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A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment
Led by Eli Lilly and Company · Updated on 2025-12-04
32
Participants Needed
3
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight 55 kg or more and BMI between 19.0 and 40.0 kg/m2
- No significant history of spontaneous or ethanol-induced hypoglycemia
- Healthy participants with normal liver function confirmed by medical history and screening tests
- Normal blood pressure and pulse rate for healthy participants
- Participants with hepatic impairment classified as Child-Pugh score A, B, or C
- Chronic hepatic impairment diagnosis for more than 6 months with no significant recent changes
- Clinical lab results consistent with hepatic impairment or not clinically significant
- Serum glucose, lipids, triglycerides, urinary glucose, and protein abnormalities consistent with type 2 diabetes mellitus accepted
- Systolic blood pressure less than 150 mmHg, diastolic blood pressure less than 90 mmHg, pulse rate between 50 and 100 beats per minute
- Hemoglobin A1c equal to or less than 11.5% in participants with type 2 diabetes mellitus
You will not qualify if you...
- Significant history or current cardiovascular, respiratory, hepatic (for healthy group only), renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders that affect drug absorption, metabolism, elimination, or study risk
- History of severe or multiple allergic reactions, including allergies to LY3537031 or related compounds
- Prior bariatric surgery
- History or current acute or chronic pancreatitis or elevated serum lipase or amylase greater than 1.5 times upper limits of normal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Clinical Research Units Hungary
Kistarcsa, Hungary, H-243
Actively Recruiting
2
New Zealand Clinical Research Auckland
Auckland, New Zealand, 1010
Actively Recruiting
3
Summit Clinical Research, s.r.o. - Bratislava
Bratislava, Slovakia, 831 01
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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