotransferase.
  • Have a current, functional renal transplant. Non-functional renal allografts may be allowed if failure has been greater than 1 year and no longer on immunosuppressive therapies.
  • Diagnosed and/or treated malignancy within 5 years prior to screening with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and curatively resected in situ carcinoma of the cervix
  • Have known allergies to LY3537982, related compounds or any components of the formulation, or a history of significant atopy.
  • Have previously completed or withdrawn from this study or any other study investigating LY3537982.
Show all 11Show fewer
  • Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days, whichever is longer should have passed, prior to admission
  • Show evidence of HIV infection or positive human HIV antibodies.
  • Have evidence of hepatitis B at screening, that is, positive test for hepatitis B surface antigen, HBV DNA, or both.
  • Have a positive hepatitis C antibody test. Participants with a positive hepatitis C antibody test at screening can be included only if a confirmatory HCV RNA test is negative.
  • Are participants AFAB with a positive pregnancy test or who are lactating. ssion onward, up to 2 g per day of acetaminophen will be allowed at the discretion of the investigator.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Orlando Clinical Research Center

    Orlando, Florida, 32809

  • Genesis Clinical Research

    Tampa, Florida, 33603

Other trials in United States

About this study

Official title: Pharmacokinetics of LY3537982 Following a Single Dose in Participants With Renal Impairment Compared With Participants With Normal Renal Function

The purpose of this study is to help determine the right dose of LY3537982 in participants with kidney problems, particularly those with severe kidney problems. The study will last about 43 days for each participant.

Being tested
LY3537982
Medical subject headings
Renal Insufficiency

What participants receive

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

  • LY3537982Drug

    Administered orally

Study groups in NCT07137689
Study groupRoleWhat they receive
LY3537982 (Normal renal function)ExperimentalLY3537982 administered orally.
Receives: Drug: LY3537982
LY3537982 (Severe renal impairment)ExperimentalLY3537982 administered orally.
Receives: Drug: LY3537982
LY3537982 (Moderate renal impairment)ExperimentalLY3537982 administered orally.
Receives: Drug: LY3537982

What is being measured

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

  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY3537982

    Measured: Day 1, Predose up to Day 5 Postdose

  2. Pharmacokinetics: Area Under the Concentration Verses Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3537982

    Measured: Day 1, Predose up to Day 5 Postdose

  3. Pharmacokinetics: Area Under the Concentrations Verses Time Curve from Time Zero to Time t (AUC(0-tlast) of LY3537982

    Measured: Day 1, Predose up to Day 5 Postdose

Timeline

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

  1. First posted22 Aug 2025
  2. Study start18 Aug 2025
  3. Primary completion10 Apr 2026
  4. Study completion10 Apr 2026

Resources

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07137689
Sponsor's protocol ID
18678
Other IDs
J3M-OX-JZQG
Status last verified
Apr 2026
First submitted
17 Aug 2025
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3537982 in people with Renal Insufficiency, 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 6 inclusion and 11 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 23 Apr 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: Maximum Concentration (Cmax) of LY3537982 (time frame: Day 1, Predose up to Day 5 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 NCT07137689.

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 23 Apr 2026.

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