Идёт набор NCT07667803

A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM

Фаза III С лечением Weight Management

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: Elecoglipron, Placebo.
Кому может быть актуально: Состояния в реестре: Weight Management. 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, Аргентина, Австралия, Бразилия, Канада +14
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (Embold)

Обзор

This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).

Подробное описание

This is a Phase III, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 2 doses of elecoglipron compared with placebo, given once daily as oral tablets. This protocol covers two independent pivotal studies in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 25 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Prediabetes, Dyslipidemia, CV disease and/or Obstructive sleep apnea) without T2DM (Study 1) and as well as those who are living with obesity or overweight with T2DM (Study 2). Approximately 3000 participants will be randomized in the study 1 and 1500 participants in the study 2. The primary endpoint is percent change in body weight from baseline at 72 weeks.

Вмешательства

Препарат Elecoglipron
Elecoglipron film-coated tablet once daily
Препарат Placebo
Placebo matching elecoglipron film-coated tablet once daily

Первичные конечные точки

Percent body weight loss [Срок оценки: 72 weeks]

Вторичные конечные точки (8)

Absolute body weight loss [Срок оценки: 72 weeks]
Total body weight loss of at least 5%, 10%, and 15% [Срок оценки: 72 weeks]
Percent body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline [Срок оценки: 72 weeks]
Waist circumference reduction [Срок оценки: 72 weeks]
Glycemic control [Срок оценки: 72 weeks]
Achieving normoglycemia in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline [Срок оценки: 72 weeks]
Study 2 only: Achieving glycemic control in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline [Срок оценки: 72 weeks]
Systolic blood pressure reduction [Срок оценки: 72 weeks]

Критерии участия

Критерии включения

Legal age of consent and at least 18 years old
Study 1 -

BMI ≥ 30 kg/m2 or
25 kg/m2 ≤ BMI < 30 kg/m2 with at least one of the following weight-related comorbidities:
Hypertension
Prediabetes
Dyslipidemia
Cardiovascular disease
Obstructive sleep apnea.
Study 2 - BMI ≥ 25 kg/m2 and T2DM defined as below:

Established diagnosis of T2DM
Without established diagnosis of T2DM and HbA1c ≥ 6.5% (48 mmol/mol) at the screening visit
Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)
History of at least one self-reported unsuccessful dietary effort to lose body weight.

Критерии исключения

Study 1 - Established diagnosis of T1DM or T2DM.
Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes:

T1DM
HbA1c ≥ 10% (86 mmol/mol) at the screening visit
Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.
Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis
History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Тройное слепое
Основная цель: Лечение