Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
Launched by AMGEN · Feb 28, 2025
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called maridebart cafraglutide to see if it can help adults who are overweight or obese lose more weight compared to a placebo, which is an inactive treatment. The main goal is to find out if this medication can lead to a significant decrease in body weight. The trial is currently looking for participants aged 18 and older who have a body mass index (BMI) of 30 or higher, or a BMI between 27 and 30 with certain weight-related health issues like high blood pressure or heart problems. Importantly, participants should have tried to lose weight before through diet and exercise but were not successful.
If you join this study, you will receive either the medication or a placebo for a set period of time, and your weight will be monitored throughout the trial. There are some criteria that would prevent someone from participating, such as having diabetes, certain thyroid conditions, or a history of severe psychiatric disorders. This trial could be an opportunity to explore a new treatment for weight loss, and participants will receive regular check-ups and support from the research team during the study.
Gender
ALL
Eligibility criteria
- 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.
About Amgen
Amgen is a leading global biotechnology company dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. With a strong focus on areas such as oncology, cardiovascular disease, and inflammation, Amgen leverages advanced science and technology to address complex medical needs. The company is committed to improving patient outcomes through rigorous clinical trials and robust research initiatives, ensuring the highest standards of safety and efficacy in its products. With a rich pipeline of cutting-edge therapies, Amgen continues to be at the forefront of biopharmaceutical advancements, making a significant impact on healthcare worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Winston Salem, North Carolina, United States
Jacksonville, Florida, United States
Rochester, New York, United States
Walnut Creek, California, United States
St Leonards, New South Wales, Australia
Hull, , United Kingdom
Hvidovre, , Denmark
Gent, , Belgium
Leipzig, , Germany
Oulu, , Finland
Hamburg, , Germany
San Antonio, Texas, United States
Blackpool, , United Kingdom
Hellerup, , Denmark
Louisville, Kentucky, United States
Seoul, , Korea, Republic Of
Edegem, , Belgium
Newport News, Virginia, United States
New Haven, Connecticut, United States
Busan, , Korea, Republic Of
Praha 10, , Czechia
Anniston, Alabama, United States
Waterbury, Connecticut, United States
Incheon, , Korea, Republic Of
Brno, , Czechia
Pamplona, Navarra, Spain
Daegu, , Korea, Republic Of
Basel, , Switzerland
Bad Mergentheim, , Germany
Firenze, , Italy
Berlin, , Germany
Pisa, , Italy
Zuerich, , Switzerland
Meadowbrook, Queensland, Australia
Meridian, Idaho, United States
Oaklands Park, South Australia, Australia
Geneve 14, , Switzerland
Valencia, , Spain
Praha, , Czechia
Chicoutimi, Quebec, Canada
Quebec, , Canada
Seoul, , Korea, Republic Of
San Diego, California, United States
San Juan, , Puerto Rico
Sevilla, , Spain
Winchester, Virginia, United States
Sugar Land, Texas, United States
Ely, , United Kingdom
Newport, Pennsylvania, United States
Praha 4, , Czechia
Berlin, , Germany
Leipzig, , Germany
Miami, Florida, United States
Ocala, Florida, United States
Daejeon, , Korea, Republic Of
Montclair, California, United States
Seoul, , Korea, Republic Of
Ponce, , Puerto Rico
Hialeah, Florida, United States
Seoul, , Korea, Republic Of
Houston, Texas, United States
Poznan, , Poland
Bad Krozingen, , Germany
Herlev, , Denmark
Leuven, , Belgium
Rotherham, , United Kingdom
Seoul, , Korea, Republic Of
Knoxville, Tennessee, United States
Riverside, California, United States
Orlando, Florida, United States
Milano, , Italy
Seongnam Si, Gyeonggi Do, , Korea, Republic Of
Yangsan Si, Gyeongsangnam Do, , Korea, Republic Of
Las Vegas, Nevada, United States
Greenville, South Carolina, United States
Mesquite, Texas, United States
Scarborough, Ontario, Canada
Brandys Nad Labem, , Czechia
Ostrava, , Czechia
Praha 9, , Czechia
Herlev, , Denmark
Vega Baja, , Puerto Rico
Cincinnati, Ohio, United States
St Jean Sur Richelieu, Quebec, Canada
Dallas, Texas, United States
Oldenburg, , Germany
North York, Ontario, Canada
Berlin, , Germany
Hamburg, , Germany
Blackpool, , United Kingdom
Gainesville, Georgia, United States
Kotara, New South Wales, Australia
Dallas, Texas, United States
Sankt Gallen, , Switzerland
Botany, New South Wales, Australia
Poznan, , Poland
Sevilla, , Spain
East Greenwich, Rhode Island, United States
Miami, Florida, United States
Chuo Ku, Tokyo, Japan
Hamilton, Ontario, Canada
Kansas City, Missouri, United States
Jacksonville, Florida, United States
Mechelen, , Belgium
Gandrup, , Denmark
Olomouc, , Czechia
Skokie, Illinois, United States
Honolulu, Hawaii, United States
Long Beach, California, United States
Long Beach, California, United States
Markkleeberg, , Germany
Liège, , Belgium
Goyang Si, Gyeonggi Do, , Korea, Republic Of
Knoxville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Castilleja De La Cuesta, , Spain
Orlando, Florida, United States
Cincinnati, Ohio, United States
Herning, , Denmark
Hickory, North Carolina, United States
Newton, Kansas, United States
Mobile, Alabama, United States
Marrero, Louisiana, United States
Frankfurt Am Main, , Germany
Southfield, Michigan, United States
Lodz, , Poland
Terrebonne, Quebec, Canada
Toronto, Ontario, Canada
Mainz, , Germany
Surrey, British Columbia, Canada
Shinjuku Ku, Tokyo, Japan
Berlin, , Germany
Bologna, , Italy
Huelva, , Spain
Miranda, New South Wales, Australia
Wollongong, New South Wales, Australia
Euless, Texas, United States
San Diego, California, United States
Las Vegas, Nevada, United States
Santa Ana, California, United States
Almeria, , Spain
Baton Rouge, Louisiana, United States
Ansan Si, Gyeonggi Do, , Korea, Republic Of
Norwood, South Australia, Australia
Ponce, , Puerto Rico
Camberwell, Victoria, Australia
Altona North, Victoria, Australia
Suwon Si Gyeonggi Do, , Korea, Republic Of
Fountain Valley, California, United States
Weston, Florida, United States
Union City, Georgia, United States
Chicago, Illinois, United States
Shelby, North Carolina, United States
Desoto, Texas, United States
El Paso, Texas, United States
Pharr, Texas, United States
Bountiful, Utah, United States
Layton, Utah, United States
Saint George, Utah, United States
Milwaukee, Wisconsin, United States
Daphne, Alabama, United States
Orlando, Florida, United States
Fayette, Mississippi, United States
Vestal, New York, United States
Phoenix, Arizona, United States
Margate, Florida, United States
Skokie, Illinois, United States
Norman, Oklahoma, United States
Arlington, Virginia, United States
Chiyoda Ku, Tokyo, Japan
Hachioji Shi, Tokyo, Japan
Yokohama Shi, Kanagawa, Japan
Minato Ku, Tokyo, Japan
Sanlucar De Barrameda, , Spain
Suginami Ku, Tokyo, Japan
Heidelberg West, Victoria, Australia
Sankt Gallen, , Switzerland
Kortrijk, , Belgium
Thunder Bay, Ontario, Canada
Birmingham, , United Kingdom
Glasgow, , United Kingdom
Belfast, , United Kingdom
Penzance, , United Kingdom
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Boussu, , Belgium
Oshawa, Ontario, Canada
Toronto, Ontario, Canada
Havirov, , Czechia
Praha 3, , Czechia
Praha, , Czechia
Helsinki, , Finland
Kuopio, , Finland
Bad Homburg, , Germany
Elsterwerda, , Germany
Essen, , Germany
Essen, , Germany
Hohenmoelsen, , Germany
Kassel, , Germany
Luebeck, , Germany
Muenchen, , Germany
Muenster, , Germany
Oberwuerzbach, , Germany
Villingen Schwenningen, , Germany
Wangen Im Allgaeu, , Germany
Anyang Si, Gyeonggi Do, , Korea, Republic Of
Bucheon, Gyeonggi Do, , Korea, Republic Of
Seoul, , Korea, Republic Of
Bialystok, , Poland
Bialystok, , Poland
Debica, , Poland
Gdynia, , Poland
Katowice, , Poland
Lublin, , Poland
Warszawa, , Poland
Warszawa, , Poland
A Coruña, Galicia, Spain
Pozuelo De Alarcon, Madrid, Spain
Palma, , Spain
Cornwall, , United Kingdom
Leicester, , United Kingdom
Newcastle Upon Tyne, , United Kingdom
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported