A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Launched by NOVO NORDISK A/S · Jun 1, 2025
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called CagriSema to see how well it helps people with obesity lose weight and keep that weight off over the long term. The trial has two parts: the main study and an extension study. In the main study, participants will receive either CagriSema or a placebo (which is a dummy medicine with no active ingredients). The participants have a better chance of receiving CagriSema than the placebo. After the main study, those who received CagriSema will continue with the same medication, while those who received the placebo will switch to CagriSema in the extension study. Participants will take one injection once a week for about 3 years and 3 months.
To take part in this trial, individuals must be at least 18 years old and have a body mass index (BMI) of 30 or higher, which indicates obesity. They should also want to lose at least 25% of their body weight over about 80 weeks. However, people with certain health conditions, like diabetes, cannot join the study. Overall, this trial aims to provide valuable information on how effective CagriSema is for helping people manage their weight.
Gender
ALL
Eligibility criteria
- key Inclusion Criteria:
- • Male or female (sex at birth).
- • Age 18 years or above at the time of signing the informed consent.
- • BMI ≥ 30.0 kilogram per square meter (kg/m\^2) at screening.
- • Participant has a wish to lose at least 25% of body weight within 80 weeks from randomisation.
- key Exclusion Criteria:
- • Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening.
- • History of type 1 or type 2 diabetes.
About Novo Nordisk A/S
Novo Nordisk A/S is a global healthcare company headquartered in Denmark, specializing in the research, development, manufacturing, and marketing of innovative pharmaceuticals, particularly in the fields of diabetes care, obesity treatment, and hormone replacement therapies. With a strong commitment to improving patient outcomes, Novo Nordisk invests significantly in clinical trials to advance scientific knowledge and develop effective therapies. The company is dedicated to sustainability and ethical practices, striving to deliver high-quality healthcare solutions while addressing the evolving needs of patients worldwide. Through collaboration and innovation, Novo Nordisk aims to lead the way in transforming diabetes and other chronic diseases into manageable conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Walnut Creek, California, United States
Kingsport, Tennessee, United States
Chapel Hill, North Carolina, United States
Westfield, New York, United States
Nashville, Tennessee, United States
Spartanburg, South Carolina, United States
Statesville, North Carolina, United States
Roswell, Georgia, United States
Oviedo, Florida, United States
Chicago, Illinois, United States
Schertz, Texas, United States
Fleming Island, Florida, United States
Norman, Oklahoma, United States
Wilmington, North Carolina, United States
Newport News, Virginia, United States
Jacksonville, Florida, United States
Buckley, Michigan, United States
Saint Peters, Missouri, United States
Butte, Montana, United States
West Seneca, New York, United States
Greensboro, North Carolina, United States
Simpsonville, South Carolina, United States
Amarillo, Texas, United States
Houston, Texas, United States
Longview, Texas, United States
Winchester, Virginia, United States
San Diego, California, United States
Saint Louis, Missouri, United States
Miramar, Florida, United States
Conyers, Georgia, United States
Skokie, Illinois, United States
Cumberland, Rhode Island, United States
Renton, Washington, United States
Costa Mesa, California, United States
Greensboro, North Carolina, United States
Wadsworth, Ohio, United States
Dallas, Texas, United States
Arlington, Virginia, United States
Lampasas, Texas, United States
Indianapolis, Indiana, United States
Raleigh, North Carolina, United States
North Charleston, South Carolina, United States
Orlando, Florida, United States
Skokie, Illinois, United States
West Des Moines, Iowa, United States
Pembroke Pines, Florida, United States
Patients applied
Trial Officials
Clinical Transparency (dept. 2834)
Study Director
Novo Nordisk A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported