Идёт набор NCT07595549

A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity

Фаза III С лечением Obesity Overweight and/or Obesity Overweight

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: PF-08653944, Placebo.
Кому может быть актуально: Состояния в реестре: Obesity, Overweight and/or Obesity, Overweight. Базовые параметры: от 18 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, 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 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF-08653944 IN ADULTS WITH OVERWEIGHT OR OBESITY (VESPER-6)

Обзор

The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes. About 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe. People will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.

Вмешательства

Препарат PF-08653944
By Subcutaneous Injection
Другое Placebo
By Subcutaneous Injection

Первичные конечные точки

Percent change from baseline in body weight [Срок оценки: Baseline, Week 72]

Вторичные конечные точки (12)

Change from baseline in body weight [Срок оценки: Baseline, Week 72]
Change from baseline in waist circumference [Срок оценки: Baseline, Week 72]
Percentage of Participants achieving ≥5% of body weight reduction from baseline [Срок оценки: Baseline, Week 72]
Percentage of Participants achieving ≥10% of body weight reduction from baseline [Срок оценки: Baseline, Week 72]
Percentage of Participants achieving ≥15% of body weight reduction from baseline [Срок оценки: Baseline, Week 72]
Percentage of Participants achieving ≥20% of body weight reduction from baseline [Срок оценки: Baseline, Week 72]
Percentage of Participants with a waist-to-height ratio of <0.53 [Срок оценки: Baseline, Week 72]
Percent change from baseline in body weight in participants with type 2 diabetes [Срок оценки: Baseline, Week 72]
Change from baseline in Systolic Blood Pressure (SBP) [Срок оценки: Baseline, Week 72]
Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score [Срок оценки: Baseline, Week 72]
Percentage of Participants achieving ≥25% of body weight reduction from baseline [Срок оценки: Baseline, Week 72]
Change from baseline in Diastolic Blood Pressure (DBP) [Срок оценки: Baseline, Week 72]

Критерии участия

Критерии включения

Aged ≥18 years.
BMI of: ≥30 kg/m2 or ≥27.0 kg/m2 to <30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.

Критерии исключения

Have a self-reported body weight change greater than 5% within 90 days prior to Screening.
Diagnosis of type 1 diabetes or any other form of diabetes other than T2D.
History of acute or chronic pancreatitis.
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).

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

Здоровые добровольцы: Нет