HealthyPhase 1NCT07165002
A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment
A Phase 1 study testing LY3537031 in people with Healthy and Hepatic Insufficiency, run by Eli Lilly and Company at 3 sites in 3 countries.
Trial summary
The purpose of this study is to measure how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function and in healthy participants with normal liver function. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hepatic Insufficiency
- What is being tested?
- LY3537031
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 20 Oct 2025to Nov 2026
- Phase
- Phase 1
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 weight of 55 kilogram (kg) or more and body mass index (BMI) between 19.0 and 40.0 kilogram per square meter (kg/m²), inclusive
- Have no significant history of spontaneous or ethanol-induced hypoglycemia
- Additional Inclusion Criteria for Participants Without Hepatic Impairment in Group 1:
- Are healthy participants as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening
- Have normal blood pressure (BP) and pulse rate, as determined by the investigator
- Additional Inclusion Criteria for Participants with Mild to Severe Hepatic Impairment in Groups 2 through 4:
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- Participants with hepatic impairment classified as Child-Pugh score A, B, or C who are considered acceptable for participation in this study by the investigator. Participants must have a diagnosis of chronic hepatic impairment of greater than 6 months per physician diagnosis and standard-of-care practice, with no clinically significant changes, in the opinion of the investigator, within 15 days prior to screening
- Clinical laboratory test results with deviations that are judged by the investigator to be compatible with the hepatic impairment of the participant, or of no additional clinical significance for this study. Abnormalities of serum glucose, serum lipids and triglycerides, urinary glucose, and urinary protein consistent with Type 2 Diabetes Mellitus (T2DM) are acceptable
- Have a systolic BP less than 150 millimeters mercury (mmHg), a diastolic BP less than 90 mmHg, and a pulse rate greater than 50 but less than 100 beats per minute
- If participants have T2DM, they must have a hemoglobin A1c measurement equal to or less than 11.5% at the screening visit
Who cannot join
- Have significant history of or current cardiovascular, respiratory, hepatic (hepatic applies to Group 1 only), renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data
- Have a history of atopy; that is, severe or multiple allergic manifestations, or clinically significant multiple or severe drug allergies, or hyperesthesia, or severe posttreatment hypersensitivity reactions, or have known allergies to LY3537031, or related compounds
- Have undergone any form of bariatric surgery
- Have a history of or current acute or chronic pancreatitis, or elevation in serum lipase or amylase or both greater than 1.5× upper limits of normal (ULN)
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
3 sites in 3 countries
Hungary1 site, 1 recruiting
- Recruiting
Clinical Research Units Hungary
Kistarcsa, H-243
+36 28 999 640
Geza Lakner
New Zealand1 site, 1 recruiting
- Recruiting
New Zealand Clinical Research Auckland
Auckland, 1010
0800 788 3437
Edward Gane
Slovakia1 site, 1 recruiting
- Recruiting
Summit Clinical Research, s.r.o. - Bratislava
Bratislava, 831 01
00 421 908 729 723
Viera Kupčova
About this study
Official title: A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment
The purpose of this study is to measure how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function and in healthy participants with normal liver function. The safety and tolerability of LY3537031 will also be evaluated. The study drug will be administered subcutaneously (SC) (under the skin).
- Conditions
- Healthy, Hepatic Insufficiency
- Being tested
- LY3537031
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3537031Drug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3537031 (Group 1) | Experimental | Administered subcutaneously (SC) in participants with normal hepatic function Receives: Drug: LY3537031 |
| LY3537031 (Group 2) | Experimental | Administered SC in participants with mild hepatic impairment Receives: Drug: LY3537031 |
| LY3537031 (Group 3) | Experimental | Administered SC in participants with moderate hepatic impairment Receives: Drug: LY3537031 |
| LY3537031 (Group 4) | Experimental | Administered SC in participants with severe hepatic impairment Receives: Drug: LY3537031 |
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 (AUC) of LY3537031
PK: AUC of LY3537031
Measured: Baseline to Study Completion (Up to 8 Weeks)
PK: Maximum Concentration (Cmax) of LY3537031
PK: Cmax of LY3537031
Measured: Baseline to Study Completion (Up to 8 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start20 Oct 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165002
- Sponsor's protocol ID
- 27392
- Other IDs
- J2S-MC-GZML
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No