- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05882032
A Study of LY3502970 in Participants With Impaired and Normal Liver Function
January 29, 2024 updated by: Eli Lilly and Company
A Phase 1, Multicenter, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment
The main purpose of this study is to measure how much of LY3502970 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to participants with normal liver function.
The safety and tolerability of LY3502970 will also be evaluated.
The study may last up to 6 weeks for each participant including the screening period.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
33
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Phone Number: 1-317-615-4559
- Email: clinicaltrials.gov@lilly.com
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33014
- Recruiting
- Clinical Pharmacology of Miami
-
Principal Investigator:
- Alexander Prezioso
-
Contact:
- Phone Number: 305-817-2900
-
Orlando, Florida, United States, 32809
- Recruiting
- Orlando Clinical Research Center
-
Contact:
- Phone Number: 407-240-7878
-
Principal Investigator:
- Thomas Marbury
-
-
Texas
-
San Antonio, Texas, United States, 78229
- Recruiting
- Pinnacle Clinical Research
-
Principal Investigator:
- Madhavi Rudraraju
-
Contact:
- Phone Number: 210-982-0320
-
San Antonio, Texas, United States, 78215
- Recruiting
- Texas Liver Institute
-
Contact:
- Phone Number: 210-253-3426
-
Principal Investigator:
- Eric Lawitz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Men or women with body weight of at least 45 kilograms and a body mass index of 18.5 to 40.0 kilograms per meter squared (kg/m²).
- Both healthy individuals and individuals with hepatic impairment classified as Child-Pugh Score A, B, C that is mild, moderate, or severe impairment, respectively, liver disease can participate who are considered acceptable for participation in this study by the investigator.
- Participants must have a diagnosis of chronic hepatic impairment for more than 6 months per physician diagnosis and standard of care practice, with no clinically significant changes within 15 days prior to study intervention administration.
- Participants may have mild stable baseline medical conditions for which neither the condition nor treatments received would negatively impact the health of the participant or study conduct.
- Have acceptable BP and pulse rate, as determined by the investigator at screening.
- No significant history of spontaneous or ethanol induced hypoglycemia.
- Participants with Mild to Severe Hepatic Impairment who have a hemoglobin level of at least 8.5 grams/deciliter.
- Participants with both T2DM and Hepatic Impairment have T2DM controlled with diet or exercise alone or on stable doses of anti-diabetic medications metformin or sulfonylureas, for at least 8 weeks prior to screening.
- Participants with both T2DM and Hepatic Impairment have a hemoglobin A1c greater than or equal to 5.0% and less than or equal to 11.0% at the screening visit.
- Participants with both T2DM and Hepatic Impairment have clinical laboratory test results within normal range or deemed clinically insignificant by the investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable.
Exclusion Criteria:
- Have significant history of, or current, cardiovascular, respiratory, hepatic (applies to Group 1 only), renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
- Have a history or presence of pancreatitis, elevation in serum amylase or lipase (greater than 1.5-fold ULN) or GI disorder or any GI disease, which impacts gastric emptying.
- Have any abnormality in the 12-lead ECG at screening.
- Have severe atopy or have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions.
- Have a history of, or current psychiatric disorders.
- Women who are pregnant, intend to become pregnant or are breastfeeding a child are not eligible to participate.
- Have taken any glucose-lowering medications other than metformin, sulfonylureas, and insulin, in the past 6 weeks or 5 half-lives (whichever is longer) prior to planned dosing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LY3502970 (Mild Hepatic Impairment)
LY3502970 administered orally.
|
Administered orally.
|
Experimental: LY3502970 (Moderate Hepatic Impairment)
LY3502970 administered orally.
|
Administered orally.
|
Experimental: LY3502970 (Severe Hepatic Impairment)
LY3502970 administered orally.
|
Administered orally.
|
Experimental: LY3502970 (Normal Hepatic Function)
LY3502970 administered orally.
|
Administered orally.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3502970
Time Frame: Predose up to 96 hours postdose
|
PK: AUC0-∞ of LY3502970
|
Predose up to 96 hours postdose
|
PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3502970
Time Frame: Predose up to 96 hours postdose
|
PK: AUC0-tlast of LY3502970
|
Predose up to 96 hours postdose
|
PK: Maximum observed concentration (Cmax) of LY3502970
Time Frame: Predose up to 96 hours postdose
|
PK: Cmax of LY3502970
|
Predose up to 96 hours postdose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2023
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
May 22, 2023
First Submitted That Met QC Criteria
May 22, 2023
First Posted (Actual)
May 31, 2023
Study Record Updates
Last Update Posted (Actual)
January 30, 2024
Last Update Submitted That Met QC Criteria
January 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18624
- J2A-MC-GZPB (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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