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Trial · Interventional

CompletedPhase 3Registry data

SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes

Short name SMART

NCTNCT04889183 (opens ClinicalTrials.gov in a new tab)Other id202100166Other id2021-001247-27
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
125 participants (actual)
Sponsor
University Medical Center Groningen · Other
Design
Randomized · Quadruple masking
Countries
4 countries

Canada, Germany, Netherlands, Spain

Start
14 Mar 2022
Primary completion
28 May 2024
Completion
28 May 2024
First posted
17 May 2021
Last update posted
22 Apr 2025
Conditions
Obesity · Albuminuria

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. Ph 3

    SMART

    NCT04889183

    14 Mar 2022 to 28 May 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Study to assess the effects of weekly subcutaneous administration of the GLP1-RA semaglutide 2.4mg on kidney function parameters in obese/overweight individuals at high risk of CKD progression.

Interventions

  • SemaglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Semaglutide

    Patients will be treated with semaglutide 3 mg/ml s.c. once weekly for 24 weeks. The starting dose of semaglutide will be 0.24 mg subcutaneous injection with increasing doses at 4, 8, 12, and 16 weeks to 0.5, 1,0, 1.7 and 2.4 mg once weekly.

  • Placebo comparator

    Placebo

    Patients will receive a matching placebo s.c. once weekly.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Week 1 to week 24

    Registry description

    Measured in first morning void

Secondary outcomes(9)

  1. estimated glomerular filtration rate (eGFR)

    Time frame · Week 1 to week 24

    Registry description

    Change from baseline to week 24 in estimated glomerular filtration rate (eGFR)

  2. Iohexol measured glomerular filtration rate (GFR)

    Time frame · Week 1 to week 24

    Registry description

    Change from baseline to week 24 in Iohexol measured glomerular filtration rate (GFR)

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

    Time frame · week 24 to 28

    Registry description

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

  4. estimated glomerular filtration rate (eGFR) during wash-out

    Time frame · week 24 to 28

    Registry description

    Change in estimated glomerular filtration rate (eGFR) during wash-out

  5. body weight

    Time frame · Week 1 to week 24

    Registry description

    Change from baseline to week 24 in body weight

  6. hip circumference

    Time frame · Week 1 to week 24

    Registry description

    Change from baseline to week 24 in hip circumference

  7. systolic and diastolic blood pressure

    Time frame · Week 1 to week 24

    Registry description

    Change from baseline to week 24 in systolic and diastolic blood pressure

  8. extracellular fluid

    Time frame · Week 1 to week 24

    Registry description

    Change from baseline to week 24 in extracellular fluid as measured by bio-impedance

  9. high sensitivity C-reactive protein (CRP)

    Time frame · Week 1 to week 24

    Registry description

    Change from baseline to week 24 in high sensitivity C-reactive protein (CRP)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2026

7 results

Effects of Semaglutide on Body Composition and GFR: A Prespecified Analysis of the SMART Trial.

Heerspink et al. 2026Clinical journal of the American Society of Nephrology : CJASNcited by 1

PMID 42308057PMC13379112DOI 10.2215/cjn.0000001051PUB-42308057

Rights unknown7 results
Source linkSee results (7)

Indexing hint: Randomized controlled trial · 2025

2 results

Semaglutide in patients with overweight or obesity and chronic kidney disease without diabetes: a randomized double-blind placebo-controlled clinical trial.

Apperloo et al. 2025Nature medicinecited by 93

PMID 39455729DOI 10.1038/s41591-024-03327-6PUB-39455729

Full text at the publisher2 results
Publisher pageSee results (2)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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