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ObesityPhase 3SMARTNCT04889183

SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes

A Phase 3 study testing Semaglutide in people with Obesity and Albuminuria, run by University Medical Center Groningen at 13 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Albuminuria
What is being tested?
Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
125 participants
Where
13 sitesin 4 countries
Study dates
14 Mar 2022to 28 May 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

13 sites in 4 countries.

13 sites in 4 countries

Netherlands5 sites

  • Dept Internal Medicine, division of Nephrology Hospital Group Twente

    Almelo, 7609 PP

  • Rijnstate

    Arnhem, Gelderland, 6815 AD

  • University Medical Center Groningen

    Groningen, Provincie Groningen, 9713 GZ

  • Martini Ziekenhuis

    Groningen, Provincie Groningen, 9728 NT

  • Isala

    Zwolle, Overijssel, 8025 AB

Other trials in Netherlands

Spain4 sites

  • Vall d'Hebron University Hospital

    Barcelona, 08035

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Hospital Da Costa Burela

    Lugo, 27880

  • Hospital Clínico Universitario

    Valencia, 46010

Other trials in Spain

Canada2 sites

  • University of Calgary

    Calgary, Alberta, 3230

  • Division of Nephrology University Health Network, University of Toronto

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Germany2 sites

  • University Hospital Erlangen

    Erlangen, 91054

  • University Hospital Wuerzburg

    Würzburg, 97080

Other trials in Germany

About this study

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.

Read the detailed description

Glucagon Like Peptide 1 Receptor Agonist (GLP1-RA) therapies have been introduced as antidiabetic drugs. In addition, GLP1-RA therapies reduce body weight, in patients with and without diabetes, without inducing hypoglycemia. Moreover, GLP1-RA reduce albuminuria in patients with type 2 diabetes, and liraglutide and semaglutide have been shown to improve various risk markers of CKD progression in non-diabetic obese individuals. It is therefore likely that these agents delay progression of kidney function decline in high risk obese/overweight, non-diabetic individuals.

The main objective of the study is to assess the albuminuria lowering effects of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) compared to placebo in obese/overweight non-diabetic individuals with elevated albuminuria. This will be tested in a 24-week randomized placebo controlled double-blind two arm parallel clinical trial with a 4 week wash-out period after 24 weeks double blind treatment to assess off drug effects.

Conditions
Obesity, Albuminuria
Being tested
Semaglutide, Placebo
Keywords
SMART, Semaglutide, UMCG, Lambers Heerspink
Medical subject headings
Obesity, Albuminuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Patients will be treated for 24 weeks with semaglutide 3.0 mlg/ml s.c. once weekly. The starting dose of semaglutide will be 0.24 mg per week subcutaneous injection with increasing doses at 4, 8, 12, and 16 weeks to 0.5, 1,0, 1.7 and 2.4 mg.

  • PlaceboDrug

    Patients will receive a matching placebo sc. once weekly during the treatment period of 24 weeks.

Study groups in NCT04889183
Study groupRoleWhat they receive
SemaglutideExperimentalPatients 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.
Receives: Drug: Semaglutide
PlaceboPlacebo comparatorPatients will receive a matching placebo s.c. once weekly.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured in first morning void

    Measured: Week 1 to week 24

Secondary outcomes (9)

  1. estimated glomerular filtration rate (eGFR)

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

    Measured: Week 1 to week 24

  2. Iohexol measured glomerular filtration rate (GFR)

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

    Measured: Week 1 to week 24

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

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

    Measured: week 24 to 28

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

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

    Measured: week 24 to 28

  5. body weight

    Change from baseline to week 24 in body weight

    Measured: Week 1 to week 24

  6. hip circumference

    Change from baseline to week 24 in hip circumference

    Measured: Week 1 to week 24

  7. systolic and diastolic blood pressure

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

    Measured: Week 1 to week 24

  8. extracellular fluid

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

    Measured: Week 1 to week 24

  9. high sensitivity C-reactive protein (CRP)

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

    Measured: Week 1 to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2021
  2. Study start14 Mar 2022
  3. Primary completion28 May 2024
  4. Study completion28 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized placebo controlled double-blind two arm parallel clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04889183
Sponsor's protocol ID
202100166
Other IDs
2021-001247-27
Acronym
SMART
Status last verified
Nov 2024
First submitted
6 May 2021
Last updated
22 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Heerspink HJL, Soler M, Beernink JM, Jongs N, Cigarran S, Cruzado JM, Puchades MJ, Lopez-Martinez M, Apperloo E, Waanders F, Laverman GD, van der Aart-van der Beek A, van Beek AP, Verhave JC, Ahmed SB, Schmieder RE, Wanner C, Cherney DZI, Gorriz JL. Effects of Semaglutide on Body Composition and GFR: A Prespecified Analysis of the SMART Trial. Clin J Am Soc Nephrol. 2026 Jul 1;21(7):1149-1158. doi: 10.2215/CJN.0000001051. Epub 2026 Apr 30.

    PubMed 42308057

  • Apperloo EM, Gorriz JL, Soler MJ, Cigarran Guldris S, Cruzado JM, Puchades MJ, Lopez-Martinez M, Waanders F, Laverman GD, van der Aart-van der Beek A, Hoogenberg K, van Beek AP, Verhave J, Ahmed SB, Schmieder RE, Wanner C, Cherney DZI, Jongs N, Heerspink HJL. Semaglutide in patients with overweight or obesity and chronic kidney disease without diabetes: a randomized double-blind placebo-controlled clinical trial. Nat Med. 2025 Jan;31(1):278-285. doi: 10.1038/s41591-024-03327-6. Epub 2024 Oct 25.

    PubMed 39455729

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide in people with Obesity and Albuminuria, run by University Medical Center Groningen at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Netherlands, Spain, Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR) (time frame: Week 1 to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04889183, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.

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