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Search / Trial NCT06780449

A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity

Launched by NOVO NORDISK A/S · Jan 13, 2025

Trial Information

Current as of August 02, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called CagriSema to see how effectively it helps people with obesity lose weight over a long period. Participants in the study will be randomly assigned to receive either CagriSema or a "dummy medicine" (which looks like the real medicine but has no active ingredients). The study has two parts: the first part lasts for 2 years, and if participants continue into the second part, it will last another year. During the second part, those who received the dummy medicine will start taking CagriSema, while those who took CagriSema may have their dose gradually reduced.

To be eligible for this trial, participants need to be at least 18 years old and have a body mass index (BMI) of 35 or higher, which indicates obesity. However, individuals with certain health conditions, like diabetes, cannot participate. Throughout the study, participants will be closely monitored for any side effects from the medication. It’s important to note that CagriSema is not yet available for doctors to prescribe, so this study is a crucial step in understanding its long-term effects on weight loss.

Gender

ALL

Eligibility criteria

  • Inclusion criteria:
  • Male or female.
  • Age above or equal to 18 years at the time of signing informed consent.
  • Body mass index (BMI) greater than or equal to (\>=) 35.0 kilograms per meter square (kg/m\^2).
  • Exclusion criteria:
  • Glycated haemoglobin (HbA1c) \>= 6.5 percent (48 millimoles 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.

Locations

Bristol, , United Kingdom

Walnut Creek, California, United States

Liverpool, , United Kingdom

New Haven, Connecticut, United States

Louisville, Kentucky, United States

Spartanburg, South Carolina, United States

Dallas, Texas, United States

Taunton, , United Kingdom

Halifax, Nova Scotia, Canada

Esbjerg, , Denmark

Lisboa, , Portugal

Porto, , Portugal

Køge, , Denmark

Covina, California, United States

Aarhus, , Denmark

Saint Peters, Missouri, United States

Victoria, British Columbia, Canada

Swansea, , United Kingdom

Bristol, Tennessee, United States

Bruxelles, , Belgium

Edegem, , Belgium

Leuven, , Belgium

Vila Nova De Gaia, , Portugal

Coventry, , United Kingdom

Cambridge, , United Kingdom

Arlington, Virginia, United States

Hellerup, , Denmark

Hvidovre, , Denmark

Boussu, , Belgium

Honolulu, Hawaii, United States

Senhora Da Hora, Matosinhos, Portugal

Hamilton, Ontario, Canada

Quebec, , Canada

Lisboa, , Portugal

London, , United Kingdom

Senhora Da Hora, Matosinhos, Matosinhos, Portugal

Porto, , Portugal

Vila Nova De Gaia, , Portugal

London, , United Kingdom

Senhora Da Hora, Matosinhos, Matosinhos, Portugal

Lisboa, , Portugal

Patients applied

RM

AB

2 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