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Активно (без набиране) Фаза 3 NCT05567796

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Obesity

Спонсор: Novo Nordisk A/S

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Места на провеждане 22
Argentina (1)
Fundación CESIM
Santa Rosa , La Pampa Province
Австралия (1)
Northern Beaches Clinical Research
Brookvale , New South Wales
Белгия (1)
Imeldaziekenhuis - Bonheiden - Department of Endocrinology
Bonheiden
България (1)
Medical centre Asclepius OOD
Dupnitsa , Kyustendil
Канада (1)
C-endo Diab & Endo Clinic
Edmonton , Alberta
Дания (1)
Sjællands Universitetshospital, Køge - Medicinsk Afdeling
Køge , Region Sjælland
Финландия (1)
HUS Clinical Research Obesity Unit CRC
Helsinki
Франция (1)
APHP - LA PITIE SALPETRIERE _ Service de Nutrition
Paris
Индия (1)
Nirmal Hospital Pvt. Ltd.
Surat , Gujarat
Италия (1)
A.O.U. Consorziale Policlinico di Bari
Bari , BA
Япония (1)
Shinsapporo Seiryou Hospital_General Clinical Department
Sapporo , Hokkaido
Mexico (1)
Consultorio Arechavaleta Granell María del Rosario
Guadalajara , Jalisco
Нидерландия (1)
AmsterdamUMC AMC
Amsterdam
Полша (1)
50BIO.COM Sp. z o.o.
Bydgoszcz , Kujawsko-Pomorskie Voivodeship
Сърбия (1)
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad , Vojvodina
South Africa (1)
East Rand Physicians
Benoni , Gauteng
Южна Корея (1)
The Catholic University of Korea, Bucheon ST. Mary's Hospital
Bucheon-si , Gyeonggi-do
Испания (1)
Clinica Universitaria de Navarra
Pamplona , Navarre
Taiwan (1)
China Medical University Hospital
Taichung
Турция (1)
Baskent University Ankara Hospital
Ankara , Cankaya
Великобритания (1)
Princess Royal University Hospital
Orpington , Kent
САЩ (1)
Univ of Alabama Birmingham
Birmingham , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Здрави доброволци
Не
Начална дата
01.11.2022
Крайна дата
19.10.2026
Регистрационен номер
NCT05567796
Източник
anzctr
Запитване за медицински туризъм

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