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Tests treatment safety and results for Healthy
Official title A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment
ClinicalTrials.gov ID: NCT07165002
What this study is testing
What is LY3537031?
LY3537031 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- 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 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...
- Have normal blood pressure (BP) and pulse rate, as determined by the investigator Additional for Participants with Mild to Severe Hepatic Impairment...
- Participants with hepatic impairment classified as Child-Pugh score A, B, or C who are considered acceptable for participation in this study by the...
You likely can't join if
- Have significant history of or current cardiovascular, respiratory, hepatic (hepatic applies to Group 1 only), renal, gastrointestinal (GI)...
- Have a history of atopy; that is, severe or multiple allergic manifestations, or clinically significant multiple or severe drug allergies, or...
- 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...
See the full eligibility 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 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 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...
- 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...
- 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
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Kistarcsa, Hungary
- Auckland, New Zealand
- Bratislava, Slovakia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kistarcsa, Hungary; Auckland, New Zealand; Bratislava, Slovakia. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.