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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT05882032 (opens ClinicalTrials.gov in a new tab)Other id18624Other idJ2A-MC-GZPB

Overview

Status
Completed
Phase
Phase 1
Enrollment
29 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
13 Jun 2023
Primary completion
18 Nov 2024
Completion
18 Nov 2024
First posted
31 May 2023
Last update posted
27 May 2026
Conditions
Healthy · Hepatic Insufficiency

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 1

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

    NCT05882032

    13 Jun 2023 to 18 Nov 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LY3502970Drug

Arms4

  • Experimental

    1 mg LY3502970 (Control: Normal Hepatic Function)

    Participants with normal hepatic function received a single 1 milligram (mg) dose of LY3502970 administered orally on Day 1.

  • Experimental

    1 mg LY3502970 (Mild Hepatic Impairment)

    Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.

  • Experimental

    1 mg LY3502970 (Moderate Hepatic Impairment)

    Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.

  • Experimental

    1 mg LY3502970 (Severe Hepatic Impairment)

    Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of LY3502970

    Time frame · Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1

    Registry description

    PK: AUC (0-∞) of LY3502970.

  2. PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970

    Time frame · Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1

    Registry description

    PK: AUC0-tlast of LY3502970.

  3. PK: Maximum Observed Concentration (Cmax) of LY3502970

    Time frame · Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1

    Registry description

    PK: Cmax of LY3502970.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of LY3502970

GroupValue (nanogram *hour per milliliter (ng*h/mL))Spread
1 mg LY3502970 (Control: Normal Hepatic Function)13026.8
1 mg LY3502970 (Mild Hepatic Impairment)13260.2
1 mg LY3502970 (Moderate Hepatic Impairment)20932.6
1 mg LY3502970 (Severe Hepatic Impairment)61184.6
Primary outcomeGeometric mean· Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1

PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970

GroupValue (ng*h/mL)Spread
1 mg LY3502970 (Control: Normal Hepatic Function)10929.1
1 mg LY3502970 (Mild Hepatic Impairment)11264.0
1 mg LY3502970 (Moderate Hepatic Impairment)16932.7
1 mg LY3502970 (Severe Hepatic Impairment)38554.7
Primary outcomeGeometric mean· Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1

PK: Maximum Observed Concentration (Cmax) of LY3502970

GroupValue (nanograms per milliliter (ng/mL))Spread
1 mg LY3502970 (Control: Normal Hepatic Function)5.1021.0
1 mg LY3502970 (Mild Hepatic Impairment)5.4757.5
1 mg LY3502970 (Moderate Hepatic Impairment)6.1243.6
1 mg LY3502970 (Severe Hepatic Impairment)5.9536.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
1 mg LY3502970 (Control: Normal Hepatic Function)Participants with normal hepatic function received a single 1 mg dose of LY3502970 administered orally on Day 1.0 / 110 / 112 / 11
1 mg LY3502970 (Mild Hepatic Impairment)Participants with mild hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.0 / 60 / 61 / 6
1 mg LY3502970 (Moderate Hepatic Impairment)Participants with moderate hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.0 / 60 / 61 / 6
1 mg LY3502970 (Severe Hepatic Impairment)Participants with severe hepatic impairment received a single 1 mg dose of LY3502970 administered orally on Day 1.0 / 60 / 60 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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