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Active (not recruiting) Phase 3 NCT05567796

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

Phase 3 – large-scale trial before approval
Conditions: Obesity

Sponsor: Novo Nordisk A/S

trial.available_in: БГ
Overview
This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms. Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.
Who can participate
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 30.0 kilograms per square meter (kg/m\^2) or b) BMI greater than or equal to 27.0 kg/m\^2 with the presence of at least one weight-related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease Exclusion Criteria: \- Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening b) History of type 1 or type 2 diabetes mellitus
Locations 22
Argentina (1)
Fundación CESIM
Santa Rosa , La Pampa Province
Australia (1)
Northern Beaches Clinical Research
Brookvale , New South Wales
Belgium (1)
Imeldaziekenhuis - Bonheiden - Department of Endocrinology
Bonheiden
Bulgaria (1)
Medical centre Asclepius OOD
Dupnitsa , Kyustendil
Canada (1)
C-endo Diab & Endo Clinic
Edmonton , Alberta
Denmark (1)
Sjællands Universitetshospital, Køge - Medicinsk Afdeling
Køge , Region Sjælland
Finland (1)
HUS Clinical Research Obesity Unit CRC
Helsinki
France (1)
APHP - LA PITIE SALPETRIERE _ Service de Nutrition
Paris
India (1)
Nirmal Hospital Pvt. Ltd.
Surat , Gujarat
Italy (1)
A.O.U. Consorziale Policlinico di Bari
Bari , BA
Japan (1)
Shinsapporo Seiryou Hospital_General Clinical Department
Sapporo , Hokkaido
Mexico (1)
Consultorio Arechavaleta Granell María del Rosario
Guadalajara , Jalisco
Netherlands (1)
AmsterdamUMC AMC
Amsterdam
Poland (1)
50BIO.COM Sp. z o.o.
Bydgoszcz , Kujawsko-Pomorskie Voivodeship
Serbia (1)
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad , Vojvodina
South Africa (1)
East Rand Physicians
Benoni , Gauteng
South Korea (1)
The Catholic University of Korea, Bucheon ST. Mary's Hospital
Bucheon-si , Gyeonggi-do
Spain (1)
Clinica Universitaria de Navarra
Pamplona , Navarre
Taiwan (1)
China Medical University Hospital
Taichung
Turkey (1)
Baskent University Ankara Hospital
Ankara , Cankaya
United Kingdom (1)
Princess Royal University Hospital
Orpington , Kent
United States (1)
Univ of Alabama Birmingham
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Healthy volunteers
No
Start date
01.11.2022
Completion date
19.10.2026
Registry ID
NCT05567796
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.