Trial · Interventional
CompletedPhase 2Registry dataA Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 626 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Quadruple masking
- Countries
13 countries
United States, Argentina, Brazil, Canada, France, Greece, Hungary, India, Japan, Poland, Slovakia, Spain, Thailand
- Start
- 1 Apr 2024
- Primary completion
- 24 Sept 2025
- Completion
- 6 Nov 2025
- First posted
- 14 Nov 2023
- Last update posted
- 24 Sept 2026
- Conditions
- Chronic Kidney Disease · Type 2 Diabetes · Obesity
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo
NCT061313721 Apr 2024 to 6 Nov 2025
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- CagrilintideDrug
- SemaglutideDrug
- PlaceboDrug
Arms4
Experimental
CagriSema
Participants will receive cagrilintide and semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.
Experimental
Semaglutide
Participants will receive semaglutide and placebo matched to cagrilintide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.
Experimental
Cagrilintide
Participants will receive cagrilintide and placebo matching to semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.
Placebo comparator
Placebo
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously once weekly for 26 weeks.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in urinary albumin-to-creatinine ratio (UACR)
Time frame · From baseline (week 0) to end of treatment (week 26)
Registry description
Measured in ratio to baseline.
Secondary outcomes(13)
Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based chronic kidney disease (CKD)-Epidemiology Collaboration equation (EPI) 2021)
Time frame · From baseline (week 0) to end of treatment (week 26)
Registry description
Measured in milliliters per minute per 1.73 meters square (mL/min/1.73 m\^2).
Change in eGFR (creatinine-based CKD-EPI 2021)
Time frame · From baseline (week 0) to end of treatment (week 26)
Registry description
Measured in mL/min/1.73 m\^2.
Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 26)
Registry description
Measured in percentage (%).
Achievement of greater than or equal to (≥) 5 % weight reduction
Time frame · From baseline (week 0) to end of treatment (week 26)
Registry description
Count of participants.
Achievement of ≥ 10 % weight reduction
Time frame · From baseline (week 0) to end of treatment (week 26)
Registry description
Count of participants.
Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 26)
Registry description
Measured in centimeter (cm).
Change in glycated haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 26)
Registry description
Measured in %-points.
Change in systolic blood pressure
Time frame · From baseline (week 0) to end of treatment (week 26)
Registry description
Measured in millimeters of mercury (mmHg).
Change in diastolic blood pressure
Time frame · From baseline (week 0) to end of treatment (week 26)
Registry description
Measured in mmHg.
Number of treatment emergent adverse events (TEAEs)
Time frame · From baseline (week 0) to end of study (week 32)
Registry description
count of events.
Number of treatment emergent serious adverse events (SAEs)
Time frame · From baseline (week 0) to end of study (week 32)
Registry description
count of events.
Number of clinically significant hypoglycaemic episodes (level 2) ( blood glucose less than [<] 3.0 millimoles per liter [mmol/L] (54 milligram per deciliter [mg/dL]))
Time frame · From baseline (week 0) to end of study (week 32)
Registry description
Count of episodes.
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 32)
Registry description
Count of episodes.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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