Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
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: KAI-7535, Placebo.
- Кому может быть актуально
- Состояния в реестре: Obesity, Overweight. Базовые параметры: 18 лет — 75 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, Австралия
- 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, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
Обзор
The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Efficacy in participants with type 2 diabetes mellitus will be evaluated. Safety and tolerability and other weight-related outcomes will be evaluated in both types of participants.
Вмешательства
- Препарат KAI-7535
Oral tablets - Препарат Placebo
Oral tablets
Первичные конечные точки
- Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus [Срок оценки: Baseline, Week 44]
Вторичные конечные точки (7)
- Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus [Срок оценки: Baseline, Week 44]
- Change from Baseline in Body Mass Index (BMI) at Week 44 for Participants Without Diabetes Mellitus [Срок оценки: Baseline, Week 44]
- Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Without Diabetes Mellitus [Срок оценки: Week 44]
- Percent Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus [Срок оценки: Baseline, Week 44]
- Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus [Срок оценки: Baseline, Week 44]
- Change from Baseline in BMI at Week 44 for Participants Living with Type 2 Diabetes Mellitus [Срок оценки: Baseline, Week 44]
- Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Living with Type 2 Diabetes Mellitus [Срок оценки: Week 44]
Критерии участия
Критерии включения
- For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m\^2) or BMI ≥27 kg/m\^2 and a previous diagnosis of at least 1 of the following:
- Hypertension
- Dyslipidemia
- Obstructive sleep apnea
- Cardiovascular disease
- For participants living with type 2 diabetes mellitus and BMI ≥27 kg/m\^2 only:
- Diagnosis of type 2 diabetes mellitus
- On stable therapy for type 2 diabetes mellitus for at least 3 months prior to screening
Критерии исключения
- For participants without diabetes:
- Laboratory evidence of diabetes
- Taking a concomitant medication for the indication of glycemic control
- For participants living with type 2 diabetes mellitus only:
- History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year of screening
- History of severe hypoglycemia or hypoglycemia unawareness within 1 year of screening
- History of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that required acute treatment
- Started medications that may cause significant weight change within 3 months prior to screening, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers
- Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to screening
- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid carcinoma
- Uncontrolled hypertension or unstable cardiovascular disease
- History of chronic or acute pancreatitis
- Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect gastrointestinal motility
- History of suicide attempt
- History of significant active or unstable major depressive disorder or other severe psychiatric disorder
- Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide receptor agonist, or glucagon receptor agonist within the last 3 months prior to screening
Note: Additional inclusion/exclusion criteria may apply, per protocol.
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
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 31 центр
- Kailera Clinical Site — Chandler
- Kailera Clinical Site — Phoenix
- Kailera Clinical Site — Irvine
- Kailera Clinical Site — Lincoln
- Kailera Clinical Site — Northridge
- Kailera Clinical Site — Hamden
- Kailera Clinical Site — Jacksonville
- Kailera Clinical Site — Jupiter
- … и ещё 23 центра
Австралия · 5 центров
- Kailera Clinical Site — Dee Why
- Kailera Clinical Site — Miranda
- Kailera Clinical Site — Wollongong
- Kailera Clinical Site — Norwood
- Kailera Clinical Site — Altona N.
Идентификаторы
NCT: NCT07497880 · K7535-2101