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Active (not recruiting) Phase 3 NCT06858839

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

Phase 3 – large-scale trial before approval
Conditions: Obesity

Sponsor: Amgen

trial.available_in: БГ
Overview
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
Who can participate
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.
Locations 16
Argentina (1)
Cedic - Centro de Investigacion Clinica
CABA , Buenos Aires
Australia (1)
Emeritus Research Sydney
Botany , New South Wales
Belgium (1)
Universitair Ziekenhuis Antwerpen
Edegem
Canada (1)
tlc Diabetes and Endocrinology
Surrey , British Columbia
Czech Republic (1)
Medicus Services sro
Brandýs nad Labem
Denmark (1)
Sanos Gandrup
Gandrup
Finland (1)
Obesity Research Unit
Helsinki
Italy (1)
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
Bologna
Japan (1)
Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
Yokohama , Kanagawa
Poland (1)
Gabinet Leczenia Otylosci i Chorob Dietozaleznych dr hab n med Lucyna Ostrowska
Bialystok
Puerto Rico (1)
Ponce Medical School Foundation Inc
Ponce
South Korea (1)
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do
Spain (1)
Centro Periferico de Especialidades Bola Azul
Almería , Andalusia
Switzerland (1)
Universitaetsspital Basel
Basel
United Kingdom (1)
Ormeau Clinical Trials Ltd
Belfast
United States (1)
Pinnacle Research Group LLC
Anniston , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No
Start date
12.03.2025
Completion date
16.04.2027
Registry ID
NCT06858839
Source
anzctr
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