CagriSema versus semaglutide for weight loss in obesity, with or without type 2 diabetes
Compares CagriSema with semaglutide for weight loss in adults with obesity.
Plain-language title generated from the registry record
Registry title: A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
Key facts
- Where
- Baia Mare, Brasov, Bucharest, Buzău, Craiova, Oradea, Pitesti, Târgu Mureş, and Timisoara, RomaniaSee the 11 sites
- Phase
- Phase 3
Where in Romania
- Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop LaviniaBaia Mare, RomaniaNo longer taking part
- Mariodiab Clinic S.R.L.Brasov, RomaniaNo longer taking part
- Nicodiab S.R.L.Bucharest, RomaniaNo longer taking part
- Mat Cord Biomedica S.R.L.Buzău, RomaniaNo longer taking part
- Top Diabet S.R.L.Craiova, RomaniaNo longer taking part
- Grandmed S.R.L.Oradea, RomaniaNo longer taking part
- Spitalul Clinic Judetean De Urgenta BihorOradea, RomaniaNo longer taking part
- Sal Med S.R.L.Pitesti, RomaniaNo longer taking part
- Mediab S.R.L.Târgu Mureş, RomaniaNo longer taking part
- Cabinet Medical Dr Geru S.R.L.Timisoara, RomaniaNo longer taking part
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu TimisoaraTimisoara, RomaniaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT07564414EU 2025-522488-14-00
- Record updated
- 30 September 2026
- Original description
This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeksRead full original descriptionShow less
A Clinical Study to Compare Efficacy and Safety of Two Different Doses of CagriSema and Semaglutide in Participants With Obesity With or Without Type 2 Diabetes
This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks
Inclusion: Male or female (sex assigned at birth, inclusive of all gender identities); Age 18 years or above at the time of signing the informed consent; BMI≥ 35.0 kg/m\^2; Participants without T2D: No history of T2D and HbA1c < 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c < 10% (< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.
Exclusion: A self-reported change in body weight > 5% within 90 days before screening, irrespective of medical records; Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.