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SMART

CompletedPhase 3

SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

13

Recruiting sites

Enrollment

125

actual

Study population

Chronic kidney disease, Obesity / overweight

Key I/E criteria

BMI ≥27eGFR ≥25

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 IDNCT04889183
Org study ID202100166
Secondary ID2021-001247-27

Timeline

Milestones

Study first posted2021-05-17actual
Study start2022-03-14actual
Primary completion2024-05-28actual
Study completion2024-05-28actual
Last update posted2025-04-22actual

Assets

Investigational agents

Study populations

Who this study enrolls

Chronic kidney diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Age ≥ 18 years
Body Mass index ≥ 27 kg/m2
Albuminuria ≥ 30 mg/g and ≤ 3500 mg/g
eGFR ≥ 25 ml/min/1.73m2
Stable renal function prior to entry into the study defined as no more than 30% eGFR change in 3 months prior to enrolment
Signed Informed Consent

Exclusion criteria

Diagnosis with type 1 or type 2 Diabetes
Hba1c ≥ 6.5% at screening
Cardiovascular disease event in 3 months prior to enrollment
Treatment with GLP-1 RA < 4 weeks prior to screening
Uncontrolled thyroid disease TSH>6.0 mIU/L or <0.4 mIU/L at screening
Acute pancreatitis < 180 days prior to screening
History or presence of chronic pancreatitis
Females of child-bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures

Endpoints (10)

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
5
Weight & body composition
3
Cardiometabolic biomarkers
2

Weight & body composition

3 endpoints
Secondary/protocol endpoint

body weight

Time frame:Week 1 to week 24

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

hip circumference

Time frame:Week 1 to week 24

change from baseline, improvement

Secondary/protocol endpoint

extracellular fluid

Time frame:Week 1 to week 24

change from baseline, improvement

Renal / kidney

5 endpoints
Primary/protocol endpoint

Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR)

Time frame:Week 1 to week 24

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

estimated glomerular filtration rate (eGFR)

Time frame:Week 1 to week 24

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Iohexol measured glomerular filtration rate (GFR)

Time frame:Week 1 to week 24

eGFR, change

change from baseline, improvement

Secondary/protocol endpoint

urinary albumin:creatinine ratio (UACR) during wash-out

Time frame:week 24 to 28

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

estimated glomerular filtration rate (eGFR) during wash-out

Time frame:week 24 to 28

eGFR, change

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

systolic and diastolic blood pressure

Time frame:Week 1 to week 24

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Secondary/protocol endpoint

high sensitivity C-reactive protein (CRP)

Time frame:Week 1 to week 24

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.