Cagrilintide
DrugParticipants will receive Cagrilintide subcutaneously.
NCT Number: NCT06131372
This study will look if CagriSema can lower kidney damage in people with chronic kidney disease (CKD), type 2 diabetes (T2D) and overweight or obesity. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors. The study will compare CagriSema to the 2 medicines semaglutide and cagrilintide, when they are taken alone. It will also compare CagriSema to a "dummy" medicine (also called placebo) without any active ingredient. Participant will either get CagriSema, semaglutide, cagrilintide or placebo. Which treatment participant will get is decided by chance (like flipping a coin). Study doctor will not know which of the study medicines participant will get. For each participant, the study will last for about 35 weeks.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Mautalen Salud e investigación, CABA, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive Cagrilintide subcutaneously.
Participants will receive semaglutide subcutaneously.
Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.
Time frame: From baseline (week 0) to end of treatment (week 26)
Measured in ratio to baseline.
Time frame: From baseline (week 0) to end of treatment (week 26)
Measured in milliliters per minute per 1.73 meters square (mL/min/1.73 m^2).
Time frame: From baseline (week 0) to end of treatment (week 26)
Measured in mL/min/1.73 m^2.
Time frame: From baseline (week 0) to end of treatment (week 26)
Measured in percentage (%).
Time frame: From baseline (week 0) to end of treatment (week 26)
Count of participants.
Time frame: From baseline (week 0) to end of treatment (week 26)
Count of participants.
Time frame: From baseline (week 0) to end of treatment (week 26)
Measured in centimeter (cm).
Time frame: From baseline (week 0) to end of treatment (week 26)
Measured in %-points.
Time frame: From baseline (week 0) to end of treatment (week 26)
Measured in millimeters of mercury (mmHg).
Time frame: From baseline (week 0) to end of treatment (week 26)
Measured in mmHg.
Time frame: From baseline (week 0) to end of study (week 32)
count of events.
Time frame: From baseline (week 0) to end of study (week 32)
count of events.
Time frame: From baseline (week 0) to end of study (week 32)
Count of episodes.
Time frame: From baseline (week 0) to end of study (week 32)
Count of episodes.
Novo Nordisk A/S
Industry
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Semaglutide 2.4 mg, Cagrilintide 2.4 mg and Placebo in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity
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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