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

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

• Status: Recruiting
• Conditions: Hepatic Insufficiency; Healthy
• Intervention / Treatment: Drug: LY3502970

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Phase 1

Contacts and Locations

• 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

• United States
  • 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

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

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	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	PK: AUC0-tlast of LY3502970	Predose up to 96 hours postdose
PK: Maximum observed concentration (Cmax) of LY3502970	PK: Cmax of LY3502970	Predose up to 96 hours postdose

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

Helpful Links

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

Study record dates

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: LY3502970; Pharmacokinetics Hepatic Impairment; GLP-1 Receptor Non-peptide agonist (GLP-1 NPA)
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency
• 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