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Идёт набор NCT07693231

A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Japanese Healthy People and Japanese People With Obesity or Overweight

Фаза I С лечением Healthy Obesity

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: BI 3034701, Placebo.
Кому может быть актуально
Состояния в реестре: Healthy, Obesity. Базовые параметры: 18 лет — 64 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
Япония
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase I, Single-blinded, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 3034701 in Japanese Male and Female Participants With Obesity/Overweight and Otherwise Healthy (Part 1) and Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 3034701 in Japanese Male and Female Healthy Volunteers (Part 2)

Обзор

Part 1: To investigate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 3034701 in Japanese male and female participants with body mass index (BMI) ≥27.0 kg/m² or more following subcutaneous administration of multiple rising doses over 16 weeks. Part 2: To investigate safety, tolerability, and PK of BI 3034701 in Japanese male and female healthy participants with BMI ≥23.0 to \<27.0 kg/m² following subcutaneous administration of multiple rising doses over 7 weeks.

Вмешательства

  • Препарат BI 3034701
    BI 3034701
  • Препарат Placebo
    Placebo

Первичные конечные точки

  • Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator [Срок оценки: Part 1: up to Week 19, Part 2: up to Week 10]
Вторичные конечные точки (3)
  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) following a single dose and multiple doses of BI 3034701 [Срок оценки: Part 1: up to Week 17, Part 2: up to Week 8]
  • Maximum measured concentration of the analyte in plasma (Cmax) following a single dose and multiple doses of BI 3034701 [Срок оценки: Part 1: up to Week 19, Part 2: up to Week 10]
  • Change from baseline in body weight at the end of 16 weeks treatment (only evaluated for Part 1) [Срок оценки: Part 1: at Baseline and at Week 16]

Критерии участия

Критерии включения

  • Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan < 10 years, and have parents and grandparents who are Japanese
  • Part 1: Male or female trial participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
  • Part 2: Healthy male or female trial participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
  • Parts 1 and 2: Age of 18 to 64 years (inclusive)
  • Further inclusion criteria apply.

Критерии исключения

  • Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and, in particular: alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20%, aspartate aminotransferase (AST) above ULN + 20%, gamma-glutamyl transferase (GGT) above ULN + 20%, Lipase or amylase above ULN + 20%, bilirubin above 1.2x ULN (except for cases of Gilbert's Syndrome), estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m²
  • Part 1: Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screening
  • Further exclusion criteria apply.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Япония · 3 центра
  • SOUSEIKAI Hakata Clinic — Fukuoka, Fukuoka
  • Fukuoka Mirai Hospital — Fukuoka, Fukuoka
  • SOUSEIKAI Sumida Hospital — Tokyo, Sumida-ku

Идентификаторы

NCT: NCT07693231 · 1507-0004 · U1111-1334-2043

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗