ACTIVE_NOT_RECRUITING

A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. Which dose of CagriSema participants will continue on is decided by chance. If participants get placebo in the main study, participants will get CagriSema in the extension study. Participants will take one injection of study medicine once a week. The study will last for about 3 years and 3 months.

Official Title

Efficacy and Safety of Cagrilintide s.c. in Combination With Semaglutide s.c. (CagriSema s.c.) Once Weekly for Weight Management and Long-term Weight Maintenance in Participants With Obesity

Quick Facts

Study Start:2025-06-03
Study Completion:2028-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07011667

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female (sex at birth).
  2. * Age 18 years or above at the time of signing the informed consent.
  3. * BMI ≥ 30.0 kilogram per square meter (kg/m\^2) at screening.
  4. * Participant has a wish to lose at least 25% of body weight within 80 weeks from randomisation.
  1. * Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening.
  2. * History of type 1 or type 2 diabetes.

Contacts and Locations

Principal Investigator

Clinical Transparency (dept. 2834)
STUDY_DIRECTOR
Novo Nordisk A/S

Study Locations (Sites)

FDRC
Costa Mesa, California, 92627
United States
Linda Vista Health Care Ctr
San Diego, California, 92111
United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
United States
Northeast Research Institute
Fleming Island, Florida, 32003
United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, 32216
United States
South Broward Research LLC
Miramar, Florida, 33027
United States
Florida Inst For Clin Res LLC
Orlando, Florida, 32825
United States
Oviedo Medical Research, LLC
Oviedo, Florida, 32765
United States
Cnt for Diab,Obes, and Metab
Pembroke Pines, Florida, 33024
United States
Hope Clin Res & Wellness
Conyers, Georgia, 30094
United States
Endocrine Research Solutions
Roswell, Georgia, 30076
United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640
United States
Endeavor Health
Skokie, Illinois, 60077
United States
Evanston Premier Hlthcr Res
Skokie, Illinois, 60077
United States
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260
United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, 50266
United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, 49620
United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303
United States
Amicis Centers of Clinical Research
St Louis, Missouri, 63128
United States
Mercury Str Med Grp, PLLC
Butte, Montana, 59701
United States
Southgate Medical Group, LLP
West Seneca, New York, 14224
United States
Great Lakes Medical Research
Westfield, New York, 14787
United States
University of North Carolina
Chapel Hill, North Carolina, 27514
United States
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, 27405
United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408
United States
Accellacare_NC
Raleigh, North Carolina, 27609
United States
Piedmont Healthcare/Research
Statesville, North Carolina, 28625
United States
Accellacare
Wilmington, North Carolina, 28401
United States
New Venture Medical Research
Wadsworth, Ohio, 44281-9236
United States
Lynn Institute of Norman
Norman, Oklahoma, 73072
United States
Clinical Res Collaborative
Cumberland, Rhode Island, 02864
United States
Coastal Carolina Res Ctr
North Charleston, South Carolina, 29405
United States
Hillcrest Clinical Research
Simpsonville, South Carolina, 29681-1538
United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
United States
Holston Medical Group
Kingsport, Tennessee, 37660
United States
Clinical Research Associates
Nashville, Tennessee, 37203
United States
Amarillo Med Spec LLP
Amarillo, Texas, 79106
United States
Velocity Clin Res, Dallas
Dallas, Texas, 75230
United States
PlanIt Research, PLLC
Houston, Texas, 77079
United States
Radiance Clinical Research
Lampasas, Texas, 76550
United States
Northeast Clinical Research of San Antonio
Schertz, Texas, 78154
United States
Washington Cntr Weight Mgmt
Arlington, Virginia, 22206
United States
Health Res of Hampton Roads
Newport News, Virginia, 23606
United States
Selma Medical Associates
Winchester, Virginia, 22601-3834
United States
Rainier Clin Res Ctr Inc
Renton, Washington, 98057
United States

Collaborators and Investigators

Sponsor: Novo Nordisk A/S

  • Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-03
Study Completion Date2028-11-01

Study Record Updates

Study Start Date2025-06-03
Study Completion Date2028-11-01

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity