A Study of LY3502970 in Participants With Impaired and Normal Liver Function

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05882032

Collaborator

(none)

Enrollment

Locations

Arms

12.5

Anticipated Duration (Months)

7.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Hepatic Insufficiency	Drug: LY3502970	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Jun 16, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3502970 (Mild Hepatic Impairment) LY3502970 administered orally.	Drug: LY3502970 Administered orally.
Experimental: LY3502970 (Moderate Hepatic Impairment) LY3502970 administered orally.	Drug: LY3502970 Administered orally.
Experimental: LY3502970 (Severe Hepatic Impairment) LY3502970 administered orally.	Drug: LY3502970 Administered orally.
Experimental: LY3502970 (Normal Hepatic Function) LY3502970 administered orally.	Drug: LY3502970 Administered orally.

Outcome Measures

Primary Outcome Measures

Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3502970 [Predose up to 96 hours postdose]
PK: AUC0-∞ of LY3502970
PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3502970 [Predose up to 96 hours postdose]
PK: AUC0-tlast of LY3502970
PK: Maximum observed concentration (Cmax) of LY3502970 [Predose up to 96 hours postdose]
PK: Cmax of LY3502970

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 30 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.
Have T2DM controlled with diet or exercise alone or on stable doses of anti-diabetic medications such as metformin or sulfonylureas, for at least 8 weeks prior to screening.
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 such as 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
Have any one of the following:
a marked baseline prolongation of QT/QTc interval as determined, for example, from a QTc interval greater than 480 ms
a history of additional risk factors for Torsades de Pointes for example, heart failure, hypokalemia, family history of Long QT Syndrome, or
use concomitant medications that prolong the QT/QTc interval.
Women who are pregnant, intend to become pregnant or are breastfeeding a child are not eligible to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology of Miami	Miami	Florida	United States	33014
2	Orlando Clinical Research Center	Orlando	Florida	United States	32809
3	American Research Corporation at Texas Liver Institute	San Antonio	Texas	United States	78215
4	Pinnacle Clinical Research	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Eli Lilly and Company

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