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Идёт набор NCT07437079

A Study to See How Safe a New Medicine (NNC6989-0001) is in Healthy People Living With Overweight or Obesity

Фаза I С лечением Overweight 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: NNC6989-0001, Placebo (NNC6989-0001).
Кому может быть актуально
Состояния в реестре: Overweight, Obesity. Базовые параметры: 18 лет — 55 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
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 First Human Dose Study Investigating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Single and Multiple Ascending Doses of NNC6989-0001 in Healthy Participants With Overweight or Obesity

Обзор

This study is testing a new medicine, NNC6989-0001, to test it is safe and tolerable for healthy people living with overweight or obesity. NNC6989-0001 is still being tested in studies and is not yet available for prescription by doctors. In this study, participants will receive either NNC6989-0001 or a placebo; which treatment each participant receives will be decided by chance.

Вмешательства

  • Препарат NNC6989-0001
    Participants assigned to the active intervention receive NNC6989-0001
  • Препарат Placebo (NNC6989-0001)
    Participants assigned to the placebo, receive placebo matched in appearance to the active drug.

Первичные конечные точки

  • Number of treatment emergent adverse events (TEAE) - Part A [Срок оценки: From time of dosing on Day1 until completion of the end of study visit (Day 7)]
  • Number of treatment emergent adverse events (TEAE) - Part B [Срок оценки: From time of dosing on Day 1 until completion of the end of study visit (Day 14)]
  • iAUCTG; The incremental area under the blood triglycerides concentration-time curve following meal test - Part C [Срок оценки: Following meal test at Day -1, Day 1, Day 7 and Day 13]
Вторичные конечные точки (6)
  • AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part A [Срок оценки: From pre-dose on Day 1 until completion of the end of study visit (Day 7)]
  • Cmax; the maximum plasma concentration of NNC6989-0001 - Part A [Срок оценки: From pre-dose on Day 1 until completion of the end of study visit (Day 7)]
  • AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part B [Срок оценки: From pre-dose on Day 1 until completion of the end of study visit (Day 14)]
  • Cmax; the maximum plasma concentration of NNC6989-0001 - Part B [Срок оценки: From pre-dose on Day 1 until completion of the end of study visit (Day 14)]
  • AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part C [Срок оценки: From pre-dose on Day 1 until completion of the end of study visit (Day 20)]
  • Cmax; the maximum plasma concentration of NNC6989-0001 - Part C [Срок оценки: From pre-dose on Day 1 until completion of the end of study visit (Day 20)]

Критерии участия

Критерии включения

  • Male or female of non-childbearing potential.
  • Age 18-55 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (BMI) (at screening) ≥ 25.0 and ≤ 34.9 kg/m\^2 for Part A (SAD part) and BMI (at screening) ≥ 25.0 and ≤ 39.9 kg/m\^2 for Part B (MAD part) and Part C (meal timing and potentially meal composition).
  • Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Критерии исключения

  • Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
  • Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before screening
  • Use of prescription or non-prescription medicinal products within 14 days before screening. This includes over the counter medicines such as laxatives, mineral oil, and fat-blocking supplements. Routine multivitamin/mineral supplements at labelled daily doses are permitted; other non-prescription supplements (e.g., high-dose vitamins, weight-loss supplements) are not permitted. Occasional use of over-the-counter acetaminophen or NSAIDs at their labelled doses for mild pain is permitted.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • ICON Early Phase Services, LLC — Lenexa

Идентификаторы

NCT: NCT07437079 · NN6989-8611 · U1111-1326-7700

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗