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ARTIST-CKD

Not yet recruitingPhase 2

Albuminuria Reduction Study With Survodutide Treatment in Kidney Disease

Albuminuria Reduction Trial and Investigation With Survodutide Treatment in CKD

Lead sponsor

University Medical Center Groningen

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

120

estimated

Study population

Chronic kidney disease

Key I/E criteria

•BMI ≥21•eGFR 20-90•UACR ≥30

Primary endpoint

•UACR, change

Identifiers

Registered as

NCT IDNCT07206290

Org study ID22774

Secondary ID2025-523184-37-00

Timeline

Milestones

Study first posted2025-10-03actual

Last update posted2025-10-03actual

Study start2026-03-02estimated

Primary completion2027-11-30estimated

Study completion2027-11-30estimated

Assets

Investigational agents

Survodutide

Study populations

Who this study enrolls

Chronic kidney disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 18 years

•eGFR ≥20 and <90 mL/min/1.73m2

•Urinary albumin to creatinine ratio >30 mg/g and <3500 mg/g

•BMI >21 kg/m2

•Stable kidney function (no more than 30% change in eGFR in the 3 months prior to enrolment)

•On a stable maximum tolerated dose of an ACEi/ARB for at least 4 weeks prior to enrolment

•If using an SGLT2 inhibitor, receiving a stable dose for at least 8 weeks prior to enrolment

•Willing to sign an informed consent

Exclusion criteria

•Diagnosis of type 1 diabetes

•Cardiovascular event within 3 months prior to enrolment

•Treatment with GLP-1RA for <12 weeks prior to screening

•Evidence of severe hepatic impairment determined by any one of: ALT or AST values exceeding 3x ULN, a history of hepatic encephalopathy, a history of oesophageal varices, or a history of portocaval shunt;

•Active pregnancy or breastfeeding

•History of kidney or liver transplant

•Active malignancy

•Suggestive evidence of adrenal insufficiency

•Acute pancreatitis <180 days prior to screening

•History of chronic pancreatitis or idiopathic acute pancreatitisPersonal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma

•Calcitonin levels ≥100 pg/mL or 29.26 pmol/L

•Personal history of non-familial medullary thyroid carcinoma

•History of severe hypersensitivity or contraindications to any glucagon RA or GLP-1 RA

•Uncontrolled arterial hypertension (mean semi supine systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg)

•Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:

–History of active inflammatory bowel disease within the 6 months;

–Major gastrointestinal tract surgery as determined by the physician;

–Pancreatitis within 6 months.

–GI ulcers and/or bleeding within 6 months;

–Evidence of urinary obstruction or difficulty in voiding at screening.

•Participation in any clinical trial within 3 months prior to initial dosing.

•Donation or loss of ≧400 ml blood within 8 weeks prior to initial dosing.

•History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening or according to investigator's assessment.

•History of noncompliance to medical regimens or unwillingness to comply with the study protocol.

•Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.

•Women of childbearing potential (WOCBP):

–WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug in such a manner the risk of pregnancy is minimized.

–WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent of HCG) at screening.

•Vulnerable (i.e. under guardianship) or mentally incapacitated subjects (i.e. not able to understand and sign the informed consent)

Endpoints (13)

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

Renal / kidney

Weight & body composition

Cardiometabolic biomarkers

Glycemic / diabetes

Heart failure

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Perirenal and renal sinus fat measured by MRI

Time frame:From baseline to week 36

change from baseline, improvement

Secondary/protocol endpoint

Subcutaneous and visceral fat assessed by MRI

Time frame:From baseline to week 36

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Body weight

Time frame:From baseline to week 36

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:From baseline to week 36

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Other/protocol endpoint

HbA1c

Time frame:From baseline to week 36

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Heart failure

1 endpoint

Other/protocol endpoint

NT-proBNP

Time frame:From baseline to week 36

NT-proBNP, change

change from baseline, improvement

Renal / kidney

5 endpoints

Primary/protocol endpoint

Change in first morning void UACR

Time frame:From baseline to week 32/36

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

eGFR (creatinine, cystatin C, and creatinine-cystatin C)

Time frame:From baseline to week 36

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Iohexol measured GFR

Time frame:From baseline to week 36

eGFR, change

change from baseline, improvement

Secondary/protocol endpoint

UACR and eGFR during 4-week wash-out

Time frame:From week 36 to 40

descriptive

Other/protocol endpoint

Renal blood flow measured by MRI

Time frame:From baseline to week 36

change from baseline, descriptive

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Systolic and diastolic blood pressure

Time frame:From baseline to week 36

change from baseline, improvement

Other/protocol endpoint

High-sensitivity C-reactive protein

Time frame:From baseline to week 36

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

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.