DelfaGLP-1 Atlas

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CompletedPhase 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

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

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

128

Recruiting sites

—

Enrollment

626

actual

Study population

Chronic kidney disease, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•eGFR 15-90•UACR 100-5000

Primary endpoint

•UACR, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06131372
Org study IDNN9388-7700
Secondary ID2023-505857-42
Secondary IDU1111-1291-5907World Health Organization (WHO)

Timeline

Milestones

Study first posted2023-11-14actual
Study start2024-04-01actual
Primary completion2025-09-24actual
Study completion2025-11-06actual
Last update posted2026-04-01actual

Assets

Investigational agents

CagriSema / cagrilintideSemaglutide

Study populations

Who this study enrolls

Chronic kidney diseaseObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
4
Safety / tolerability / PK
4
Renal / kidney
3
Cardiometabolic biomarkers
2
Glycemic / diabetes
1

Weight & body composition

4 endpoints
Secondary/protocol endpoint

Relative change in body weight

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

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

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of ≥ 10 % weight reduction

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

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist circumference

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

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Renal / kidney

3 endpoints
Primary/protocol endpoint

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

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

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

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)

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

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

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

eGFR, change

change from baseline, improvement

LOINC 98979-8

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change in systolic blood pressure

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

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

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment emergent serious adverse events (SAEs)

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

Serious AEs (any)

event count, event

Secondary/protocol endpoint

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)

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

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)

Severe hypoglycemia

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.