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Clinical Trials in Belgium / NCT06780449
Active, not recruiting Phase 3

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

NCT06780449 · tracked via the Priya Life Science Belgium tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2025-02-10
Last updated
2026-01-20

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

Cagrilintide →Semaglutide →Placebo cagrilintidePlacebo semaglutide

Cagrilintide: Participants will receive cagrilintide subcutaneously.

Semaglutide: Participants will receive semaglutide subcutaneously.

Placebo cagrilintide: Participants will receive placebo matched to cagrilintide subcutaneously.

Placebo semaglutide: Participants will receive placebo matched to semaglutide subcutaneously.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Relative change in body weight — From baseline (week 0) to week 104
    Measured in percentage (%).

Trial sites (36)

FacilityCityRegionStatus
Valley Clinical Trials Covina California
Diablo Clinical Research, Inc. Walnut Creek California
Yale University School Of Medicine New Haven Connecticut
East West Medical Research Institute_Honolulu Honolulu Hawaii
L-MARC Research Center Louisville Kentucky
StudyMetrix Research LLC City of Saint Peters Missouri
Spartanburg Medical Research Spartanburg South Carolina
Holston Medical Group_Bristol Bristol Tennessee
North Texas Endocrine Center Dallas Texas
Washington Cntr Weight Mgmt Arlington Virginia
Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie Brussels Belgium
UZA - UZ Antwerpen - Department of Endocrinology Edegem Belgium
UZ Leuven - Endocrinology Leuven Belgium
CHU Helora - Hôpital de Mons - Site Constantinople Mons Belgium
Dr. M.B. Jones Inc Victoria British Columbia
Nova Scotia Health Authority Halifax Nova Scotia
Premier Clinical Trial Research Network (PCTRN) Hamilton Ontario
Alpha Recherche Clinique - Lebourgneuf Québec Canada
Aarhus Universitetshospital, Steno Diabetes Center Aarhus Aarhus Denmark
Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden Esbjerg Denmark
Gentofte Hospital - Center for Klinisk Metabolisk Forskning Hellerup Denmark
Hvidovre Hospital Endokrinologisk forsknings afsnit 159 Hvidovre Denmark
Sjællands Universitetshospital, Køge - Medicinsk Afdeling Køge Denmark
ULS De Matosinhos E.P.E.- Hospital Pedro Hispano Senhora Da Hora, Matosinhos Matosinhos
APDP - Associação Protectora dos Diabéticos de Portugal Lisbon Portugal
CUF Descobertas Lisbon Portugal
Hospital Cuf Descobertas S.A. Lisbon Portugal
Unidade Local de Saude de Sao Joao E.P.E Porto Portugal
Hospital Luz Arrabida, S.A. Vila Nova de Gaia Portugal
Southmead Hospital Bristol United Kingdom
Addenbrooke's Hospital_Cambridge Cambridge United Kingdom
University Hospital Coventry - WISDEM Centre Coventry United Kingdom
Aintree University Hospital Liverpool United Kingdom
Royal London Hospital - Blizard Institute London United Kingdom
Joint Clinical Research Facility - Swansea Swansea United Kingdom
Musgrove Park Hospital Taunton United Kingdom

On this site

📄 Ozempic (semaglutide) drug profile →

More Novo Nordisk A/S trials in Belgium

A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight Recruiting
SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity Active, not recruiting
Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH) Active, not recruiting
STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss Active, not recruiting
A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A Active, not recruiting

Other trials for the same condition

A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin Recruiting
Differences in Extracellular Vesicles From Adipose Tissue of Individuals With Obesity. Recruiting
Changes in Body Fat and Morphologic Characteristics Associated With OSA Resolution After Bariatric Surgery Recruiting
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight Recruiting
SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06780449 on ClinicalTrials.gov ↗ ← All trials in Belgium