Идёт набор NCT07395687

A Research Study on How Well Different Doses of the Medicine UBT251 Help People Living With Overweight or Obesity

Фаза II 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: UBT251, Placebo.
Кому может быть актуально: Состояния в реестре: Overweight, Obesity. Базовые параметры: 18 лет — 65 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, Канада
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 Study Investigating Safety, Tolerability and Efficacy of UBT251 in Participants Living With Overweight or Obesity

Обзор

The purpose of this clinical study is to find out if UBT251 is safe and effective for treating people who are living with overweight or obesity. Participants will get either UBT251 (the treatment being tested) or Placebo (a treatment that has no active medicine in it), which treatment participants get is decided by chance.

Вмешательства

Препарат UBT251
UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.
Препарат Placebo
Placebo matched to UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin.

Первичные конечные точки

Part A - Number of treatment emergent adverse events (TEAEs) [Срок оценки: From baseline (week 0) to end of study (week 33)]
Part B - Relative change in body weight [Срок оценки: From baseline (week 0) to end of treatment (week 28)]
Part C- AUC; the area under the UBT251 plasma concentration time curve [Срок оценки: From pre-dose on Day 1 until completion of the end of study visit (Day 43)]

Вторичные конечные точки (9)

Part A - Relative change in body weight [Срок оценки: From baseline (week 0) to end of treatment (week 28)]
Part A - Change in body weight [Срок оценки: From baseline (week 0) to end of treatment (week 28)]
Part A - AUC; the area under the UBT251 plasma concentration-time curve [Срок оценки: From pre-dose on day 1 to end of study (week 33)]
Part A - Cmax; the maximum plasma concentration of UBT251 [Срок оценки: From pre-dose on day 1 to end of study (week 33)]
Part B - Change in body weight [Срок оценки: From baseline (week 0) to end of treatment (week 28)]
Part B - Change in waist circumference [Срок оценки: From baseline (week 0) to end of treatment (week 28)]
Part B - Number of TEAEs [Срок оценки: From baseline (week 0) to end of study (week 33)]
Part C - Cmax; the maximum plasma concentration of UBT251 [Срок оценки: From pre-dose on Day 1 until completion of the end of study visit (Day 43)]
Part C - Number of treatment-emergent adverse events (TEAEs) [Срок оценки: From pre-dose on Day 1 until completion of the end of study visit (Day 43)]

Критерии участия

Критерии включения

Male or female (sex at birth).
For Part C: Japanese, Chinese or non-Asian participants (all self-reported):

For Japanese participants: both parents of Japanese descent.
For Chinese participants: both parents of Chinese descent.
For non-Asian participants: both parents of non-Asian descent (non-Asian is defined as of countries outside of Asia).
Age at the time of signing the informed consent:

For Part A: 18-55 years (both inclusive)
For Part B: 18-65 years (both inclusive)
For Part C: 18-55 years (both inclusive).
BMI at screening (overweight and obesity should be due to excess adipose tissue, as judged by the investigator):

For Part A: 27.0-39.9 kilogram per meter square (kg/m\^2) (both inclusive)
For Part B: 30.0-50.0 kg/m\^2 (both inclusive)
For Part C: 24-34.9 kg/m\^2 (both inclusive)
Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Критерии исключения

Known or suspected hypersensitivity to study intervention(s) or related products.
Treatment with any marketed product containing compounds with glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) or glucagon receptor agonism within 90 days before screening.
Any condition, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.

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

Здоровые добровольцы: Нет