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OpenTrials
Completed

NCT Number: NCT06221969

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires Mácula, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes ≥ 180 days before screening.
  • Stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor.
  • HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
  • Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Exclusion criteria

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
  • Renal impairment with estimated Glomerular Filtration Rate < 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) as determined by central laboratory at screening.
  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Treatment and study plan

Cagrilintide

Drug

Cagrilintide will be administered subcutaneously.

semaglutide

Drug

Semaglutide will be administered subcutaneously.

Tirzepatide

Drug

Tirzepatide will be administered subcutaneously.

Primary outcomes

  1. Change in glycated haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage (%)-points.

  2. Relative change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage (%).

Secondary outcomes

  1. Change in HbA1c

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in %-points.

  2. Change in fasting plasma glucose (FPG)

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in millimoles per liter (mmol/L).

  3. Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol])

    Time frame: At end of treatment (week 68)

    Count of participant

  4. Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol)

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Count of participant

  5. Achievement of greater than or equal to (≥) 5% weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Count of participant

  6. Achievement of ≥ 10% weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Count of participant

  7. Achievement of ≥ 15 % weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Count of participant

  8. Achievement of ≥ 20 % weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Count of participant

  9. Change in systolic blood pressure

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in millimeters of mercury(mmHg).

  10. Change in diastolic blood pressure

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in mmHg.

  11. Change in waist circumference

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in centimeter (cm).

  12. Ratio to baseline in lipids: Total cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in ratio.

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

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in ratio.

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

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in ratio.

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

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in ratio.

  16. Ratio to baseline in lipids: Triglycerides

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in ratio.

  17. Ratio to baseline in lipids: non-HDL cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in ratio.

  18. Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey

    Time frame: From baseline (week 0) to end of treatment (week 68)

    The SF-36 v2 will be used to measure differences in quality of life and mental wellbeing. The scores 0-100 (where higher scores indicated a better quality of life and mental wellbeing) from the SF-36 will be converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 United States general population. Measured as score on a scale.

  19. Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) version 3

    Time frame: From baseline (week 0) to end of treatment (week 68)

    IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0-100), Physical Function composite (0-100). Total score (0-100). Higher scores indicate better level of functioning.

  20. Number of Treatment-emergent Adverse Events (TEAEs)

    Time frame: From baseline (week 0) to end of study (week 74)

    Count of events

  21. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 milligram per deciliter [mg/dL]), confirmed by blood glucose meter)

    Time frame: From baseline (week 0) to end of study (week 74)

    Count of episodes

  22. Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

    Time frame: From baseline (week 0) to end of study (week 74)

    Count of episodes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2024
Registry last updated
Apr 22, 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.

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