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Идёт набор NCT07411560

A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or Obese

Фаза I С лечением Overweight Obese

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: Glucose-dependent Insulinotropic Polypeptide (GIP), Cagrilintide, Placebo GIP.
Кому может быть актуально
Состояния в реестре: Overweight, Obese. Базовые параметры: 18 лет — 64 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

Single-centre Study Investigating the Role of Long-acting Subcutaneous Glucose-dependent Insulinotropic Polypeptide Receptor Agonist (GIP RA) in Combination With Long-acting Subcutaneous Amylin Receptor Agonist on Gastrointestinal Tolerability in Participants With Overweight or Obesity

Обзор

This trial is being done to look at the safety and effect of combining cagrilintide and NNC0480-0389 in people living with overweight and obesity compared to taking cagrilintide alone. In one period participants will get two medicines: cagrilintide and NNC0480-0389. In the other period, participants will get cagrilintide together with a placebo version of NNC0480-0389.The placebo looks like the real treatment but does not have any active medicine in it. Cagrilintide and NNC0480-0389 is a new medicine being tested to help people with type 2 diabetes and/or overweight or obesity. The trial medicines is not yet approved for use outside of clinical trials. Participants will receive the trial medicines the way the trial doctor has described. The study will last for about 4.5 months.

Вмешательства

  • Препарат Glucose-dependent Insulinotropic Polypeptide (GIP)
    Participants will receive GIP subcutaneously.
  • Препарат Cagrilintide
    Participants will receive Cagrilintide subcutaneously.
  • Препарат Placebo GIP
    Participants will receive placebo matched to GIP subcutaneously.

Первичные конечные точки

  • Number of Treatment Emergent Adverse Events (TEAEs) nausea, vomiting and diarrhoea [Срок оценки: From first investigational medicinal products (IMP) administration (visit 2, day 1 or visit 9, day 74) to the end of treatment visit (Visit 2, day 16 or Visit 9, day 89)]
Вторичные конечные точки (1)
  • Total number of Adverse Events [Срок оценки: First IMP administration (visit 2, day 1) to the end of treatment follow up visit (visit 16, day 142)]

Критерии участия

Критерии включения

  • Female at birth.
  • Age 18-64 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (BMI) between 27.0 kilograms per square meter (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening.
  • Overweight should be due to excess adipose tissue, as judged by the investigator.
  • Considered eligible with suitable veins for cannulation or repeated venepuncture, as judged by the investigator.
  • No clinically significant findings during medical history, physical examination, vital signs, electrocardiogram or clinical laboratory tests at the screening visit, as assessed by the investigator.

Критерии исключения

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
  • Current participation (i.e., dosing) in any other interventional clinical study within 90 days before screening.
  • Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
  • Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening, including incretin-based treatment(s).
  • Previous or planned (during the study period) obesity treatment with surgery. However, the following are allowed:
  • Liposuction and/or abdominoplasty, if performed greater than symbol (>) 1 year before screening.
  • Adjustable gastric banding, if the band has been removed > 1 year before screening.
  • Intragastric balloon, if the balloon has been removed > 1 year before screening.
  • Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed > 1 year before screening.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Великобритания · 1 центр
  • Parexel Research Unit — Harrow

Идентификаторы

NCT: NCT07411560 · EX0700-8445 · U1111-1324-3573

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗