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Taking peoplePhase 3

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.

Key facts

Who runs it
Novo Nordisk A/S
Where
Baia Mare, Brasov, Bucharest, Buzău, Craiova, Oradea, Pitesti, Târgu Mureş, and Timisoara, RomaniaSee the 11 sitesAlso in 18 other countries, 284 sites
Trial code
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
Status
Recruiting
Phase
Phase 3
People taking part
2,500 people, planned
Started
21 May 2026
Expected to end
19 Apr 2028
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cagrisema
  • Semaglutide
Record updated
30 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults living with obesity, with or without type 2 diabetes. It compares two doses of CagriSema with semaglutide for weight loss.

Age
18 years or older
Sex
All sexes can join (sex assigned at birth, all gender identities).
Disease stage
Obesity with BMI of 35.0 kg/m^2 or higher. People without type 2 diabetes need HbA1c below 6.5% (48 mmol/mol). People with type 2 diabetes need HbA1c below 10% (86 mmol/mol).
Earlier treatment
No GLP-1 receptor agonist or amylin analogue (or medicine with that activity) in the 6 months before screening.
Biomarker or test result
HbA1c below 6.5% (48 mmol/mol) without type 2 diabetes; below 10% (86 mmol/mol) with type 2 diabetes.

Main reasons for not taking part

  • Self-reported body weight change of more than 5% in the 90 days before screening
  • Use of a GLP-1 receptor agonist or amylin analogue in the 6 months before screening

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Romania

Also in 18 other countries, 284 sites

  • 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

About the trial

What the trial wants to find out

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

The 3 groups in the trial

  • Cagrisema - dose level 1Treatment being tested

    Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks.

    Treatment: Cagrisema

  • Cagrisema - dose level 2Existing treatment, for comparison

    Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.

    Treatment: Cagrisema

  • SemaglutideExisting treatment, for comparison

    Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
CagriSema versus semaglutide for weight loss in obesity, with or without type 2 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
30 September 2026