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Активно (без набиране) Фаза 3 NCT06858839

Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Фаза 3 – широко изпитване преди одобрение
Заболявания: Obesity

Спонсор: Amgen

Налично на: БГ
Обобщение
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
Кой може да участва
Inclusion Criteria: * Age ≥ 18 years. * Body mass index ≥ 30 kg/m2 or ≥27 kg/m² to \< 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH). * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. Exclusion Criteria: * Type 1 or Typ2 diabetes mellitus. * Obesity induced by other endocrinologic disorders. * Self-reported change in body weight \> 5 kg within 90 days before screening. * Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2. * History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening. * History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening. * Lifetime history of suicide attempt.
Места на провеждане 16
Argentina (1)
Cedic - Centro de Investigacion Clinica
CABA , Buenos Aires
Австралия (1)
Emeritus Research Sydney
Botany , New South Wales
Белгия (1)
Universitair Ziekenhuis Antwerpen
Edegem
Канада (1)
tlc Diabetes and Endocrinology
Surrey , British Columbia
Чехия (1)
Medicus Services sro
Brandýs nad Labem
Дания (1)
Sanos Gandrup
Gandrup
Финландия (1)
Obesity Research Unit
Helsinki
Италия (1)
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
Bologna
Япония (1)
Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
Yokohama , Kanagawa
Полша (1)
Gabinet Leczenia Otylosci i Chorob Dietozaleznych dr hab n med Lucyna Ostrowska
Bialystok
Puerto Rico (1)
Ponce Medical School Foundation Inc
Ponce
Южна Корея (1)
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do
Испания (1)
Centro Periferico de Especialidades Bola Azul
Almería , Andalusia
Швейцария (1)
Universitaetsspital Basel
Basel
Великобритания (1)
Ormeau Clinical Trials Ltd
Belfast
САЩ (1)
Pinnacle Research Group LLC
Anniston , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
99 Years
Здрави доброволци
Не
Начална дата
12.03.2025
Крайна дата
16.04.2027
Регистрационен номер
NCT06858839
Източник
anzctr
Запитване за медицински туризъм

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