Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07564414

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CEMEDIC, CABA, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Cagrisema

Drug

Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.

semaglutide

Drug

Semaglutide will be administered subcutaneously.

Primary outcomes

  1. Relative change in body weight

    Time frame: From randomisation (week 0) to end of treatment (week 72)

    Measured as percentage (%).

Secondary outcomes

  1. Relative change in body weight

    Time frame: From randomisation (week 0) to end of treatment (week 72)

    Measured as %.

  2. Change in Body Mass Index (BMI)

    Time frame: From randomisation (week 0) to end of treatment (week 72)

    Measured as kilograms per square metre (kg/m^2).

  3. Number of participants who achieve greater than or equal to (≥) 30% weight reduction

    Time frame: From randomisation (week 0) to end of treatment (week 72)

    Measured as count of participants.

  4. Number of participants who achieve ≥25% weight reduction

    Time frame: From randomisation (week 0) to end of treatment (week 72)

    Measured as count of participants.

  5. Number of participants who achieve greater ≥ 20% weight reduction

    Time frame: From randomisation (week 0) to end of treatment (week 72)

    Measured as count of participants.

  6. Change in waist circumference

    Time frame: From randomisation (week 0) to end of treatment (week 72)

    Measured in centimetre (cm).

  7. Mean change in body weight

    Time frame: From randomisation (week 0) to end of treatment (week 72)

    Measured in kilograms (kg).

  8. Number of participants who achieve a BMI less than (<) 30 kg/m^2

    Time frame: From randomisation (week 0) to end of treatment (week 72)

    Measured as count of participants.

  9. Number of participants who achieve BMI <27 kg/m^2

    Time frame: end of treatment (week 72)

    Measured as count of participants.

  10. Number of participants who achieve normal BMI, defined as 18.5 lesser than or equal to (≤) BMI < 25 kg/m^2

    Time frame: At end of treatment (week 72)

    Measured as count of participants.

  11. Number of participants who achieve a waist-to-height ratio < 0.53

    Time frame: At end of treatment (week 72)

    Measured as count of participants.

  12. Ratio to baseline : Total cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 72)

    Measured in terms of ratio.

  13. Ratio to baseline : High density lipoprotein (HDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 72)

    Measured in terms of ratio.

  14. Ratio to baseline : Low density lipoprotein (LDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 72)

    Measured in terms of ratio.

  15. Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 72)

    Measured in terms of ratio.

  16. Ratio to baseline : Triglycerides

    Time frame: From baseline (week 0) to end of treatment (week 72)

    Measured in terms of ratio.

  17. Ratio to baseline: Free fatty acids

    Time frame: From baseline (week 0) to end of treatment (week 72)

    Measured in terms of ratio.

  18. Ratio to baseline : Non-HDL cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 72)

    Measured in terms of ratio.

  19. Change in Short-Form-36 Health Survey Version 2.0 (SF-36v2) physical Function

    Time frame: From randomisation (week 0) to end of treatment (week 72)

    Measured as score on a scale. The SF-36v2 acute measures health-related quality of life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. Physical functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being.

  20. Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) physical function

    Time frame: From randomisation (week 0) to end of treatment (week 72)

    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning.

  21. Change in glycated haemoglobin (HbA1c)

    Time frame: From randomisation (week 0) to end of treatment (week 72)

    Measured in %-points.

  22. Number of participants who achieve HbA1c <6.5%

    Time frame: At end of treatment (week 72)

    Measured as count of participants.

  23. Number of participants who achieve normal HbA1c <5.7%

    Time frame: At end of treatment (week 72)

    Measured as count of participants.

  24. Number of treatment-emergent adverse events (TEAEs)

    Time frame: From randomisation (week 0) to end of study (week 80)

    Measured in number of events.

  25. Number of treatment-emergent serious adverse events (TESAEs)

    Time frame: From randomisation (week 0) to end of study (week 80)

    Measured in number of events.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 4, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.