Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With 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 exploring a new medication called maridebart cafraglutide to see how effective it is for adults with type 2 diabetes who are also overweight or have obesity. The main goal is to find out if this medication can help people lose more weight compared to a placebo, which is a treatment that does not contain the active drug. The trial is currently looking for participants aged 18 and older who have a body mass index (BMI) of 27 or higher and have tried to lose weight through diet and exercise without success.
To be eligible for this study, participants must have been diagnosed with type 2 diabetes and should not have certain health conditions, such as type 1 diabetes or a recent significant change in their weight. Those who qualify will have the opportunity to receive either the medication or a placebo while being monitored by healthcare professionals. This trial is important because it could lead to new treatments that help manage weight and improve overall health for people living with type 2 diabetes.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age ≥ 18 years.
- • Body mass index ≥ 27 kg/m\^2.
- • History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
- • Diagnosis of T2DM.
- Exclusion Criteria:
- • Type 1 diabetes mellitus.
- • Self-reported change in body weight \> 5 kg within 90 days before screening.
- • Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
- • Obesity induced by other endocrinologic disorders.
- • 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
Boston, Massachusetts, United States
Bristol, , United Kingdom
Hull, , United Kingdom
Leipzig, , Germany
Hamburg, , Germany
Blackpool, , United Kingdom
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Orange, California, United States
Balatonfured, , Hungary
Greenville, North Carolina, United States
Praha 10, , Czechia
Mesa, Arizona, United States
Trenton, New Jersey, United States
Brno, , Czechia
Firenze, , Italy
Berlin, , Germany
Toronto, Ontario, Canada
Seattle, Washington, United States
London, Ontario, Canada
Brampton, Ontario, Canada
Hamilton, Ontario, Canada
Debrecen, , Hungary
Praha, , Czechia
Morehead City, North Carolina, United States
San Juan, , Puerto Rico
Montreal, Quebec, Canada
Ely, , United Kingdom
Praha 4, , Czechia
Berlin, , Germany
Leipzig, , Germany
Cerritos, California, United States
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Budapest, , Hungary
Budapest, , Hungary
Hialeah, Florida, United States
Bad Krozingen, , Germany
Miami, Florida, United States
Komarom, , Hungary
Pomona, California, United States
Aki Gun, Hiroshima, Japan
Swidnik, , Poland
Rotherham, , United Kingdom
Orlando, Florida, United States
Milano, , Italy
Winnipeg, Manitoba, Canada
Seongnam Si, Gyeonggi Do, , Korea, Republic Of
Miami Lakes, Florida, United States
Las Vegas, Nevada, United States
Sarnia, Ontario, Canada
Ostrava, , Czechia
Praha 4, , Czechia
Praha 9, , Czechia
Baja, , Hungary
Montreal, Quebec, Canada
Denison, Texas, United States
Dallas, Texas, United States
Oldenburg, , Germany
Albany, New York, United States
North York, Ontario, Canada
Berlin, , Germany
Hamburg, , Germany
Blackpool, , United Kingdom
Meguro Ku, Tokyo, Japan
Canoga Park, California, United States
East Greenwich, Rhode Island, United States
Miami, Florida, United States
Kansas City, Missouri, United States
Budapest, , Hungary
Naka Shi, Ibaraki, Japan
Kashiwara Shi, Osaka, Japan
Markkleeberg, , Germany
Matsuyama Shi, Ehime, Japan
Austin, Texas, United States
Houston, Texas, United States
Elizabethton, Tennessee, United States
Pointe Claire, Quebec, Canada
Chula Vista, California, United States
Newton, Kansas, United States
Mobile, Alabama, United States
Mckinney, Texas, United States
Morehead City, North Carolina, United States
Warszawa, , Poland
Levis, Quebec, Canada
Lodz, , Poland
Brampton, Ontario, Canada
Warszawa, , Poland
Surrey, British Columbia, Canada
Nepean, Ontario, Canada
Minneapolis, Minnesota, United States
Caba, Buenos Aires, Argentina
Berlin, , Germany
Pardubice, , Czechia
San Antonio, Texas, United States
Euless, Texas, United States
Merrillville, Indiana, United States
Asheville, North Carolina, United States
Hamilton, Ontario, Canada
Ansan Si, Gyeonggi Do, , Korea, Republic Of
Cincinnati, Ohio, United States
Winter Park, Florida, United States
Manassas, Virginia, United States
Mito Shi, Ibaraki, Japan
Tsuchiura Shi, Ibaraki, Japan
Nyiregyhaza, , Hungary
Kumamoto Shi, Kumamoto, Japan
Sparks, Nevada, United States
Modesto, California, United States
Weston, Florida, United States
Gilbert, Arizona, United States
Escondido, California, United States
Riverside, Connecticut, United States
Wichita, Kansas, United States
Monroe, Louisiana, United States
Blue Ash, Ohio, United States
Corpus Christi, Texas, United States
Layton, Utah, United States
Morgantown, West Virginia, United States
West Des Moines, Iowa, United States
Euless, Texas, United States
Phoenix, Arizona, United States
Skokie, Illinois, United States
Kitakyusyu Shi, Fukuoka, Japan
Shizuoka Shi, Shizuoka, Japan
Mitaka Shi, Tokyo, Japan
Northridge, California, United States
San Diego, California, United States
Oak Brook, Illinois, United States
Park Ridge, Illinois, United States
Paducah, Kentucky, United States
Annapolis, Maryland, United States
Niagara Falls, Ontario, Canada
Concord, Ontario, Canada
Birmingham, , United Kingdom
Glasgow, , United Kingdom
Belfast, , United Kingdom
Elsterwerda, , Germany
Essen, , Germany
Hohenmoelsen, , Germany
Muenchen, , Germany
Muenster, , Germany
Katowice, , Poland
Lublin, , Poland
Leicester, , United Kingdom
Caba, Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Yambol, , Bulgaria
Halifax, Nova Scotia, Canada
Trois Rivieres, Quebec, Canada
Pardubice, , Czechia
Praha 8, , Czechia
Pribram Viii, , Czechia
Budapest, , Hungary
Debrecen, , Hungary
Lublin, , Poland
Oswiecim, , Poland
Pulawy, , Poland
Ruda Slaska, , Poland
Staszow, , Poland
Wroclaw, , Poland
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported