Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07165002




Registration number
NCT07165002
Ethics application status
Date submitted
3/09/2025
Date registered
10/09/2025
Date last updated
10/09/2025

Titles & IDs
Public title
A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment
Scientific 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
Secondary ID [1] 0 0
J2S-MC-GZML
Secondary ID [2] 0 0
27392
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Hepatic Insufficiency 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3537031

Experimental: LY3537031 (Group 1) - Administered subcutaneously (SC) in participants with normal hepatic function

Experimental: LY3537031 (Group 2) - Administered SC in participants with mild hepatic impairment

Experimental: LY3537031 (Group 3) - Administered SC in participants with moderate hepatic impairment

Experimental: LY3537031 (Group 4) - Administered SC in participants with severe hepatic impairment


Treatment: Drugs: LY3537031
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031
Timepoint [1] 0 0
Baseline to Study Completion (Up to 8 Weeks)
Primary outcome [2] 0 0
PK: Maximum Concentration (Cmax) of LY3537031
Timepoint [2] 0 0
Baseline to Study Completion (Up to 8 Weeks)

Eligibility
Key inclusion criteria
* 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:

* 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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)

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Hungary
State/province [1] 0 0
Kistarcsa
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
Slovakia
State/province [3] 0 0
Bratislava

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07165002