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
Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
APDP - Associação Protectora dos Diabéticos de Portugal
ACTIVE_NOT_RECRUITING
Lisbon
APDP - Associação Protectora dos Diabéticos de Portugal
NOT_YET_RECRUITING
Lisbon
CUF Descobertas
NOT_YET_RECRUITING
Lisbon
Hospital Cuf Descobertas S.A.
ACTIVE_NOT_RECRUITING
Lisbon
Unidade Local de Saude de Sao Joao E.P.E
ACTIVE_NOT_RECRUITING
Porto
Unidade Local De Saude De Matosinhos E.P.E.
ACTIVE_NOT_RECRUITING
Senhora Da Hora, Matosinhos
Hospital Luz Arrabida, S.A.
ACTIVE_NOT_RECRUITING
Vila Nova De Gaia
United Kingdom
Southmead Hospital
RECRUITING
Bristol
Addenbrooke's Hospital_Cambridge
ACTIVE_NOT_RECRUITING
Cambridge
Addenbrooke's Hospital_Cambridge
RECRUITING
Cambridge
WISDEM Centre
ACTIVE_NOT_RECRUITING
Coventry
University Hospital Aintree
ACTIVE_NOT_RECRUITING
Liverpool
Blizard Institute_Royal London Hospital
RECRUITING
London
Joint Clinical Research Facility - Swansea
RECRUITING
Swansea
Musgrove Park Hospital
RECRUITING
Taunton
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date:2025-02-10
Estimated Completion Date:2028-11-17
Participants
Target number of participants:400
Treatments
Experimental: CagriSema
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) after a dose escalation period of 16 weeks during the maintenance period for 88 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for one year.
Placebo_comparator: Placebo
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once weekly for 104 weeks. Participants randomised to this arm will be included in the extension phase for one year.