ACTIVE_NOT_RECRUITING

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

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 with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.

Official Title

Long-term Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Placebo in Participants With Obesity

Quick Facts

Study Start:2025-02-10
Study Completion:2028-11-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06780449

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

Valley Clinical Trials
Covina, California, 91723
United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
United States
Yale University School Of Medicine
New Haven, Connecticut, 06519
United States
East West Medical Research Institute_Honolulu
Honolulu, Hawaii, 96814
United States
L-MARC Research Center
Louisville, Kentucky, 40213
United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303
United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
United States
Holston Medical Group_Bristol
Bristol, Tennessee, 37620
United States
North Texas Endocrine Center
Dallas, Texas, 75231
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 Date2025-02-10
Study Completion Date2028-11-17

Study Record Updates

Study Start Date2025-02-10
Study Completion Date2028-11-17

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity