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NCT06131372·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

626

Locations

128

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Cagrilintide

Participants will receive Cagrilintide subcutaneously.

DRUG

Semaglutide

Participants will receive semaglutide subcutaneously.

DRUG

Placebo

Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.

Timeline

From registration to results.

  1. First posted

    Nov 14, 2023

  2. Study start

    Apr 1, 2024

  3. Primary completion

    Sep 24, 2025

  4. Study completion

    Nov 6, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Apr 1, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · From baseline (week 0) to end of treatment (week 26)

Measured in ratio to baseline.

Secondary outcomes

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)

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)

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)

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)

Count of participants.

Achievement of ≥ 10 % weight reduction

Time frame · From baseline (week 0) to end of treatment (week 26)

Count of participants.

Change in waist circumference

Time frame · From baseline (week 0) to end of treatment (week 26)

Measured in centimeter (cm).

Change in glycated haemoglobin (HbA1c)

Time frame · From baseline (week 0) to end of treatment (week 26)

Measured in %-points.

Change in systolic blood pressure

Time frame · From baseline (week 0) to end of treatment (week 26)

Measured in millimeters of mercury (mmHg).

Change in diastolic blood pressure

Time frame · From baseline (week 0) to end of treatment (week 26)

Measured in mmHg.

Number of treatment emergent adverse events (TEAEs)

Time frame · From baseline (week 0) to end of study (week 32)

count of events.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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. 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. * 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.

Study locations

128 registered sites.

Argentina · Brazil · Canada · France · Greece · Hungary · India · Japan · Poland · Slovakia · Spain · Thailand · United States. Showing up to 24 locations stored in the fast local snapshot.

John Muir Physicians Network

Concord, California, United States

Valley Research

Fresno, California, United States

Desert Oasis Hlthcr Med Group

Palm Springs, California, United States

North America Research Institute

San Dimas, California, United States

NorCal Endocrinology and Internal Medicine

San Ramon, California, United States

Northeast Research Institute

Fleming Island, Florida, United States

Life Spring Research Foundation LLC

Miami, Florida, United States

Advent Health Translational Research Institute

Orlando, Florida, United States

Velocity Clin. Res Valparaiso

Valparaiso, Indiana, United States

Elite Research Center

Flint, Michigan, United States

Univ. of Nebraska Medical Center_Omaha

Omaha, Nebraska, United States

Albany Medical College

Albany, New York, United States

NYU Langone Nephrology Associates

Mineola, New York, United States

New York University Grossman School of Medicine

New York, New York, United States

Southgate Medical Group, LLP

West Seneca, New York, United States

Carteret Medical Group

Morehead City, North Carolina, United States

Eastern Nephrology Associates, PLLC

New Bern, North Carolina, United States

Brookview Hills Research Associates, LLC

Winston-Salem, North Carolina, United States

Ohio- Advanced Medical Research

Maumee, Ohio, United States

Heritage Valley Multispeciality Group Inc

Beaver, Pennsylvania, United States

Main Street Physician's Care

Little River, South Carolina, United States

Osvaldo A. Brusco MD

Corpus Christi, Texas, United States

Southwest Houston Research Ltd

Houston, Texas, United States

Clinical Advancement Center

San Antonio, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cagrilintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.