Идёт набор NCT07656727

A Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors

Фаза II С лечением Obesity and Cardiovascular Risk

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: Oral BGE-102, Oral Placebo Matching BGE-102.
Кому может быть актуально: Состояния в реестре: Obesity and Cardiovascular Risk. 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, Пуэрто-Рико
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 2, Randomized, Double-Blind, Dose-Range, Placebo-Controlled, 12-Week Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors

Обзор

The purpose of this study is to learn about the effects of BGE-102 on blood biomarkers including hsCRP, which is a lab value used to measure inflammation. BGE-102 decreases inflammation which may improve obesity and cardiovascular health. Participants will receive either BGE-102 or placebo. This study will be checking safety and tolerability of BGE-102.

Подробное описание

The purpose of this study is to assess the pharmacodynamics and safety of oral once a day (QD) dosing of BGE-102 at 3 dose levels compared to placebo over 12 weeks of treatment.

Study details include:

* The study duration will be approximately 20 weeks (5 months) including the following study periods: screening (4 weeks), treatment (12 weeks), and post treatment follow-up (4 weeks). * The visit frequency will be every 2 weeks for the first 4 weeks of the treatment period and every 4 weeks thereafter up to Week 16. * The treatment duration will be up to 12 weeks. BGE-102 will be given as Dose A, Dose B or Dose C QD capsules or placebo QD capsules for the entire 12-week treatment period.

Вмешательства

Препарат Oral BGE-102
Capsules
Препарат Oral Placebo Matching BGE-102
Capsules

Первичные конечные точки

Percent change in hsCRP (Dose A) [Срок оценки: Week 12]
Percent change in hsCRP (Dose B) [Срок оценки: Week 12]
Percent change in hsCRP (Dose C) [Срок оценки: Week 12]

Вторичные конечные точки (2)

Incidence of serious adverse events (SAEs) [Срок оценки: Up to Week 16]
Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to Week 16]

Критерии участия

Критерии включения

Obese Male and Female adults with BMI 32-42 kg/m²
Elevated blood test for hsCRP consistent with chronic systemic inflammation
At least one cardiovascular risk factor or metabolic syndrome feature
Stable background therapies and willing to maintain stable diet/exercise habits during the study

Критерии исключения

Type 1 diabetes,
Uncontrolled Type 2 diabetes,
Uncontrolled hypertension and /or hyperlipidemia
Recent weight change of 5% or more,
Use of weight-loss medications/programs
Clinically relevant medical condition(s) that put the participant at risk or will make implementation of the protocol or interpretation of the study difficult.
Clinically significant ECG abnormalities or arrhythmias
Use of prohibited medications (including GLP-1 therapies, immunosuppressants, chronic anti-inflammatory drugs, or moderate or strong CYP3A4 modulators)
Contraindications to MRI
Clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or take drugs that directly affect GI motility, have undergone prior surgical treatment for obesity (e.g., gastric bypass \[bariatric\] surgery or restrictive bariatric surgery), or have an endoscopic and/or device-based therapy for obesity
Women who are pregnant or nursing

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

Здоровые добровольцы: Нет