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Search / Trial NCT07011667

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.

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

TA

1 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