Идёт набор NCT07401862

A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.

Фаза I С лечением Hepatic Insufficiency

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: LY3841136.
Кому может быть актуально: Состояния в реестре: Hepatic Insufficiency. Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Венгрия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Phase 1, Multicenter, Open-Label, Parallel-Design Study to Assess the Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Eloralintide (LY3841136) in Participants With Mild, Moderate, or Severe Hepatic Impairment and Participants With Normal Hepatic Function

Обзор

The main purpose of this study is to evaluate how a medicine, LY3841136, works in participants with different levels of liver damage and in participants with healthy liver. The researchers want to see how the medicine is absorbed and used by the body, and if it causes any side effects, in participants with mild, moderate, or severe liver damage, as well as in participants with normal liver function. For each participant, the study will last about 14 weeks, which will include a stay at the clinical research unit for 5 nights.

Вмешательства

Препарат LY3841136
Administered SC

Первичные конечные точки

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3841136 [Срок оценки: Predose on Day 1 up to Day 71]
PK: Maximum Observed Drug Concentration (Cmax) of LY3841136 [Срок оценки: Predose on Day 1 up to Day 71]

Критерии участия

Критерии включения

Have a body weight of 55 kilograms (kg) or more and body mass index between 19.0 and 40.0 kilograms per square meter (kg/m²), inclusive

Group 1

Are healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening

Groups 2 through 4

Have hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment who are considered acceptable for participation in this study by the investigator. Participants must have a diagnosis of chronic hepatic impairment of greater than 6 months per physician diagnosis and standard-of-care practice, with no clinically significant changes in the opinion of the investigator within 15 days prior to screening

Participants with hepatic impairment may have stable baseline medical conditions for which neither the condition nor treatments received would negatively impact the health of the participant or study conduct

Критерии исключения

Have a history or presence of chronic or acute pancreatitis or elevation in serum amylase or lipase greater than 1.5 × upper limit of normal (ULN)
Are pregnant or intend to become pregnant or to breastfeed during the study

Group 1

Have liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 1.5 × ULN or total bilirubin (TBL) greater than 1.5 × ULN at screening
Have a current infection with hepatitis B virus (HBV), that is,

if hepatitis B surface antigen (HBsAg) is positive, the participant is excluded, or
if HBsAg is negative and anti-Hepatitis B core antibody (HBc) is positive, further testing for HBV deoxyribonucleic acid (DNA) is required, and

if the screening HBV DNA is positive, the participant is excluded
Have a current infection with hepatitis C virus (HCV), that is,

if anti-HCV is positive, a test for circulating HCV ribonucleic acid (RNA) is required, and
if HCV RNA test is positive, the participant is excluded

Groups 2, 3, and 4

Have presence of active portal shunt or transjugular intrahepatic portosystemic shunt
Require paracentesis more often than 2 times per month or are expected to require paracentesis during the study
Have evidence of spontaneous bacterial peritonitis within 6 months of screening
Have had variceal bleeding within 3 months of screening. If the participant has undergone a successful banding procedure, they may participate in the study providing at least 1 month has passed after the banding procedure at the time of screening
Show presence of hepatocellular carcinoma
Have hepatic encephalopathy of Grade 2 or higher
Have TBL greater than 15 milligrams per deciliter (mg/dL)
Have ALT greater than or equal to 6 × ULN

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да