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

NCT06131372
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Completed
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Participants
626
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Lead sponsor
Novo Nordisk A/S
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Start date
2024-04-01
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Number of sites
128
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Summary
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.
clinicaltrials.gov
Short title
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
clinicaltrials.gov
Official title
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-11-06
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First posted
2023-11-14
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Registry last updated
2026-04-01
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Primary completion date
2025-09-24
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Start date
2024-04-01
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Actual participants
626
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Participants
626
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
128
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Novo Nordisk A/S
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06131372
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06131372
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Change in urinary albumin-to-creatinine ratio (UACR)

    Timeframe: From baseline (week 0) to end of treatment (week 26)

    Measured in ratio to baseline.

  1. Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based chronic kidney disease (CKD)-Epidemiology Collaboration equation (EPI) 2021)

    Timeframe: 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).

  2. Change in eGFR (creatinine-based CKD-EPI 2021)

    Timeframe: From baseline (week 0) to end of treatment (week 26)

    Measured in mL/min/1.73 m\^2.

  3. Relative change in body weight

    Timeframe: From baseline (week 0) to end of treatment (week 26)

    Measured in percentage (%).

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

    Timeframe: From baseline (week 0) to end of treatment (week 26)

    Count of participants.

  5. Achievement of ≥ 10 % weight reduction

    Timeframe: From baseline (week 0) to end of treatment (week 26)

    Count of participants.

  6. Change in waist circumference

    Timeframe: From baseline (week 0) to end of treatment (week 26)

    Measured in centimeter (cm).

  7. Change in glycated haemoglobin (HbA1c)

    Timeframe: From baseline (week 0) to end of treatment (week 26)

    Measured in %-points.

  8. Change in systolic blood pressure

    Timeframe: From baseline (week 0) to end of treatment (week 26)

    Measured in millimeters of mercury (mmHg).

  9. Change in diastolic blood pressure

    Timeframe: From baseline (week 0) to end of treatment (week 26)

    Measured in mmHg.

  10. Number of treatment emergent adverse events (TEAEs)

    Timeframe: From baseline (week 0) to end of study (week 32)

    count of events.

  11. Number of treatment emergent serious adverse events (SAEs)

    Timeframe: From baseline (week 0) to end of study (week 32)

    count of events.

  12. 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]))

    Timeframe: From baseline (week 0) to end of study (week 32)

    Count of episodes.

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

    Timeframe: From baseline (week 0) to end of study (week 32)

    Count of episodes.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Male or female.
  • Age 18 years or above at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
  • Body mass index (BMI) ≥ 27.0 kilograms per meter square (kg/m^2) at screening. BMI will be calculated in the eCRF (electronic case report form) based on height and body weight at screening.
  • HbA1c less than or equal to (≤) 10.5% (91 millimoles per mole [mmol/mol]) as assessed by central laboratory at screening.
  • Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and < 90 milliliters per minutes per 1.73^m^2 (mL/min/1.73 m^2) (CKD-EPI 2021) as assessed by central laboratory at screening.
  • Albuminuria defined by UACR ≥ 100 and < 5000 milligram per gram (mg/g) as assessed by central laboratory at screening.
  • Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening.

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
  • Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
  • Use of any glucagon-like peptide-1 receptor agonist (GLP-1RA) (including medication with GLP-1RA activity, e.g., GIP/GLP-1RA) or amylin analogue within 60 days prior to screening.
  • Myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 60 days before screening.
  • Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening.
  • 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.
  • Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN) within 5 years before screening.
Sources for eligibility
clinicaltrials.gov

  • John Muir Physicians NetworkConcord, United States
  • Valley ResearchFresno, United States
  • Desert Oasis Hlthcr Med GroupPalm Springs, United States
  • North America Research InstituteSan Dimas, United States
  • NorCal Endocrinology and Internal MedicineSan Ramon, United States
  • Northeast Research InstituteFleming Island, United States
  • Life Spring Research Foundation LLCMiami, United States
  • Advent Health Translational Research InstituteOrlando, United States
  • Velocity Clin. Res ValparaisoValparaiso, United States
  • Elite Research CenterFlint, United States
  • Univ. of Nebraska Medical Center_OmahaOmaha, United States
  • Albany Medical CollegeAlbany, United States
  • NYU Langone Nephrology AssociatesMineola, United States
  • New York University Grossman School of MedicineNew York, United States
  • Southgate Medical Group, LLPWest Seneca, United States
  • Carteret Medical GroupMorehead City, United States
  • Eastern Nephrology Associates, PLLCNew Bern, United States
  • Brookview Hills Research Associates, LLCWinston-Salem, United States
  • Ohio- Advanced Medical ResearchMaumee, United States
  • Heritage Valley Multispeciality Group IncBeaver, United States
  • Main Street Physician's CareLittle River, United States
  • Osvaldo A. Brusco MDCorpus Christi, United States
  • Southwest Houston Research LtdHouston, United States
  • Clinical Advancement CenterSan Antonio, United States
  • Clinical Investigation Specialists Inc, KenoshaKenosha, United States

And 103 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-505857-42
  • U1111-1291-5907
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (4)

Targets (1)