Cagrilintide
DrugCagrilintide will be administered subcutaneously.
NCT Number: NCT06221969
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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Notify Me18 year and older
All sexes
Interventional
Phase 3
Buenos Aires Mácula, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cagrilintide will be administered subcutaneously.
Semaglutide will be administered subcutaneously.
Tirzepatide will be administered subcutaneously.
Time frame: From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%)-points.
Time frame: From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 68)
Measured in %-points.
Time frame: From baseline (week 0) to end of treatment (week 68)
Measured in millimoles per liter (mmol/L).
Time frame: At end of treatment (week 68)
Count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
Count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
Count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
Count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
Count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
Count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
Measured in millimeters of mercury(mmHg).
Time frame: From baseline (week 0) to end of treatment (week 68)
Measured in mmHg.
Time frame: From baseline (week 0) to end of treatment (week 68)
Measured in centimeter (cm).
Time frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
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.
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.
Time frame: From baseline (week 0) to end of study (week 74)
Count of events
Time frame: From baseline (week 0) to end of study (week 74)
Count of episodes
Time frame: From baseline (week 0) to end of study (week 74)
Count of episodes
Novo Nordisk A/S
Industry
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
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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